State Consumer Disputes Redressal Commission
Anita Bhati vs Gargi Hospital on 19 April, 2023
Cause Title/Judgement-Entry STATE CONSUMER DISPUTES REDRESSAL COMMISSION, UP C-1 Vikrant Khand 1 (Near Shaheed Path), Gomti Nagar Lucknow-226010 Complaint Case No. CC/392/2018 ( Date of Filing : 20 Nov 2018 ) 1. Anita Bhati Ghaziabad ...........Complainant(s) Versus 1. Gargi Hospital Ghaziabad ............Opp.Party(s) BEFORE: HON'ABLE MR. JUSTICE PRESIDENT PRESIDENT HON'BLE MR. Rajendra Singh JUDICIAL MEMBER HON'BLE MR. SUSHIL KUMAR JUDICIAL MEMBER PRESENT: Dated : 19 Apr 2023 Final Order / Judgement Complaint no.392/2018 Mrs. Amita Bhati s. Gargi Hospital & ors. 19.4.2023 Called out. Ld. counsel for the complainant Sri Hemraj Mishra is present. Ld. counsel for the opposite parties no.1 & 2 Sri Adil Ahmad is present. Adjournment given by the opposite party no.3 which is New India Assurance Co. Ltd. who has no main role in the present case. Hence, adjournment is rejected. Heard argument. Judgment is reserved. (Sushil Kumar) (Rajendra Singh) Member Presiding Member Jafri, PA I Court 2 Reserved State Consumer Disputes Redressal Commission U.P. Lucknow. Complaint Case No.392 of 2018 Mrs. Anita Bhati w/o Sh. Jagdish Kumar Bhati, R/o H.No.214, Sector-23, Raj Nagar, Ghaziabad, U.P. ...Complainant. Versus 1- Gargi Hospital, A unit of Kaushalya Medical & Research Center Pvt. Ltd., R-9/182, Raj Nagar, Near Alt Center, Ghaziabad, U.P. 2- Dr. Ajit Kapoor, Gargi Hospital, A unit of Kaushalya Medical & Research Center Pvt. Ltd., R-9/182, Raj Nagar, Near Alt Center, Ghaziabad, U.P. ...Opposite parties. Present:- 1- Hon ble Sri Rajendra Singh, Member. 2- Hon ble Sri Sushil Kumar, Member. Sri A.K. Mishra, Advocate for the complainants. Sri V.K. Mishra, Advocate for OP. Date : 31.05.2023 JUDGMENT
Per Sri Rajendra Singh, Member- This complainthas been filed by the complainant for following reliefs:
1- To refund a sum of Rs.20,00,000.00 it includes the fees received by opposite party no.1 & 2 and the expenses incurred in Fortis Hospital and after that expenses incurred in other tests in various Diagnostic Centres and expenses on medicines and also including the expenses of Rs.16,00,000.00 in Jaypee Hospital for major surgery of complainant.
2- To pay interest @ 18% over the sum as paid to opposite party.
3- To pay a sum of Rs.50,00,000.00 towards the harassment, shock and mental agony and for the permanent disability and strength incurred due to the wrong operative methods and gross negligence.
4- Any other relief which this Hon ble Commission deems fit and proper may also be passed in favour of the complainant and against the opposite party, in the interest of justice.
The brief facts of the complaint are that, the patient is 42 years old lady and she was an ex-corporator in Municipal Corporation, Distt. Ghaziabad, U.P. living with her family in Ghaziabad. The present case is depicting gross negligence in a manner constituting gross breach of duties undergoing the treatment and also adopting a wrong procedure in the operation of complainant.
The complainant visited opposite party no.2 for the treatment of her abdomen pain. On the prescription the opposite party advised complainant for Ultrasound and on the basis of Ultrasound report opposite party suggested complainant for the laparoscopy cholecystectomy (removal of gallbladder). On the utmost good faith complainant decided to undergo the above treatment and it was done on 6.7.2017 and complainant was discharged on 8.7.2017 from opposite party no.1. On being discharge the complainant having pain in her abdomen and this was told by the complainant to the opposite party but the opposite party told complainant that it is the normal symptom and it will decrease after 2-3 days.
On the date of the follow up prescribed by opposite party on 10.7.2017, complainant told about her discomfort and unbearable pain in the abdomen. Opposite party suggested for the USG of whole abdomen. Which was done in Diwan Diagnostic Center where the MRI Cholangiopancreaticography was done on 11.7.2017. In that MRI report, free fluid extending with GB Fossa in the common bile duct was seen. It means that there is leakage in CBD of complainant.
On visiting to opposite party for MRCP, opposite party did not tell the complainant about the actual situation, about the injury of CBD caused by opposite party due to opposite party due to his irresponsibility and also about CBD leakage by not adopting proper procedure and the opposite party sent complaint for MRCP at Fortis Hospital, Shalimar Bagh, Delhi. On reference/prescription of the opposite party, the complainant went to the Fortis Hospital for MRCP where it was done and Fortis Hospital report ( UTD registration no.0368438) shows minor leak from cystic duct and impression CBD. Due to this situation complainant is in too much of her discomfort and there is an increasing pain and swelling of the stomach.
It is pertinent to mention here that Fortis Hospital has denied to take any further step and sent back the complainant to opposite party no.2 after ERCP on 12.7.2017. The complainant regularly followed the medical advice as prescribed by opposite party. At this stage, complainant s situation became very grim and due to unbearable pain and weakness her life is in danger and her stomach swollen due to the CBD injury/leak. Again the complainant shows the ERCP report to opposite party no.2 but inspite of telling the truth, opposite party sent the complainant to Jaypee Hospital, Dr. Rajesh Kapoor. In Jaypee Hospital, complainant was admitted on 13.7.2017 and she has gone through a major operation of her abdomen. The discharge report clearly shows that in Post Laparoscopy Cholecystectomy done on 6.7.2017, there is mild to moderate free fluid and also the mild free fluid is seen in the right pleural cavity due to the leakage and during the operation opposite party have not taken the appropriate steps as per requirement at that time. After that complainant was discharged on 26.7.2017 and on this operation huge amount of expenditure of Rs.16,00,000.00 incurred.
Again on follow up the complainant was admitted in Jaypee Hospital on 2.8.2017 and went through all the relevant examination, such as X-ray Tests-AP done on 4.8.2017. The discharge report shows that complainant underwent exploratory with drainage or collection with lavage of the retro peritoneal cavity done under G.A. on 3.8.2017, done on 2.8.2017 showed bulky unccinate process and head of pancreas with adjacent small localized collection.
From 6.7.2017, the complainant s situation is not well till date and she became weak and having a regular pain in her abdomen. It is all due to the wrong treatment and injury after the laparoscopy cholecystectomy in the CBD and leak which shows opposite party sheer medical incompetent and money making mind of opposite party the addressee no.1 & 2 and in the span of one month from 5.7.2017 till date complainant is fighting for life and she reached nearly on the death bed due to the failure of the opposite party treatment. The complainant and her family is suffering from a mental trauma and pain and complainant situation is very bad. She is not fit as she has a political carrier in her part, she lost all her strength and also suffered a socio and economic loss. It is due to opposite party gross negligence and deficiency in services and also non compliance of the rules of medical services.
The complainant suffered from mental trauma and harassment and loss of valuable money because of gross negligence and unfair trade practice by opposite party and also due to lack of services.
The opposite parties no.1 & 2 filed their written statement stating therein that the instant complaint is not maintainable before this Hon ble Commission as the complainant has only put bills for an amount of Rs. 6,05,999/- which admittedly do not meet the criteria for invoking the pecuniary jurisdiction of this Hon ble commission and therefore, the instant complaint is liable to be dismissed on this account itself.
The instant complaint is without any merit, an abuse of the process of law and is liable to be dismissed as such by this Hon ble commission.
The present complaint is inconsistent in its approach and does not disclose the complete set of facts and as such proceeds on surmises, conjectures and blatantly incorrect facts. It is submitted that the complainant is liable for non-disclosure of material facts/documents and the relevancy of the said documents/facts shall be pointed out at the specific place in the present written statement.
The entire complaint of the complainant is based on the allegation that the procedure of Laparoscopic cholecystectomy (hereinafter "Procedure") carried out on the complainant by the answering opposite parties 1 and 2 was done in a manner depicting gross negligence and constituted gross breach of duties while providing treatment to the complainant and also for adoption of wrong procedure in the operation of the complainant. Therefore, the allegations of the complainant can be broadly categorized in to the following sub-heads:
(i) Gross Negligence;
(ii) Gross Breach of duties; and
(iii) Adoption of wrong procedure.
As regards "Gross Negligence", it is stated that there was no negligence whatsoever, whether mild or gross. As a matter of fact, there was no negligence in terms of the definition of negligence provided by the Hon ble Supreme court in Laxman Balakrishan Joshi vs. Trimbar Bapu Godbole and anr., AIR 1969 SC 128, reproduced below:
The duties which a doctor owes to his patient are clear. A person who holds himself out ready to give medical advice and treatment impliedly undertakes that he is possessed of skill and knowledge for the purpose. Such a person when consulted by a patient owes him certain duties, viz., a duty of care in deciding whether to undertake the case, a duty of care in deciding what treatment to give or a duty of care in the administration of that treatment. A breach of any of those, duties gives a right of action for negligence to, the patient. The practitioner must bring to his task a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence judged in the light of the particular circumstances of each case is what the law require: (cf. Halsbury s Laws of England 3rd ed. vol. 26 p. 17)".It is stated that there was no negligence in treating the patient. The complication that occurred was a known complication that occurs in such patients without any fault on the part of the doctor.
As regards "Gross Breach of Duties: there was no breach of duty whatsoever. As per the Laxman Balakrishan Joshi judgment cited above, a doctor owes three duties towards the patient- "Such a person when consulted by a patient, owes certain duties, viz., a duty of care in deciding whether to undertake the case, a duty of care in deciding what treatment to give, and a duty of care in the administration of that treatment. A breach of any of those duties gives a right of action of negligence to the patient". The complainant has not proved that there was breach of any of these three duties. It is to be remembered that the onus to prove negligence lies upon the complainant.
As regards "Adoption of wrong procedure", this is a purely technical/medical issue. It is not for the patient or a layman to allege, without proof, that there was "Adoption of wrong procedure" on the part of the treating doctor. Such allegation must be supported by proof/expert opinion. None has been provided by the complainant. A bland and vague allegation has no meaning and has to be dismissed ab initio.
The need for expert opinion in cases involving medical issues has been emphasized in a large number of judgments, some of which are quoted below:
I- Jacob Mathew v. State of Punjab & anr., (2005)6 SCC I; 2005 SCCL.COM 456.
II- Martin F D Souza vs. Mohd. Ishfaq, 157(2009) DLT 391 (SC); 2009(3)SCC 1".
III- Salemuddin & ors. vs. Dr. Sunil Kalhotr, III(2006) CPJ 396 NC.
IV- Narsimha Reddy (deceased) & ors. vs. Rohini Hospital & anr., NC 2005 CTJ 855 (CP) NC V- Upasana Hospital & arn. Vs. S. Farook, II(2007) CPJ 235 (NC) VI- Dr. Hemant Chopra & anr. vs. Kulwinder Singh & ors., IV(2011) CPJ 677 (NC) VII- Baburao Satappa Irrannanavar vs. Kle Society s Hospital, 4(2006) CPJ 71 (NC), VIII- That for purpose of quick appreciation, the brief medical facts/chain of events are recapitulated below:
Brief Facts:
5.7.2017 Complainant visited OP hospital.
6.7.2017 Laparoscopic Cholecystectomy was done after obtaining a written consent dated 6.7.2017 after explaining in detail various possible complications.
117.2017 Patient complained of unbearable pain. MRI-MRCP was advised. Got done at Deewan Diagnostics. It was reported as -"Impression-Short segment of narrowing in upper one third of CBD (Common Bile Duct). Advise-ERCP for further evaluation".
12.7.2017 ERCP was done at Fortis Hospital. It was reported as: "Findings- Papilla-small, tight, edematous.
CBD- Normal in caliber. No stone seen? Minor leak from cystic duct stump seen. Needle knife papillotomy done.
Guidewire could not be negotiated into CBD MPD (Main Pancreatic Duct)-Normal Impression-CBD leak, Papillotomy done.
13.7.2017 OP referred the patient to Jay Pee Hospital, where she was admitted and operated. Discharged from t here on 26.7.2017.
13.7.2017 Ultrasound examination of the whole abdomen revealed the following:
I. "Pancreas is diffusely bulky and appears edematous obscured by bowel gases-most likely pancreatitis. There is evidence of stranding of peripancreatic and right perinephric fat seen. (Advised serum amylase/lipase and CECT abdomen)."
II. "Bowel loops are distended and gaseous."
III. "There is mild-moderate amount of free fluid noted in the pelvis and pre-hepatic space (approx.800-1000 cc). Advised clinical correlation."
13.7.2017 Serum lipase value was found to be highly increased (1686 units/litre against the normal value ofupto 60).
17.7.2017 Histopathological report of the gall bladder removed at surgery was-"Acute on chronic Cholecystitis".
2.8.2017 Again admitted in Jay Pee Hospital and discharged on 4.8.2017.
This complaint is bad for non-arraignment and mis-arraignment of parties. The Opposite Party No.1 is insured with "Oriental India Insurance Company Ltd.", through Professional Indemnity (Error and Omission) Policy No. 272200/48/2017/24164. Effective from 27/02/2017 to 26/02/2018. A separate application for impleading the said "Oriental India Insurance company Ltd.", is being filed herewith.
The opposite party no. 2 is insured with "the New India Assurance Company Limited", through its "Professional Indemnity" policy No. 32160036160400000063. Effective from 27/11/2016 to 26/11/2017. A separate application for impleading the said "oriental India insurance company Ltd.", is being filed herewith.
The Opposite Party No.1 & 2 are well qualified and a reputed doctors/hospitals, with substantial good will and experience of long standing successful medical practice. Copies of their dgrees, certificate etc. are enclosed.
Before adverting to the substance of the allegations of the complainant it is necessary to adumbrate the sequence of admitted events and the same are stated below to provide clarity on the present matter.
As per the complainant s own case, prior to 06.07.2017, the complainant visited Opposite parties no.1 and 2 complaining of on and off abdomen pain since the past one year and was prescribed ultra sound (and Blood Tests, X-ray EKG) and it was on the basis of this ultra sound report that she was advised the procedure (Para 4 of the complaint) (No details have been provided regarding the ultra sound.) Firstly, the complainant has not placed on record the ultra sound report which led to the diagnosis for the procedure. This itself shows the conduct of the complainant in coming to this Hon ble Commission with unclean hands. Secondly, the complainant has not questioned the findings of the ultra sound which mandated the conduct of the procedure.
The Ultra sound report showed problems with the gall bladder of the complainant and showed that it was not functioning properly. It is very important to note that the complainant has not questioned this aspect in the present complaint that her gall bladder required removal.
The procedure, i.e. laparoscopic cholecystectomy, is a procedure in which the gallbladder is removed by laparoscopic techniques. Laparoscopic surgery also referred to as minimally invasive surgery describe the performance of surgical procedures with the assistance of a video camera and several thin instruments. The standard surgery to remove the gallbladder is called a cholecystectomy. In this kind of surgery, the gallbladder is removed openly via an incision made in the abdomen. A less invasive way to remove the gallbladder is called laparoscopic cholecystectomy. This surgery uses an instrument called the laparoscope to remove the gallbladder.
The benefits of minimally invasive or laparoscopic procedures include less post-operative discomfort since the incisions are much smaller, quicker recovery times, shorter hospitals stays, earlier return to full activities and much smaller scars. Furthermore, there may be less internal scarring when the procedures are performed in a minimally invasive fashion compared to standard open surgery.
As gallbladder removal is a major abdominal operation and a certain amount of postoperative pain occurs. Any surgery has potential complications, including incision bleeding, movement of surgical materials to other parts of the body, pain, or infection with or without a fever. Typically, it takes the body time to adjust to its new method of digesting fat. Some patients do develop longer-term side effects, usually caused by bile leaking into other organs or gallstones that were left behind in the bile ducts. In addition, there are digestive side effects plus gallbladder removal carries a small risk of various complications. These include, bile leakage, injury to bile duct in the course of removing gallbladder (this may need an additional operation to fix this), injury to surrounding structures, to nearby blood vessels, liver, intestines, blood clots, infection, bleeding (hemorrhage), anesthesia reactions, heart problems, et cetera. A study published in March, 2018 in the journal HPB found that among people who underwent gallbladder removal because of mild gallstone pancreatitis (inflamed pancreas), nearly 15 percent experienced an attack of pain in the area after the surgery and in some cases, pain may result from gallstones remaining in the bile ducts. Articles detailing the complications of laparoscopic cholecystectomy with an analysis laparoscopic operation.
All the risks pertaining to the procedure conducted by opposite party no.1 on 06.07.2017 on the complainant at opposite party no.1, i.e. Gargi Hospital (hereinafter "Hospital") were duly informed to the complainant as these risks are standard risks and are possible though not likely to occur when the procedure is typically conducted. A Signed copy of the consent form of the complainant where it is clearly stated that the risks associated with the procedure have been informed to the complainant.
The complainant was duly discharged from the hospital on 08.07.2017 and admittedly on the follow up visit on 10.07.2017 to opposite party no.2 at the hospital, when the complainant complained of abdomen pain and discomfort, a magnetic resonance cholangiopancreatography (hereinafter "MRCP") was advised at Deewan Diagnostics, Ghaziabad. The MRCP was done on 11.07.2017 and the MRCP report stated as under (at page 15 of the complaint) Short segment of narrowing is seen in proximal 1/3rd of common bile duct associated with mild adjacent free fluid extending with GB fossa, subhepatic and perihepatic space. Distal 2/3 of CBD is normal in caliber and signal intensity..." Report:
The report also mentioned Pancreas normal. Pancreatic duct normal. Liver normal, short segment of narrowing in upper 1/3rd of CBD advised : ERCP for further evaluation.
As pr MRCP Report, there was some mild fluid which was coming from the common bile duct of the complainant. The complainant was advised and referred to Fortis Hospital, Shalimar Bagh, Delhi on 12.7.2017 itself for Endoscopic Retrograde Cholangio-Pancreatography (ERCP). However, the ERCP procedure could be performed successfully and was to be repeated after a period of 3-4 days (Refer Report findings: Needle knife papillotomy done; guidewire could be negotiated into CBD).
It is important to note that the ERCP procedure was performed under the supervision of Dr. Arvind Khurana. It is further important to highlight that opposite party no.2 had no active role to play in the ERCP procedure which was administered on the complainant at Fortis SB. In light of the fact that the ERCP was not successful, and he blood test reports post ERCP showed increased levels of serum bilirubin, serum alkaline phosphates and serum lipase, and pancreas diffusely bulky and appears edematous, most likely pancreatitis, the complainant was immediately advised and referred to Jaypee Hospital, Noida on 13.7.2017 and thereafter, underwent Gastrointestinal Hepato-Pancreatico Billary surgery under the supervision of Dr. Rajesh Kapoor. Also, it is pertinent to note that opposite party no.2 did not administer the procedure at Jaype Hospital. In the discharge summary at Jaypee Hospital, it is clearly stated that the complainant had a history of biliary Peritonitis Nontraumatic perforation of the bile duct is a disease in which the extrahepatic duct or intrahepatic duct is perforated spontaneously without traumatic or iatrogenic injury.
In the light of the above admitted facts and in light of the law laid down by the Hon ble Supreme Court of India in 2010 (15) SCC 193, Senthil Scan Centre v. Shanthi Sridharan & arn., 2018(13) SCC 224, Bijoy Sinha Roy (Dead) by LR v. Biswanath Das & ors. and Civil Appeal no.3971 of 2011, judgment dated October 1, 2018: Dr. S.K. Jhunjhunwala v. Dhanwanti Kumar, 2018 SCC Online SC 1721 the parameter for medical negligence as under:
a. Expert evidence is to be tendered to show that the doctor in question was grossly negligent. Admittedly, there is nothing on record to show that opposite party no.2 was either negligent in advice or action.
b. Error of judgment or an accident is not proof of negligence. So long as the doctor follows a practice acceptable to the medical profession of the day, he cannot he held liable for negligence merely because a better alterative course was available. Admittedly, there was no negligence on part of the opposite party no.2. The complication in the case of the complainant could have been due to any reason. The complainant has not put anything on record to show that opposite party no.2 was negligent. At best, without admitting any wrong doing by opposite party no.2, the complainant s case can be for error of judgment or accident and even then no case has been made out by the complainant, both in terms of pleadings or documents placed on record. There is no medical opinion on record which states that opposite party no.2 acted negligently. Therefore, in absence of the other treating doctors involved, the case of negligence cannot be sustained against opposite parties no.1 & 2.
The complainant does not make out a case for medical negligence and as such the present complaint is misconceived and an abuse of the process of law. It is admitted that every complication is not negligence. It has been because of the proactive approach, timely interventions, direction, supervision, guidance and advise by opposite party no.2 that the life of the complainant has been saved. Further, opposite party no.2 is duly qualified in his field and has a degree in MBBS, MS (General and Laparoscopic Surgery). The opposite party no.2 has been practicing in Ghaziabad since 1985 and has done many operations in general surgery, laparotomy, appendix, hernia, gall bladder removal, hysterectomy, etc. and has never had any complaints till date. A general google search with opposite party no.2 will throw up good reviews and shows that opposite party no.2 is a well-respected name in Ghaziabad. Opposite party no.2 is an expert and does his job with complete honesty, integrity and sincerity.
As per research (Laparoscopic Cholecystectomy): an Indian experience of 1233 cases, it is widely accepted internationally that the post operative complications may arise based on Human anatomy, and it does not constitute or establish any negligence on part of performing surgeon).
Medical Facts- International Study:- As per various medical research conducted by various national and International Authorities like and as per official journal of International Hepato-Pancreato Biliary Association, America Hepato-Pancreato-Biliary Association and European-African Hepato-Pancreato-Biliary Association- Evan though laparoscopic cholecystectomy (LC) has become the customary method for treating gallstones, some incidents and complications appear rather more frequently than with the open technique. Several aspects of these complications and their treatment possibilities are analyzed. During the past decade it has become the procedure of choice in the surgical treatment of cholecystectomy. The operation is not completely risk-free, some incidents and complications being more frequent than with open cholecystectomy (OC). Hence, it remains the choice of patient to go for open cholecystectomy (OC) or laparoscopic cholecystectomy.
The risks and complications of LC, which are cited mostly in public domain, by various national and International studies, must not be under-rated. Laparoscopy is not easy for the surgeon, and one of the most frequent situations carrying an increased operative risk is acute cholecystitis. First, pericholecystitis modifies the local anatomy and increases the difficulty of indentifying the cystic pedicle and CBD. Because it is impossible to perform antegrade cholecystectomy in most such cases, there is a high risk of CBD injury. Second, the cleavage plane in the gallbladder bed is lost, and that makes it easy to penetrate the liver parenchyma during dissection of the gallbladder, thus creating the possibility of postoperative bile leak, haemorrhage and subhepatic abscess. Other situations associated with increased difficulty in cholecystectomy are a shrunken fibrotic gallbladder, cirrhosis (when a regenerating nodule extends into the gallbladder bed) and, in few cases, obesity if there is marked fatty infiltration of the cystic pedicle. Most of the factors responsible for post operative complications arrive from patient s body type, human anatomy and receptivity to the medicines, which are not known to the treating doctors beforehand.
The major problem related to LC are bile duct injury, haemorrhage and sub-hepatic abscess. Lesions of the extrahepatic bile ducts can occur at any level as follows. Detachment of the gallbladder may open any accessory bile duct present in the gallbladder bed and as per studies, it demonstrates presence in 3-5% of individuals. Accessory bile ducts were only recognized in some patients only after detachment of the gallbladder. After open cholecystectomy postoperative bile leak or choleperitoneum from cystic duct is rare, but these complications are more frequent in LC.
The most serious problem is an injury to the main bile duct. Although the differences are not statistically significant, this injury is more frequently seen in LC (1% of cases) than in open cholecystectomy (0.5% of cases).
The Haemorrhage/bile duct leakage from the gallbladder bed was encountered more frequently in acute cholecystitis, in patients with a shrunken fibrotic gallbladder and in cirrhotics. This are specifics related to patient s anatomy. Bile leakage and bleeding may determine subhepatic abscess formation. The clinical picture was manifest 7-10 days after operations performed for acute cholecystitis.
Given below are the salient points from the research article- "Laparoscopic cholecystectomy: an Indian experience of 1233 cases".
a- Patients and methods: This paper represents a retrospective review of 1233 patients who underwent LC at Government Medical College and Hospital, Chandigarh, India, over 4 years (1997-2000). The case files of all these patients were analyzed for patient particulars, intraoperative findings, reason for any open conversion, postoperative stay, and mortality.
b- Results: The overall conversion rate was 7.06% (87 patients). The commonest cause of conversion was a frozen Calot s triangle (52 patients), followed by injury to the common bile duct (8 patients). The average postoperative stay in successful LC was 1.32 days. The overall mortality rate was 0.16% (2 deaths). The quality of life after LC was good to excellent in more than 90% of patients.
c- Source: Department of Surgery, government Medical College and Hospital, Chandigarh, India.
Hence, it is widely accepted internationally, the post operative complications may arise based on Human anatomy, and it does not constitute or establish any negligence on part of performing surgeon.
It is submitted that the complainant had a history of gallbladder issues and therefore, the procedure was advised. It is pertinent to note that the complainant has not placed on record her prior medical history of the copy of the ultra sound which formed the basis for the advice regarding the conduct of the procedure.
The true facts are that laparoscopic cholecystectomy was done on 06/07/2017 diligently, prudently with due care and caution. Prior to surgery an informed consent was taken and patient party including patient was well informed about the pros and cons of the procedure along with possible complications that sometimes happen. Every complication is not negligence. Patient was discharged on 08.07.2017 in a stable condition. On 10.07.2017 in follow up visit patient complained of vague pain with distention of abdomen for which patient was immediately advised for MRCP. On 11.07.2017 MRCP done at Deewan diagnostics, Ghaziabad, and it showed gall bladder is not visualized. Short segment of narrowing is seen in proximal 1/3rd of common bile duct associated with mild adjacent free fluid extending with GB fossa, subheaptic and perihepatic space. Distal 2/3 of CBD is normal in caliber and signal intensity. Pancreatic duct is normal. Pancreas is normal in size, signal intensity and outline. Liver appears normal in size, shape, contours and signal intensity. Visualized abdominal viscera appears normal. Impression: Short segment of narrowing in upper 1/3rd of CBD. ADVISE: ERCP for further evaluation. Therefore, patient was immediately and timely advised for ERCP from Fortis hospital. On 12/07/2017, Papillotomy was done at Fortis hospital, Shalimar Bagh. Findings showed: Papilla-small, tight, edematous; CBD-normal in caliber, no stone seen; (?) Query on minor leak from cystic duct stump seen; needle knife papillotomy done; guidewire could not be negotiated into CBD; MPD normal; IMPRESSION: CBD leak, papillotomy done, medicines prescribed and advised immediate follow up in case of fever and advised repeat of procedure after 3-4 days in case of no improvement, The patient arrived at Gargi Hospital at 2.00 AM on 13/07/2017 with pain and swelling of abdomen. Again prompt action was taken.
Investigations were done through Ultra sound and blood tests. Post ERCP procedure done at Fortis SB, the complainant developed pancreatitis with moderate free fluid in peritoneal cavity. Ultrasound report revealed bulky/ edematous pancreas. Test findings post ERCP of Ultra sound and blood tests Pancreas is diffusedly bulky and appears edematous obscured by bowel gases-most likely pancreatitis. Chest: There is minimal mild right pleural effusion with basal lung atelectasis. Gall Bladder: Surgically removed. CBD is normal in course and caliber. The blood test reports showed increased serum lipase, Serum bilirubin and alkaline phosphatase. At 11.15 am on the same day of 13/07/2017, the patient was immediately advised and referred to Dr. Rajesh Kapoor, MS, MCH (GI Surgeon) in Jaypee hospital, Noida. Pertinent to mention here that the complainant has not placed on record the timely interventions done by opposite parties no.1 & 2 at Gargi Hospital. There was absolutely no delay or wrong intention on the part of the opposite parties no.1 &2 as the procedure was done at other institutes by other doctors and the said doctors/institutes have not been made a party to the present proceeding therefore, the present complaint is liable to be rejected. The complainant developed pancreatitis following ERCP, which is a known complication. Pancreatitis is not the direct complication of laparoscopic cholecystectomy. Patient spent money for getting treatment of her own illness which was not caused by opposite party no.2. No doctor anywhere said that there was any negligence on the part of opposite party no.2. In fact, the timely interventions have actually led to the patient s complaints being addressed well on time and have saved the life of the patient.
It is pertinent to note here that the documents attached with the complaint do not match the expenditure claimed to have been spent by the complainant.
There is no proven negligence, deceptive practices, deficiency of service or unfair trade practice in the part of the opposite parties no.1 & 2. Therefore, not liable to pay anything to the patient party. The complainant is not entitled to get any alleged amount of compensation in view of the facts and circumstances of the case. The opposite parties no.1 & 2 operated diligently, prudently, with utmost due care and caution. Hence, the opposite parties no.1 &2 is not liable to pay any compensation to the complainant, as there is no deficiency of service and no medical negligence on the opposite parties no.1 & 2 parts.
There are number of discrepancies in the bills submitted. Firstly, the total amount of the bills submitted is Rs.6,05,999.00 out of one bill entry is in the name of Mrs. Deepika Singh, which is not the name of the complainant. Secondly, three entries are repeated. Thirdly, on bill for Rs.3,37,424.00 has three different entries in admission and discharge dates. The covering letter mentions admission date to Jaypee Hospital as 2.8.2017 and discharge date as 4.8.2017. The discharge summary mentions admission date as 2.8.2017 and discharge date as 3.8.2017. The final bill mentions the dates from 2.8.2017 to 18.8.2017. Further, the complainant has not disclosed whether any insurance amount was claimed by her.
Therefore, it is prayed that the complaint may kindly be dismissed with costs in the interest of natural justice. The complainant be ordered by this Hon ble Commission to pay Rs.10,000.00 under section 26 of the Consumer Protection Act, 1986 for filing vexatious complaint.
We have heard ld. Counsel for the complainant Sri Pratush Tripathi and ld. Counsel for the opposite parties Sri kamal Kumar Singh Visht and perused the entire record.
The complainant has stated that she visited opposite party no 2 for the treatment of her abdominal pain and on the prescription of the opposite party she got ultrasound examination and on the basis of this ultrasound report the opposite party suggested for Laparoscopy Cholecystectomy. The opposite parties in their written statement has mentioned the facts in short. According to them, the complainant visited opposite parties hospital on 05.07.2017 and Laparoscopic Cholecystectomy was done after planning written consent on 06.07.2017 after explaining in detail various possible complications. The opposite parties directed the component to undergo Ultrasound, blood tests, x-ray and EKG. According to the opposite parties this Laparoscopic Cholecystectomy was done on the basis of ultrasound report. The opposite party says that the complainant has not placed on record the ultrasound report which led to the diagnosis for the procedure. It is really strange that this Laparoscopic cholecystectomy That was done on the basis of the ultrasound report and now the opposite party says that the complainant has not filed the ultrasound report. When the opposite party received the ultrasound report and other blood test report, x-ray report and EKG, it was the duty to place these reports with the case history sheet of the patient. The diagnose on the basis of ultrasound report and now in their statement they have stated that the complainant has not placed on record the ultrasound report. It is unbelievable. This shows the negligence from the very beginning because it was the duty to place all the pathological tests report with them in the file of the patient. It is called deficiency in service.
Let us see, what happens in Laparoscopic Cholecystectomy.
Laproscopic Cholecystectomy Overview A cholecystectomy (koh-luh-sis-TEK-tuh-me) is a surgical procedure to remove your gallbladder -- a pear-shaped organ that sits just below your liver on the upper right side of your abdomen. Your gallbladder collects and stores bile- a digestive fluid produced in your liver.
A cholecystectomy is a common surgery, and it carries only a small risk of complications. In most cases, you can go home the same day of your cholecystectomy.
A cholecystectomy is most commonly performed by inserting a tiny video camera and special surgical tools through four small incisions to see inside your abdomen and remove the gallbladder. Doctors call this a laparoscopic cholecystectomy.
In some cases, one large incision may be used to remove the gallbladder. This is called an open cholecystectomy.
Why it s done GallstonesEnlarge image A cholecystectomy is most commonly performed to treat gallstones and the complications they cause. Your doctor may recommend a cholecystectomy if you have:
• Gallstones in the gallbladder (cholelithiasis) • Gallstones in the bile duct (choledocholithiasis) • Gallbladder inflammation (cholecystitis) • Large gallbladder polyps • Pancreas inflammation (pancreatitis) due to gallstones Risks A cholecystectomy carries a small risk of complications including:
• Bile leak • Bleeding • Infection • Injury to nearby structures, such as the bile duct, liver and small intestine • Risks of general anesthesia, such as blood clots and pneumonia Your risk of complications depends on your overall health and the reason for your cholecystectomy.
How you prepare Food and medications To prepare for a cholecystectomy, your surgeon may ask you to:
• Eat nothing the night before your surgery. You may drink a sip of water with your medications, but avoid eating and drinking at least four hours before your surgery.
• Stop taking certain medications and supplements. Tell your doctor about all the medications and supplements you take. Continue taking most medications as prescribed. Your doctor may ask you to stop taking certain medications and supplements because they may increase your risk of bleeding.
Clothing and personal items Most people go home the same day of their cholecystectomy, but complications can occur that require one or more nights in the hospital. Plan ahead in case you need to stay in the hospital by bringing personal items, such as your toothbrush, comfortable clothing, and books or magazines to pass the time.
Other precautions Find someone to drive you home and stay with you. Ask a friend or family member to drive you home and stay close the first night after surgery.
What you can expect Before the procedure A cholecystectomy is performed using general anesthesia, so you won t be aware during the procedure. Anesthesia drugs are given through a vein in your arm. Once the drugs take effect, your health care team will insert a tube down your throat to help you breathe. Your surgeon then performs the cholecystectomy using either a laparoscopic or open procedure.
During the procedure Depending on your situation, your surgeon will recommend one of two surgical approaches:
Minimally invasive (laparoscopic) cholecystectomy During a laparoscopic cholecystectomy, the surgeon makes four small incisions in your abdomen. A tube with a tiny video camera is inserted into your abdomen through one of the incisions. Your surgeon watches a video monitor in the operating room while using surgical tools inserted through the other incisions in your abdomen to remove your gallbladder.
Next you may undergo an imaging test, such as an X-ray or ultrasound, if your surgeon is concerned about possible gallstones or other problems in your bile duct. Then your incisions are sutured, and you re taken to a recovery area. A laparoscopic cholecystectomy takes one or two hours.
A laparoscopic cholecystectomy isn t appropriate for everyone. In some cases your surgeon may begin with a laparoscopic approach and find it necessary to make a larger incision because of scar tissue from previous operations or complications.
Traditional (open) cholecystectomy During an open cholecystectomy, the surgeon makes a 6-inch (15-centimeter) incision in your abdomen below your ribs on your right side. The muscle and tissue are pulled back to reveal your liver and gallbladder. Your surgeon then removes the gallbladder.
The incision is sutured, and you re taken to a recovery area. An open cholecystectomy takes one or two hours.
After the procedure You ll be taken to a recovery area as the anesthesia drugs wear off. Then you ll be taken to a hospital room to continue recovery. Recovery varies depending on your procedure:
• Laparoscopic cholecystectomy. People are often able to go home the same day as their surgery, though sometimes a one-night stay in the hospital is needed. In general, you can expect to go home once you re able to eat and drink without pain and are able to walk unaided. It takes about a week to fully recover.
• Open cholecystectomy. Expect to spend two or three days in the hospital recovering. Once at home, it may take four to six weeks to fully recover.
Results A cholecystectomy can relieve the pain and discomfort of gallstones. Conservative treatments, such as dietary modifications, usually can t stop gallstones from recurring. In most cases, a cholecystectomy will prevent gallstones from coming back.
Most people won t experience digestive problems after a cholecystectomy. Your gallbladder isn t essential to healthy digestion. Some people may experience occasional loose stool after the procedure, which generally resolves over time. Discuss with your doctor any changes in your bowel habits or new symptoms following your procedure.
How quickly you can return to normal activities after a cholecystectomy depends on which procedure your surgeon uses and your overall health. People undergoing a laparoscopic cholecystectomy may be able to go back to work in a matter of days. Those undergoing an open cholecystectomy may need a week or more to recover enough to return to work.
Clinical trials Explore Mayo Clinic studies of tests and procedures to help prevent, detect, treat or manage conditions.
Complications-Gallbladder removal Contents
1. Overview
2. What happens
3. Recovery
4. Complications Removal of the gallbladder (cholecystectomy) is considered a relatively safe procedure, but like all operations there s a small risk of complications.
Infection Some people develop a wound or internal infection after a gallbladder removal.
Signs of a possible infection include increasing pain, swelling or redness, and pus leaking from a wound.
See your GP if you develop these symptoms, as you may need a short course of antibiotics.
Bleeding Bleeding can occur after your operation, although this is rare. If it does occur, you may require a further operation to stop it.
Bile leakage When the gallbladder is removed, special clips are used to seal the tube that connects the gallbladder to the main bile duct.
But bile fluid can occasionally leak out into the tummy (abdomen) after the gallbladder is removed.
Symptoms of a bile leak include tummy pain, feeling sick, a fever and a swollen tummy.
Sometimes this fluid can be drained off. Occasionally, an operation is required to drain the bile and wash out the inside of your tummy.
Bile leakage occurs in around 1% of cases.
Injury to the bile duct The bile duct can be damaged during a gallbladder removal.
If this happens during surgery, it may be possible to repair it straight away.
In some cases, further surgery is needed after your original operation.
Injury to the intestine, bowel and blood vessels The surgical instruments used to remove the gallbladder can also injure surrounding structures, such as the intestine, bowel and blood vessels.
This type of injury is rare and can usually be repaired at the time of the operation.
Sometimes injuries are noticed afterwards and a further operation is needed.
Deep vein thrombosis Some people are at a higher risk of blood clots developing after surgery.
This is known as deep vein thrombosis (DVT) and usually occurs in a leg vein.
This can be serious because the clot can travel around the body and could block the flow of blood into the lungs (pulmonary embolism).
You may be given special compression stockings to wear after the operation to prevent this happening.
Risks from general anaesthetic There are several serious complications associated with having a general anaesthetic, but these are very rare.
Complications include allergic reaction and death. Being fit and healthy before your operation reduces the risk of any complications occurring.
Post-cholecystectomy syndrome Some people experience symptoms similar to those caused by gallstones after surgery, including:
• tummy pain • indigestion • diarrhoea • yellowing of the eyes and skin (jaundice) • a high temperature (fever) This is known as post-cholecystectomy syndrome (PCS). It s thought to be caused by bile leaking into areas such as the stomach, or by gallstones being left in the bile ducts.
In most cases symptoms are mild and short-lived, but they can persist for many months.
If you have persistent symptoms, you should contact your GP for advice.
You may benefit from a procedure to remove any remaining gallstones, or medication to relieve your symptoms.
It is on the doctor to decide whether laparoscopic cholecystectomy or open cholecystectomy is beneficial for the patient. It depends on the condition and ailment and body physique of the patient. If there is doubt that bile duct may be punctured or something else, it is better to go for open surgery and not laparoscopic surgery.
For laparoscopic cholecystectomy you need consent for the Laparoscopic Cholecystectomy and also consent for the administration of anaesthesia. These are the first two important steps before going for operation. First we are reproducing the consent form as filled by the complainant attendant (husband). This consent form is a printed form in which consent has been taken for all the operation in a single consent form. The surgeon name has been mentioned as Dr. Ajit Kpoor and name of the anaesthetist as Dr. Indu Yadav. So for the operation and for the anaesthesia, common consent form has been taken by the concerned Dr from husband of the patient. This consent form is scanned and reproduced here for ready reference.
We have seen an article regarding consent and consent form and how it is to be taken from the patient or patient s family/attendants.
Consent and the Indian medical practitioner Consent is a legal requirement of medical practice and not a procedural formality. Getting a mere signature on a form is no consent. If a patient is rushed into signing consent, without giving sufficient information, the consent may be invalid, despite the signature. Often medical professionals either ignore or are ignorant of the requirements of a valid consent and its legal implications. Instances where either consent was not taken or when an invalid consent was obtained have been a subject matter of judicial scrutiny in several medical malpractice cases. This article highlights the essential principles of consent and the Indian law related to it along with some citations, so that medical practitioners are not only able to safeguard themselves against litigations and unnecessary harassment but can act rightfully.
INTRODUCTION Legally, two or more persons are said to consent when they agree upon the same thing in the same sense.[1] Consent must be obtained prior to conducting any medical procedure on a patient. It may be expressed or implied by patient s demeanour. A patient who comes to a doctor for treatment implies that he is agreeable to general physical (not intimate) examination.[2] Express consent (verbal/written) is specifically stated by the patient. Express verbal consent may be obtained for relatively minor examinations or procedures, in the presence of a witness.[3] Express written consent must be obtained for all major diagnostic, anaesthesia and surgical procedures as it is the most undisputable form of consent.
ESSENTIAL PRINCIPLES OF A VALID CONSENT AND THE INDIAN LAW A doctor must take the consent of the patient before commencing a treatment/procedure except in emergencies, informed consent should be obtained sometime prior to the procedure so that the patient does not feel pressurised or rushed to sign. On the day of surgery, the patient may be under extreme mental stress or under influence of pre-medicant drugs which may hamper his decision-making ability. Consent remains valid for an indefinite period, provided there is no change in patient condition or proposed intervention.[4] It should be confirmed at the time of surgery.[4] Consent must be taken from the patient himself.
The doctor before performing any procedure must obtain patient s consent.[5] No one can consent on behalf of a competent adult. In Dr. Ramcharan Thiagarajan Facs versus Medical Council of India case,[6] disciplinary action was awarded to the surgeon for not taking a proper informed consent for the entire procedure of kidney and pancreas transplant surgery from the patient. In some situations, beside patient consent, it is desirable to take additional consent of spouse. In sterilisation procedures, according to the Ministry of Health and Family Welfare, Government of India guidelines, consent of spouse is not required.[7] The Medical Council of India (clause 7.16) however states that in case an operation carries the risk of sterility, the consent of both husband and wife is needed.[8] It is advisable to take consent of spouse when the treatment or procedure may adversely affect or limit sex functions, or result in death of an unborn child.[9] In case of minor, consent of person with parental responsibility should be taken.[10] In an emergency, the person in charge of the child at that time can consent in absence of parents or guardians (loco parentis).[11] In a medical emergency, life-saving treatment can be given even in absence of consent.
Refusing treatment in life-threatening situations due to non-availability of consent may hold the doctor guilty, unless there is a documented refusal to treatment by the patient. In Dr. TT Thomas versus Smt. Elisa and Orscase,[12] the doctor was held guilty of negligence for not operating on a patient with life-threatening emergency condition, as there was no documented refusal to treatment.
The patient should have the capacity and competence to consent.
A person is competent to contract[13] if (i) he has attained the age of majority,[14] (ii) is of sound mind[15] and (iii) is not disqualified from contracting by any law to which he is subject. The legal age for giving a valid consent in India is 18 years.[14] A child 12 years can give a valid consent for physical/medical examination (Indian Penal Code, section 89).[3] Prior to performing any procedure on a child 18 years, it is advisable to take consent of a person with parental responsibility so that its validity is not questioned. If patient is incompetent, then consent can be taken from a surrogate/proxy decision maker who is the next of kin (spouse/adult child/parent/sibling/lawful guardian).[11] Consent should be free and voluntary.
Consent is said to be free[16] when it is not caused by coercion,[17] undue influence,[18] fraud,[19] misrepresentation,[20] or mistake.[21,22,23] Consent should be informed.
Consent should be on the basis of adequate information concerning the nature of the treatment procedure.[5] Consent should be informed and based on intelligent understanding. The doctor must disclose information regarding patient condition, prognosis, treatment benefits, adverse effects, available alternatives, risk of refusing treatment and the approximate treatment cost. He should encourage questions and answer all queries.[2] If the possibility of a risk, including the risk of death, due to performance of a procedure or its refusal is remote or only theoretical, it need not be explained.[5] Exceptions to physician s duty to disclose include[24] : (i) Patient refusal to be informed; this should be documented. (ii) If the doctor feels that providing information to a patient who is anxious or disturbed would not be processed rationally by him and is likely to psychologically harm him, the information may be withheld from him (therapeutic privilege); he should then communicate with patient s close relative, family doctor or both.
The "adequate information" must be furnished by the doctor (or a member of his team) who treats the patient.[5] Information imparted should enable the patient to make a balanced judgment as to whether he should submit himself to the particular treatment or not.[5] Consent should be procedure specific.
Consent given only for a diagnostic procedure, cannot be considered as consent for the therapeutic treatment.[5] Consent given for a specific treatment procedure will not be valid for conducting some other procedure.[5] In Samira Kohli versus Dr. Prabha Manchanda and Anr case,[5] the doctor was held negligent for performing an additional procedure on the patient without taking her prior consent. An additional procedure may be performed without consent only if it is necessary to save the life or preserve the health of the patient and it would be unreasonable to delay, until patient regains consciousness and takes a decision.[5] A common consent for diagnostic and operative procedures may be taken where they are contemplated.[5] Consent obtained during the course of surgery is not acceptable.
In Dr. Janaki S. Kumar and Anr. versus Mrs. Sarafunnisa case, [25] in an allegation of performing sterilisation without consent, it was contended that consent was obtained during the course of surgery. The commission held that the patient under anaesthesia could neither understand the risk involved nor could she give a valid consent.
Consent for blood transfusion.
When blood transfusion is anticipated, a specific written consent should be taken,[24] exception being an emergency situation where blood transfusion is needed to save life and consent cannot be attempted.[26] In M. Chinnaiyan versus Sri. Gokulam Hospital and Anrcase,[27] court awarded compensation as patient was transfused blood in the absence of specific consent for blood transfusion.
Consent for examining or observing a patient for educational purpose Prior to examining or observing patients for educational purpose, their consent must be taken.[28] Blanket consent is not valid.
Consent should be procedure specific. An all-encompassing consent to the effect I authorize so and so to carry out any test/procedure/surgery in the course of my treatment is not valid.[29] Fresh consent should be taken for a repeat procedure.
A fresh written informed consent must be obtained prior to every surgical procedure that includes re-exploration procedure. In Dr. Shailesh Shah versus Aphraim Jayanand Rathod case,[30] the surgeon was found deficient in service and was liable for compensation as he had performed a re-exploration surgery without a written consent from the patient.
Surgical consent is not sufficient to cover anaesthesia care.
The surgeons are incapable to discuss the risks associated with anaesthesia. Informed consent for anaesthesia must be taken by the anaesthesia provider as only he can impart anaesthesia related necessary information and explain the risks involved. It may be documented by the anaesthesiologist on the surgical consent form by a handwritten note, or on a separate anaesthesia consent form.[31] Patient has the right to refuse treatment.
Competent patients have the legal and moral right to refuse treatment, even in life-threatening emergency situations.[31] In such cases informed refusal must be obtained and documented, over the patient s witnessed signature.[32] It may be advisable that two doctors document the reason for non-performance of life-saving surgery or treatment as express refusal by the patient or the authorised representative and inform the hospital administrator about the same.
To detain an adult patient against his will in a hospital is unlawful.[9] If a patient demands discharge from hospital against medical advice, this should be recorded, and his signature obtained.[9] Unilaterally executed consents are void.
Consent signed only by the patient and not by the doctor is not valid.[33] Witnessed consents are legally more dependable.
The role of a witness is even more important in instances when the patient is illiterate, and one needs to take his/her thumb impression.[34] Consent should be properly documented Video-recording of the informed consent process may also be done but with a prior consent for the same. This should be documented. It is commonly done for organ transplant procedures. If consent form is not signed by the patient or is amended without his signed authorisation, it can be claimed that the procedure was not consented to.[10] Patient is free to withdraw his consent anytime.
When consent is withdrawn during the performance of a procedure, the procedure should be stopped. The doctor may address to patient s concerns and may continue the treatment only if the patient agrees. If stopping a procedure at that point puts patient s life in danger, the doctor may continue with the procedure till such a risk no longer exists.[10] Consent for illegal procedures is invalid.
There can be no valid consent for operations or procedures which are illegal.[24] Consent for an illegal act such as criminal abortion is invalid.[9] Consent is no defence in cases of professional negligence.[9] HOW TO OBTAIN A VALID CONSENT AND CONSENT FORMAT.
Always maintain good communication with your patient and provide adequate information to enable him make a rational decision.[35] It is preferable to take consent in patient s vernacular language. It may be better to make him write down his consent in the presence of a witness.[34] It is desirable to use short and simple sentences and non-medical terminology that is written/typed legibly.[36] Patient information sheets (PIS) depicting procedure related information, including pre-operative and post-operative pre-cautions in patient s understandable local language with pictorial representation may facilitate the informed consent process. These may help in providing consistently accurate information to the patients.[35] PIS should be handed over to the patients after explaining the contents. Even videos may be used as an aid in increasing patient understanding.[37] Though there is no standard consent format, it may include the following [e.g., Figure 1]:[38] Figure 1 Anaesthesia informed consent form • Date and time • Patient related: Name, age and signature of the patient/proxy decision maker • Doctor related: Name, registration number and signature of the doctor • Witness: Name and signature of witness • Disease-related: Diagnosis along with co-morbidities if any • Surgical procedure related: Type of surgery (elective/emergency), nature of surgery with antecedent risks and benefits, alternative treatment available, adverse consequences of refusing treatment • Anaesthesia related: Type of anaesthesia (general and/or regional, local anaesthesia, sedation) including risks • Blood transfusion: Requirement and related risks • Special risks: Need for post-operative ventilation, intensive care, etc • Document the fact that patient and relatives were allowed to ask questions, and their queries were answered to their satisfaction.
CONSENT IN RELATION TO PUBLICATION.
A registered medical practitioner is not permitted to publish photographs or case reports of his/her patients without their consent, in any medical or another journal in a manner by which their identity could be revealed. However, in case the identity is not disclosed, consent is not needed (clause 7.17).[8] CONSENT IN RELATION TO MEDICAL RESEARCH Consent taken from the patient for the drug trial or research should be as per the Indian Council of Medical Research guidelines[39]; otherwise it shall be construed as misconduct (clause 7.22).[8] COMMON FALLACIES IN THE CONSENT PROCESS.
The anaesthesiologist must ensure that consent is given maximum importance, and all the legal formalities are followed before agreeing to provide the services. Following are some frequent mistakes and omissions that can cost him/her dearly in the event of a mishap: Procedure is considered trivial, and consent is not taken.
• Consent of relative is taken instead of the patient, even when patient is a competent adult.
• Consenting person is minor, intoxicated or of unsound mind • Blanket consent is taken.
• It is not procedure specific • Consent for blood transfusion is not obtained.
• Fresh consent is not taken for a repeat procedure • Procedure related necessary information is not given • Even if the information given, it is not documented • Consent lacks the signature of the treating doctor • Consent is not witnessed • Alterations or additions are made in the consent form without patient s signed authorisation.
SUMMARY It is not only ethical to impart correct and necessary information to a patient prior to conducting any medical procedure, but it is also important legally. This communication should be documented. Even professional indemnity insurance may not cover for lapses in obtaining a valid consent, considering it to be an intentional assault.
ACKNOWLEDGMENTS We gratefully acknowledge the invaluable contribution and irreplaceable advice extended to us during the preparation of this article by Mr. M Wadhwani, Advocate.
[ REFERENCES
1. Indian Contract Act, Sec 13; 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act,1872.-2386 .
2. Sharma G, Tandon V, Chandra PS. Legal sanctity of consent for surgical procedures in India. Indian J Neurosurg. 2012;1:139-43. [Google Scholar]
3. Rao NG. Textbook of Forensic Medicine and Toxicology. 2nd ed. New Delhi: Jaypee Brothers Medical Publishers (P) Ltd.; 2010. Ethics of medical practice; pp. 23-44. [Google Scholar]
4. Anderson OA, Wearne IM. Informed consent for elective surgery - what is best practice? J R Soc Med. 2007;100:97-100. [PMC free article] [PubMed] [Google Scholar]
5. Samira Kohli vs. Dr. Prabha Manchanda and Anr on 16 January, 2008. Civil Appeal No. 1949 of 2004. (2008) 2 SCC 1; AIR 2008 SC 1385. [Accessed on 2014 May 9]. Available from: http://www.indiankanoon.org/doc/438423/
6. Dr. Ramcharan Thiagarajan Facs vs Medical Council of India on 3 April, 2014. Karnataka High Court. Writ Petition No. 11207/2013 (GM-RES) [Accessed on 2014 July 11]. Available from: http://www.indiankanoon.com/doc/10293098/
7. Standards for Female Sterilization (1.4.4), Standards for Male Sterilization (2.4.4) Standards for Female and Male Sterilization Services. Research Studies and Standards Division, Ministry of Health and Family Welfare Government of India. 2006. Oct, [Accessed on 2014 Mar 16]. Available from: http://www.nrhmtn.gov.in/modules/Guidelines%20for%20Standard%20for%20 female%20 & %20 male%20sterilization%20services.pdf .
8. Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002. Published in Part-III, Section 4 of the Gazette of India, dated 6th April, 2002, Amended up to December. 2010.
9. Reddy KS, Murty OP. The Essentials of Forensic Medicine and Toxicology. 32nd ed. Hyderabad: K Suguna Devi; 2013. Medical law and ethics; pp. 22-55. [Google Scholar]
10. Herring J. Medical Law and Ethics. 4th ed. United Kingdom: Oxford University Press; 2012. Consent to treatment; pp. 149-220. [Google Scholar]
11. Arora V. Role of consent in medical practice. [Accessed on 2014 Mar 21];JEvol Med Dent Sci 2013. 2:1225-9. Available from: http://www.jemds.com/data_pdf/vijay%20arora-ROLE%20OF%20CONSENT%20IN%20MEDICAL.pdf . [Google Scholar]
12. Dr. TT Thomas vs Smt Elisa and Ors on 11 August, 1986. Kerala High Court. AIR 1987 Ker 52: 1986 Ker LT 1026 (DB) [Accessed on 2014 Jun 2]. Available from: http://www.indiankanoon.org/doc/600254/
13. Indian Contract Act, Sec 11. 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act.,1872.-2384 .
14. Indian Majority Act. 1875. [Accessed on 2014 Aug 21]. Available from: http://admis.hp.nic.in/himpol/Citizen/LawLib/C0141.htm .
15. Indian Contract Act, Sec 12. 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act.,1872.-2385 .
16. The Indian Contract Act, Sec 14. 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act.,1872.-2387 .
17. The Indian Contract Act, Sec 15. 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act.,1872-2388 .
18. The Indian Contract Act, Sec 16. 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act.,1872-5173 .
19. The Indian Contract Act, Sec 17. 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act.,1872-2390 .
20. The Indian Contract Act, Sec 18. 1872. [Accessed on 2014 Aug 21]. Available from: http://indiankanoon.org/doc/1270593/
21. The Indian Contract Act, Sec 20. 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act.,1872-5178 .
22. The Indian Contract Act, Sec 21. 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act.,1872-2395 .
23. The Indian Contract Act, Sec 22. 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act.,1872-5180 .
24. Kannan JK, Mathiharan K. Legal and ethical aspects of medical practice. In: Modi A, editor. Textbook of Medical Jurisprudence and Toxicology. 24th ed. Nagpur: Lexis Nexis Butterworths Wadhwa; 2012. pp. 61-118. [Google Scholar]
25. Dr. Janaki S Kumar and Anr vs Mrs. Sarafunnisa on 21 June, 1999. Kerala State Consumer Disputes Redressal Commission, Thiruvananthapuram. Appeal No. 850 of 1998. (1999) I CPJ 66.
26. Kekre NS. Medical law and the physician. Indian J Urol. 2008;24:135-6. [PMC free article] [PubMed] [Google Scholar]
27. M. Chinnaiyan vs. Sri. Gokulam Hospital and Anr on 25 September, 2006. III (2007) CPJ 228 NC. [Accessed on 2014 Aug 21]. Available from: http://www.indiankanoon.org/doc/1919829/
28. Doyal L. Closing the gap between professional teaching and practice. BMJ. 2001;322:685. [PMC free article] [PubMed] [Google Scholar]
29. Satyanarayana Rao KH. Informed consent: An ethical obligation or legal compulsion? J CutanAesthet Surg. 2008;1:33-5. [PMC free article] [PubMed] [Google Scholar]
30. Dr Shailesh Shah vs AphraimJayanand Rathod. National Consumer Disputes Redressal Commission New Delhi, FA No. 597 of 1995. From the order dated 8 Nov, 1995 in complaint No. 31/94, State Commission Gujarat. [Last accessed on 2014 Aug 21]. Available from: http://www.ncdrc.nic.in/fa59795.html .
31. Waisel DB. Legal aspects of anesthesia care. In: Miller RD, Eriksson LI, Fleisher LA, Wiener-Kronish JP, Young WL, editors. Miller s Anesthesia. 7th ed. Philadelphia USA: Churchill Livingstone Elsevier; 2010. pp. 221-33. [Google Scholar]
32. Tewari A, Garg S. Informed consent and anaesthesia. Indian J Anaesth. 2003;47:311-2. [Google Scholar]
33. Bastia BK, Kuruvilla A, Saralaya KM. Validity of consent-A review of statutes. Indian J Med Sci. 2005;59:74-8. [PubMed] [Google Scholar]
34. Bastia BK. Consent to treatment: Practice vis-à-vis principle. Indian J Med Ethics. 2008;5:113-4. [PubMed] [Google Scholar]
35. Kalantri SP. Informed consent and the anaesthesiologist. Indian J Anaesth. 2003;47:94-6. [Google Scholar]
36. Kaushik JS, Narang M, Agarwal N. Informed consent in pediatric practice. Indian Pediatr. 2010;47:1039-46. [PubMed] [Google Scholar]
37. Tompsett E, Afifi R, Tawfeek S. Can video aids increase the validity of patient consent? J ObstetGynaecol. 2012;32:680-2. [PubMed] [Google Scholar]
38. Singh D. Singh D. Informed vs. Valid consent: Legislation and responsibilities. [Accessed on 2014 Aug 21];Indian J Neurotrauma. 2008 5:105-8. Available from: http://www.medind.nic.in/icf/t08/i2/icft08i2p105.pdf . [Google Scholar]
39. Ethical Guidelines for Biomedical Research on Human Participants. New Delhi: Published by: Director General Indian Council of Medical Research; 2006. [Accessed on 2014 Mar 3]. eral Ethical Issues; pp. 21-33. ] Now we discuss a little about consent form filed by the opposite parties with their written statement. First there is no signature of the concerned Dr on this consent form. There is no separate consent form for anaesthesia. This pro forma is not in accordance with the pro forma prescribed for taking the consent. There is no separate consent to use the body for post-mortem examination for the purpose of study. There is nothing in this consent form which shows that the doctor has specifically mentioned all the risks to the patient or his family members regarding operation or any other tests which may be performed. So this consent form is not a proper consent form as per the guidelines. There is no signature of any witnesses on this consent form. The most alarming fact is that, that no authorised person from the opposite parties side has put his signature on this consent form. There is only the signature of the husband of the patient. Whether the Dr mentioned all the risks and side effects of the operation and medicines to the patient is not clear ? So this consent form is taken in haste without seeing that nobody from the opposite parties side has put his signature on this consent form. It also shows deficiency and negligence on the part of the opposite parties.
The opposite party has stated that prior to surgery an informed consent was taken and patient party including patient was well informed about the pros and cons of the procedure along with possible complications that sometimes happen. Informed consent is generally used in the procedure of endoscopy but sometimes it may apply in laparoscopy also as clear from the following article.
Informed consent is necessary in good clinical practice. It is based on the patient´s ability to understand the information about the proposed procedure, the potential consequences and complications, and alternative options. The information is written in understandable language and is fortified by verbal discussion between physician and patient. The aim is to explain the problem, answer all questions and to ensure that the patient understands the problems and is able to make a decision. The theory is clear but what happens in daily practice?
INTRODUCTION There is a general consensus that every patient coming for digestive endoscopy has the right and should be informed in an adequate, appropriate and understandable way about the procedure. This information should be given in a timely fashion before the endoscopy and should provide a description of the test comprehensibly, explain the reason for investigation, the alternatives, possible risks and benefits, and main implications. It is mandatory to have time and the opportunity to ask additional questions. The decision to undergo endoscopy should not be made under duress and confirmed by the patient s signature on a written form of informed consent. Thus, everything is clear. However, daily routine practice is a little bit more complicated.
PATIENTS AND METHODS According to a survey of the European Society of Gastrointestinal Endoscopy (ESGE) in 2002[1], the procedure for obtaining informed consent for digestive endoscopy varies considerably. A structured questionnaire regarding the quality of informed consent was sent to particular endoscopic societies that are members of the ESGE. The response rate was 59% (26/44). The required information is given prior to written consent in only 23% (6/26) of the countries. Information about the procedure is given to the patients in 96% of the responding countries and in only 77% is there sufficient time for patients to ask questions about the nature of the test. In 15% (4/26) of the countries, neither diagnostic nor therapeutic alternatives to endoscopy or the potential complication rate are discussed[1]. Other published data available is rather controversial. Several studies had different experiences. For instance, in one survey, 92% of patients were properly informed[2], while according to others, 51% felt dissatisfied because they would have wanted more information (before diagnostic endoscopy) and 25% to 76% had not been adequately informed about the potential risks (of diagnostic endoscopy or endoscopic retrograde cholangiopancreatography) and alternative methods (to percutaneous endoscopic gastrostomy)[3-5]. In a Veterans Administration study[6], all patients signed the consent form before sigmoidoscopy but only 14% of patients actually read all of it (most thought that they had enough information to proceed with the endoscopy). Most patients (93%) were given the opportunity to ask questions but only 22% actually did so[6]. Some gastroenterologists are afraid that patients undergoing open access endoscopy are less likely to be properly informed about their endoscopic procedure than the group of patients referred from specialized clinics[7]. Others propose to send information booklets or leaflets on endoscopy procedures in advance by post[8] or provide patients with information by means of computer-based visualization[9]. Despite all non-homogenous data, it is quite clear that informed consent is only one of the items of information needed by patients before digestive endoscopy.
However, some demands are difficult to meet. Mayberry[10] studied levels of information required by patients (516 persons contacted) and solicitors specializing in clinical negligence (79 subjects addressed) before gastroscopy and flexible sigmoidoscopy. Of the solicitors, 86% felt that patients needed to be informed about the procedure on at least two occasions and favored booklets and videos. Both 75% of solicitors and 44% of patients thought that informed consent for endoscopy should be obtained 2 wk before the test. Forty-eight percent of solicitors and 38% of patients felt that patients should be told of very uncommon risks (16% of solicitors even expected information about risks of 1 in 1 000 000)[10]. According to the British Society of Gastroenterology Guidelines for Informed Consent[3], the patient should be fully informed by the endoscopist ideally at least 24 h before the procedure; however, for busy units these are impossible standards[3].
A significant number of patients (41%) signing informed consent were worried by the explanation of the risks (before laparoscopy)[11].
Another study was carried out at the Inverclyde Royal Hospital, Greenock, Scotland. Demosthenous et al[12] used validated tests of memory on 59 patients undergoing lower limb arthroplasty to assess how well they learned and recalled information about their planned procedure. Neuropsychological tests were administered to measure the patient s ability to receive, store and recall information delivered verbally. All patients showed an ability to learn new material; however, younger age and higher educational achievement correlated with better performance (patients were excluded if they had any condition impairing memory or communication: dementia, cerebrovascular disease, epilepsy, head injury, dysphasia or aphasia). These results have serious implications for orthopedic surgeons discussing planned procedures. They identified groups of patients who may require enhanced methods of communicating the objectives, risks and alternatives to surgery.
One third of patients were distressed or surprised to be given oral or written information in a French study, obtaining informed consent for digestive endoscopy was distressing for 20% of those subjects[13]. In another French study[14], 10% of patients considered that the written consent for gastrointestinal endoscopy altered their trust in their endoscopist. Discussions of risk must especially be made in a friendly manner[15] and should not frighten the patient or even discourage him/her from undergoing the endoscopy.
Informed consent has been set within the framework of medical ethics. Whenever possible, patients should remain responsible for themselves. Where a choice of investigation/treatment might be reasonably offered, the physician may always advise the patient of his/her recommendation (together with reasons for such a suggestion). Clinicians must respect the need to maintain the autonomy and self-determination of patients[16]. Nevertheless, the question of protecting physicians from malpractice claims is a major aspect of the guidelines for informed consent of the British Society of Gastroenterology[16] and the American Society for Gastrointestinal Endoscopy[17].
It is questionable whether all endoscopy units working within particular societies of gastrointestinal endoscopy should use identical protocols of informed consent. For instance, the British Society of Gastroenterology[16] recommends that each unit should develop its own code of practice suitable to its mode of operation. However, some elements are universal and should always be included. The clinician proposing an endoscopic procedure should explain the reasons for the test and describe its essential elements[16,18]. Prior to the endoscopy, patients should be provided with written information in a timely fashion and in a form understandable to the patient[12,15].
The written information describes the principles of investigation and the reasons it is performed. It must list diagnostic/therapeutic alternatives to the test and explain possible major complications (in terms that the patient will understand). It is important to mention in writing that findings within endoscopy and/or possible complications may extend the investigation and/or change the treatment. It is mandatory to inform the patient about who has overall responsibility for the procedure and reassure him/her that the endoscopist and all the staff will do their best for the patient s benefit. A special part of informed consent should provide information about conscious sedation and its consequences (the patient will not be able to drive a vehicle, operate apparatus requiring full vigilance and must refrain from alcohol consumption for 24 h after the test). The patient must have an opportunity to ask additional questions. He/she must be also advised whom to contact in case of any complaint or complication after his/her discharge from the unit (including telephone number for consultation). A psychological approach to the patient is essential, including further clarification, reassurance and calming of any possible fears. Naturally, the form (appended with date, time and place) identifies not only the patient but also the unit and the responsible physician. After a full explanation and comprehension, the informed consent is signed by the patient and responsible physician. The form for informed consent should be prepared in duplicate, one for patient and one for medical records.
There are some special situations that should also be mentioned. The first one is "uninformed consent". Some patients agree with endoscopy but state that they do not wish to receive any information about the procedure and this should be respected. Ethically, information cannot be forced on them but their uninformed consent would still be valid if they are offered detailed information and if they understand that such information is available for them[18]. Parents (or guardians) will give (and sign) informed consent on behalf of their children and guardians (or first-degree relatives) on behalf of mentally disabled patients[18]. Special endoscopic procedures (insertion of esophageal or biliary stents and percutaneous endoscopic gastrostomy placement) should also be discussed in detail, including matters of long-term management and potential problems. Some of these patients are in a serious condition and their capacity to give consent may vary due to cerebral dysfunction. Consent may be possible orally or by gesture alone but since gastrostomy placement is an invasive procedure, a reasonable degree of certainty that the patient has consented plus discussion with relatives is needed in every case[16]. Since informed consent is a process and not a single event, post procedural follow-up of patients is obligatory[18]. In cases of an emergency (when the situation is life threatening or it is necessary to relieve severe pain and suffering), no consent is necessary, the endoscopist takes full responsibility and acts in the patient s best interest[16,18]. The understanding of the risks of endoscopy is insufficient, especially in the cases of older, poorly educated patients and outpatients[19]. It is also very important to respect a language barrier[20].
Technological progress has recently brought a lot of new endoscopic methods and devices. The 21th century especially has enriched gastroenterology with new great possibilities: balloon or deep enteroscopy, capsule enteroscopy, confocal laser endomicroscopy, biodegradable stents etc. Some of new endoscopic methods are still under evaluation and their yield and safety aspects must be further determined. These facts must be taken into account in the informed consent.
Lastly but not least, it is necessary to emphasize that the patient has a right to withdraw his/her previous consent at any time before or during the endoscopy. If the patient is under conscious sedation when requesting to end the procedure, the physician should make a judgement based on the best interests of the patient[18]. The Latin saying "salus aegroti suprema lex" (the patient s benefit is the highest law) must not be forgotten at any time.
CONCLUSION Informed consent is only one of the items of information needed by patients before digestive endoscopy. It is mandatory to give the patient time and the opportunity to ask additional questions. The clinician proposing an endoscopic procedure should explain the reasons for the test and describe its essential elements. Prior to the endoscopy, patients should be provided with written information in a timely fashion and in a form understandable to the patient. It is necessary to emphasize that the patient has a right to withdraw his/her previous consent at any time before or during the endoscopy.
Movement away from "informed consent" towards an "informed decision" would be the target we should reach in the near future.
References
1. Triantafyllou K, Stanciu C, Kruse A, Malfertheiner P, Axon A, Ladas SD. European Society of Gastrointestinal Endoscopy. Informed consent for gastrointestinal endoscopy: a 2002 ESGE survey. Dig Dis. 2002;20:280-283.
2. Manthous CA, DeGirolamo A, Haddad C, Amoateng-Adjepong Y. Informed consent for medical procedures: local and national practices. Chest. 2003;124:1978-1984.
3. Bassi A, Brown E, Kapoor N, Bodger K. Dissatisfaction with consent for diagnostic gastrointestinal endoscopy. Dig Dis. 2002;20:275-279.
4. Ladas SD, Triantafyllou K, Liappas I, Hatziargyriou M, Tzavellas E, Barbatzas C, Christodoulou G, Raptis SA. Percutaneous endoscopic gastrostomy: adequacy and quality of information given to decision makers. Dig Dis. 2002;20:289-292.
5. O Sullivan S, Crippen C, Ponich T. Are patients informed when they consent to ERCP? Can J Gastroenterol. 2002;16:154-158.
6. Basson MD, Gomez R, Fishman L, Panzini L. Informed consent for screening sigmoidoscopy in a Veterans Administration population. Dis Colon Rectum. 2004;47:1939-1946.
7. Staff DM, Saeian K, Rochling F, Narayanan S, Kern M, Shaker R, Hogan WJ. Does open access endoscopy close the door to an adequately informed patient? Gastrointest Endosc. 2000;52:212-217.
8. Shepherd HA, Bowman D, Hancock B, Anglin J, Hewett D. Postal consent for upper gastrointestinal endoscopy. Gut. 2000;46:37-39.
9. Enzenhofer M, Bludau HB, Komm N, Wild B, Mueller K, Herzog W, Hochlehnert A. Improvement of the educational process by computer-based visualization of procedures: randomized controlled trial. J Med Internet Res. 2004;6:e16.
10. Mayberry MK, Mayberry JF. Towards better informed consent in endoscopy: a study of information and consent processes in gastroscopy and flexible sigmoidoscopy. Eur J Gastroenterol Hepatol. 2001;13:1467-1476.
11. Wijtenburg E, Navez B, Cambier E, Guiot P. Patient s opinion about written information before laparoscopy: a consecutive series of 100 cases. Acta Chir Belg. 2002;102:17-19.
12. Demosthenous N, St Mart JP, Jenkins P, Chappel A, Cheng K. Cognitive function in patients undergoing arthroplasty: the implications for informed consent. Adv Orthop. 2011;2011:346161.
13. Roque I, Hochain P, Merle V, Lerebours E, Hecketsweiler P, Ducrotte P. Assessment of the quality and psychological impact of information delivered using official consent forms in digestive endoscopy (in French) Gastroenterol Clin Biol. 2003;27:17-21.
14. Denis B, Bottlaender J, Goineau J, Peter A, Weiss AM. Informed consent for gastrointestinal endoscopy. A patient-opinion survey (in French) Gastroenterol Clin Biol. 2002;26:675-679.
15. Isaacs PE. What information should be given to patients undergoing therapeutic endoscopy? Dig Dis. 2002;20:226-229.
16. Guidelines for informed consent for endoscopic procedures. British Society of Gastroenterology, 1999. Available from: http://www.bsg.org.uk/clinical_prac/guidelines/ consent.htm.
17. American Society for Gastrointestinal Endoscopy. Informed consent for gastrointestinal endoscopy. Gastrointest Endosc. 1988;34:26S-27S.
18. Stanciu C, Novis B, Ladas S, Sommerville A, Zabovowski P, Isaacs P, Papatheodoridis G, James T. Recommendations of the ESGE workshop on Informed Consent for Digestive Endoscopy. First European Symposium on Ethics in Gastroenterology and Digestive Endoscopy, Kos, Greece, June 2003. Endoscopy. 2003;35:772-774.
19. Song JH, Yoon HS, Min BH, Lee JH, Kim YH, Chang DK, Son HJ, Rhee PL, Rhee JC, Kim JJ. Acceptance and Understanding of the Informed Consent Procedure Prior to Gastrointestinal Endoscopy by Patients: A Single-Center Experience in Korea. Korean J Intern Med. 2010;25:36-43.
20. Clark S, Mangram A, Ernest D, Lebron R, Peralta L. The informed consent: a study of the efficacy of informed consents and the associated role of language barriers. J Surg Educ. 2011;68:143-147.
Therefore in this case the consent was not a proper consent and there is no proof regarding disclosure of all the risks to the patient before laparoscopy. We have already discussed it. Regarding informed consent it has also been discussed in the above-mentioned article. In laparoscopy anaesthesia is given so here written consent was necessary and also all the risks and consequences should have been mentioned in writing to the patient or his attendants. This lacuna is there in this case.
The opposite parties have filed a certificate regarding Master of surgery degree of the doctor Ajit Kapoor . We have seen it and found it is for general surgery issued on January 1984. Whether the doctor has taken any foundation course or any diploma or any special course regarding Laparoscopic Cholecystectomy and Laparoscopic Hysterectomy? The first laparoscopic cholecystectomy in India was performed in 1990 at the JJ Hospital, Mumbai, followed a few months later in Pune by Dr. Jyotsna Kulkarni. J. Barry McKernan and William B. Saye performed the first laparoscopic cholecystectomy in the United States on June 22, 1988 in Marietta, Georgia. In performing their very first laparoscopic cholecystectomy, Saye sutured the cystic duct and artery. So it is a new device or branch and the general surgeon has power to do this but as it is a new technique, there should be some guidelines are short-term course to perform this procedure. It is not clear that in this case whether the Dr has taken any such course of laparoscopic cholecystectomy?
The relation between doctor and patient is very delicate and it is the duty of the doctor to tell all the facts regarding the disease or ailment of the patient either to the patient or to his attendant.
First of all we have to see the doctor - patient relationship (DPR). This relationship is very important for all types of treatment of a patient by a doctor.
"Medicine is an art whose magic and creative ability have long been recognized as residing in the interpersonal aspects of patient-physician relationship."
Hall et al.,1981 A doctor-patient relationship (DPR) is considered to be the core element in the ethical principles of medicine. DPR is usually developed when a physician tends to a patient s medical needs via check-up, diagnosis, and treatment in an agreeable manner. Due to the relationship, the doctor owes a responsibility to the patient to proceed toward the ailment or conclude the relationship successfully. In particular, it is essential that primary care physicians develop a satisfactory DPR in order to deliver prime health care to patients.
The physician-patient relationship is a foundation of clinical care. Physician-patient relationships can have profound positive and negative implications on clinical care. Ultimately, the overarching goal of the physician-patient relationship is to improve patient health outcomes and their medical care. Stronger physician-patient relationships are correlated with improved patient outcomes. As the relationship between physicians and patients becomes more important, it is essential to understand the factors that influence this relationship.
Frameworks for Physician-Patient Relationships Throughout history there has been much debate regarding the "ideal" physician-patient relationship. In 1992, Ezekiel and Linda Emanuel proposed four models for the physician-patient relationship: the paternalistic model, the interpretive model, the deliberative model, and the informative model. These models differ based on their understanding of four key principles: the goals of physician-patient interactions, the physician s obligations, the role of patient values, and the concept of patient autonomy.
Factors that Influence the Physician-Patient Relationship Although there are several factors that influence physician-patient relationships, the dynamic shared and sense of trust between physicians and patients are two critical components to their overall relationship.
Dynamic Between Physicians and Patients The dynamic between physicians and patients refers to the communication patterns and the extent to which decision making is shared between both parties. Effective physician-patient communication is an integral part of clinical practice and serves as the keystone of physician-patient relationships. Studies have shown the approach taken by physicians to communicate information is equally important as the actual information that is being communicated. This type of communication incorporates both verbal and nonverbal interactionsbetween physicians and patients.iEffective communication has been shown to influence a wide array of outcomesincluding: emotional health, symptoms resolution, function, pain control, and physiologic measures such as blood pressure levels. When miscommunication occurs, it can have severe negative implications in clinical caresuch as impeding patient understanding, expectations of treatment, treatment planning, decreasing patient satisfaction of medical care, and reducing levels of patient hopefulness.
In addition to having effective communication, it is important that medical decisions stem from a collaborative process between physicians and patients. Decision makingis a process in which patients should be involved from the very beginning, and the result is a decision which reflects the physician s medical knowledge as well as the patient s values and beliefs.ivCollaborative communication and decision making have been correlated with greater patient satisfaction and loyalty. Working from a collaborative framework along with effective physician-patient communication can also strengthen a physician s ability to utilize a personalized health care model through patient empowerment.v Trust Between Physician and Patients ".... patients must be able to trust doctors with their lives and health, and that maintaining trust is one core guidance for physicians..."
Birkhäuer et al, 2017 Trust is a fundamental characteristic of the physician-patient relationship. Patients must trust that their physicians will work in their best interests to achieve optimal health outcomes. Patients trust in their physicians has been demonstrated to be more important than treatment satisfactionin predictions of patient adherence to recommendations and their overall satisfaction with care.iStudies have also shown that trust is additionally a strong predictor of a patient continuing with their provider.iiTrust extends to many different aspects of the physician-relationships including, but not limited to: physicians willingness to listen to patients, patients believing that physicians value patient autonomy and ability to make informed decisions, and patients feeling comfortable enough to express and engage in dialogue related to their health concerns.
Physician-Patient Relationships Influence on the Future of Healthcare The idea of viewing physician-patient relationships as a core element of quality health care is not something new, however understanding and assessing the factors that influence this relationship is just beginning. Effective physician-patient communication has been shown to positively influence health outcomes by increasing patient satisfaction, leading to greater patient understanding of health problems and treatments available, contributing to better adherence to treatment plans, and providing support and reassurance to patients. Collaborative decision making enables physicians and patients to work as partners in order to achieve a mutual health goal. Trust within all areas of the physician-patient relationship is a critical factor that influences communication between both parties. As health care transforms into a more personalized and patient-centered model, the physician-patient relationship will significantly shape health outcomes. The personalized health care model encourages collaboration among physicians and patients in order to create shared health goals and the cultivation of a health plan to address identified problems. By understanding the factors that influence patient-physician relationships, in the future, health care providers will be able to address some of the barriers that prevent the adoption of more personalized approaches to health care.
The primary responsibility of a doctor is to ensure they can provide their patients with the best level of care. A talented doctor can perform these tasks efficiently while practising a range of soft skills, such as effective communication. When considering a career in medicine, it may be helpful to know the basic duties a doctor performs daily.
What are a doctor s responsibilities?
There are seven key tasks that make up a doctor s responsibilities that most perform as part of their daily working routine. The duties of a doctor may vary depending on where they work, the type of doctor they are and the conditions of the patients they treat that day. While there may be some differences in a doctor s primary tasks, outlined below are seven common duties that doctors within any speciality can typically perform. These include the following:
Diagnosing any illness and other conditions A Dr is qualified to diagnose a range of illness, injuries, diseases or pains that a patient may be experiencing. The made in several tests on a patient before they reach their final diagnosis to ensure their decision is accurate. They also want to ensure that they can rule other illnesses out the time it takes for a Dr to make a diagnosis depends on what the ailment is and the severity of symptoms that the patient showing. For injuries, doctors can usually make an accurate diagnosis straightaway, whereas diseases or chronic illness may take a few weeks to Dr to detect.
Planning and conducting a patient s course of treatment following a diagnosis, a doctor may then plan and prepare a course of treatment for the patient. Individuals in this profession use their technical knowledge and medical research skills to find the quickest and most effective form of treatment. This process may include finding suitable medication, providing care for any external wounds or referring the patient to be more specialised doctor.
A doctor typically discusses their recommended treatment course with the patient to ensure that the individual is happy to proceed. If the doctor is treating a child, they may require the parents permission to conduct the treatment plan.
Any stream follow-up care for patients if necessary if a doctor feels they cannot treat a patient effectively, they may refer the patient to a specialist organisation or healthcare provider. This may occur if a patient is experiencing problems with their teeth, eyes or mental health because a dentist, optometrist or psychiatrist is more likely to find the root of the issue.
The doctor may also ask the patient to make a follow-up appointment with them for a variety of reasons. The reasons may be to check the progress of symptoms, run further tests and administer higher or lower doses of medication. They may also ask patients to arrange a further appointment to discuss any blood test or laboratory results. For the Bulls, the doctor may want to redress bandages and thoroughly cleanse the cut to prevent infection.
Consulting with other healthcare professionals during their working day, a doctor may consult with other healthcare professionals that work at their organisation or a specialist unit. A doctor may ask a nurse practitioner to assist them with running tests or consult with a fellow doctor to gain a second expert opinion on the patient s case. If they wish to have a patient admitted to hospital they may communicate with hospital staff via telephone to arrange an appointment on behalf of the patient.
If a patient is experiencing symptoms that are associated with a specific area in medicine, a doctor may contact a specialist unit to consult with a specialist Dr. For example if a patient is complaining of frequent chest pains, a doctor may consult with cardiologist to discuss a suitable treatment plan.
Prescribing medication a doctor is also responsible for prescribing the most effective medicine for a patient s symptoms. They may write a prescription for the patient to take with them to a pharmacy or contact the pharmacy directly. Doctors can prescribe medication to either cure illness or offer relief from symptoms. This medication can take various forms, including tablets, gels, creams and liquids.
To ensure the prescribed medication is effective, the doctor may ask the patient to schedule a follow-up appointment. If the medicine has made no improvements to the patient s illness, the doctor can then consider other medications or alternative forms of treatment. It is crucial that a doctor is aware of the patient s allergies or intolerances before prescribing medication.
Staying updated with medical research a skilled doctor requires a wealth of technical knowledge to identify and treat ailments. As technological and medicinal research progresses, it is responsible to offer doctor to show that they are up to date on the latest advancements in the healthcare industry. This includes researching new diseases, understanding the risks and benefits of new medications and learning how to conduct new procedures.
So it was the duty of the concerned Dr act properly, according to medical protocol so that the condition of the patient should have not been deteriorated. The doctor takes an Hippocratic oath before entering into this noble profession.
Now let us see the oath taken be a doctor before entering the nobel profession of the Medical World. The tradition in medical school includes taking the Hippocratic Oath usually at graduation. The purpose of this review is to examine what that oath has been, what forms it currently has, and the implications for physicians in today s healthcare environment. The changes in health economics affect physicians as they try to follow the oath s allegiance to the individual patient s needs. At times, this goal conflicts with the perspective of the financial world s controls of insurance companies and medical groups and institutions. This difference of the physicians ethical perspectives from the business leaders regarding the philosophy of the value of the individual s health and life may be related to some aspect of physician burnout.
Many populations in the world know of the Hippocratic Oath for physicians as they begin the journey to care for patients. In this current era of medicine the frequency of students taking the oath has increased to nearly every one compared to the early twentieth century; however, few medical students and physicians actually know that the translations of the ancient words have become less complete, as well as quite varied from the classical translations. With more and more medical students taking an oath, the content actually has been simultaneously thinned. Certainly, the part addressed to faith in the Greek deities, in whom the ancient physicians believed, does not exactly apply for different locations and religions. It does honor the history of medicine and the bond with principles of the selfless tradition of healing. Now the act of saying the oath with peers has been viewed as a process of getting the diploma from medical school rather than a devoted allegiance to the purpose of medical education, namely, the best care of each patient by a competent physician. A true physician focuses his or her care of each patient not only on the use of skilful and current techniques but also on the recognition of the unique needs and welfare of the patient. This professional devotion of the compassionate physician to the patient may be eroded as the concept of the oath faces challenges from the increasing demands and restrictions by corporate entities. The years of education and training lead to the agreement with a code of ethics in medicine that emphasizes behavior to earn the trust of patients. Some of the burnout of physicians may indicate the loss of autonomy and the need to free physicians to return to the core content of the oath, i.e., to uphold the highest standards of care for the safety and health of each patient.
As per guidelines of MCI, Every member should get it framed in his or her office it should never be violated in its letter and spirit.
"I solemnly pledge myself to consecrate my life to service of humanity.
• Even under threat, I will not use my medical knowledge contrary to the laws of Humanity.
• I will maintain the utmost respect for human life from the time of conception.
• I will not permit considerations of religion, nationality, race, party politics or social standing to intervene between my duty and my patient.
• I will practice my profession with conscience and dignity.
• The health of my patient will be my first consideration.
• I will respect the secrets which are confined in me.
• I will give to my teachers the respect and gratitude which is their due.
• I will maintain by all means in my power, the honour and noble traditions of medical profession.
• I will treat my colleagues with all respect and dignity.
• I shall abide by the code of medical ethics as enunciated in the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002.
I make these promises solemnly, freely and upon my honour."
Whether this oath has been complied with properly by the doctor. We know that the human body is a very complex body. The doctor spent years to study the course of MBBS/MD/MS and any other specialized fields. Despite of all the facts they should be cautious during treatment of a patient because it is the patient who paid them for their livelihood. It is the utmost and noble duty of a doctor to adhere with the oath taken by him.
So it is very important to maintain trust between the patient and the concerned Doctor. The doctors should also adhere to their oath taken by them when entering into this noble profession.
If you have taken an oath, you have to stick on your oath but we do not find any such adherence in this case from the very beginning.
In this case the opposite party had stated many times that the complainant had not placed on record the ultrasound report which led to the diagnosis for the procedure and this itself shows the conduct of the complainant in coming to this Hon ble commission with unclean hands. The opposite party has also stated that when the complainant visited opposite parties no 1 and 2 and he was prescribed ultrasound and on the basis of the ultrasound report she was advised the procedure but no details have been provided regarding the ultrasound. It is really strange on the part of the opposite party that when the procedure was totally based on ultrasound and if it has been seen by them why did they not keep it on the history sheet of the patient or in the BHT of the patient. It is negligence of the doctor and not the patient. If the doctor would have taken the report of ultrasound how the patient could deny to give it. Therefore blaming complainant for not providing the ultrasound report is a lame excuse on the part of the opposite parties.
The opposite party has stated that when the patient came on 10.07.2017 for follow-up checkup with complaint of pain in the abdomen he was immediately advised for MRCP and MRCP was done at Diwan diagnostics, Ghaziabad. In this test ERCP was advised for further evaluation, therefore the patient was immediately and timely advised for ERCP from Fortis Hospital. So first we should know what is MRCP and what is ERCP.
What is a magnetic resonance cholangiopancreatography (MRCP)?
A magnetic resonance cholangiopancreatography (MRCP) is an imaging test to examine your pancreatic and biliary (bile duct) systems. This test uses a dye, infused into your veins through an intravenous (IV) line. The dye (called a contrast agent) helps produce clearer images of your organs and the tubes that connect them. The results help your healthcare provider diagnose conditions and plan treatment.
What does an MRCP diagnose?
Your healthcare provider may recommend an MRCP if you have unexplained abdominal pain.
This specialized type of contrast MRI helps your provider diagnose:
• Bile duct cancer (cholangiocarcinoma).
• Bile duct stones or cysts.
• Blocked or narrowed bile duct (biliary stricture).
• Blocked, narrowed or dilated pancreatic ducts.
• Dilated bile ducts.
• Gallstones.
• Inflammation in the pancreas (pancreatitis) or gallbladder (cholecystitis).
• Pancreatic cancer.
• Pancreatic cysts and pseudocysts.
TEST DETAILS Who performs an MRCP?
A radiology technologist usually performs an MRCP. A radiologist (a physician who specializes in medical imaging) will also be present and read the test results. MRCP is an outpatient procedure that takes place at a medical clinic or hospital.
What types of MRI scanners are used for MRCP?
Different medical facilities use different MRI scanners. The types include:
• Closed-bore MRI: You lie on an examination table that slides into a large cylinder-shaped tube surrounded by a powerful circular magnet. Your head and abdomen are inside the scanner. Some closed-bore MRIs now have wider tunnel openings (wide-bore MRIs).
• Open-bore MRI: These MRI scanners use magnets that are above and beneath you, but the sides are open. They re often much easier for people with claustrophobia (or other health concerns that make tight spaces uncomfortable) to tolerate.
What happens before an MRCP?
You should follow your healthcare provider s instructions to prepare for an MRCP. You may need to:
• Fast (not eat or drink) before the test.
• Make sure a family member or friend can drive you home after the test if you re receiving sedation.
• Notify your provider of any implanted metal devices you may have, such as a joint replacement, pacemaker or cochlear implant.
• Remove anything that has metal, such as jewelry (including any body piercings), hearing aids and dentures.
• Stop taking medications like nonsteroidal anti-inflammatory drugs (NSAIDs), as well as vitamins and herbal supplements.
• Receive a sedative as a pill or through an IV to help you relax if you have claustrophobia. Your care team may also advise closing your eyes to put you more at ease.
• Tell your provider if you have hay fever (allergic rhinitis), asthma, food allergies or are prone to hives (urticaria). These conditions may slightly increase your risk of an allergic reaction to the contrast dye.
What happens during an MRCP?
During an MRCP, your care team:
1. Offers you earplugs or headphones to help dull the noise of the scanner and protect your hearing. You ll still be able to hear your care team.
2. Positions you face up on the exam table, using straps and bolsters if needed, to help you stay in the desired position.
3. Places coiling devices that send and receive radio waves around your body.
4. Administers the IV dye, which may cause you to feel a brief cooling sensation.
5. Pushes controls to slide the exam table into the closed-bore MRI tunnel (or you lie on the open-bore table).
6. Leaves the room. The technologist can still see you through a window and communicate with you through a two-way intercom.
7. Runs a sequence of MRI scans. Your body may feel slightly warm. You need to remain still and hold your breath while the scanner takes the images.
How long does an MRCP take?
It takes about 15 minutes to run the series of scans for an MRCP. You may also get a standard abdominal MRI, which can take an extra 30 minutes.
What happens after an MRCP?
You can go home after your vital signs look good and the sedative (if you received one) wears off. Side effects from the dye or procedure are rare. You should alert your care team if you feel nauseated, have a headache or feel like you re having an allergic reaction. Someone should drive you home after the test. You can resume your usual activities and diet.
What are the benefits of an MRCP?
This specialized contrast MRI produces clear, detailed images of organs and ducts without the use of X-ray radiation. MRCP uses an MRI scanner, which creates an extremely powerful magnetic field and uses radiofrequency waves and computer processing to create images. The radiofrequency waves for an MRI are similar to those used for FM radio broadcasts you can listen to in your car. That means there s no radiation exposure.
What are the risks of an MRCP?
An MRCP is a relatively safe procedure. Potential risks include:
• Allergic reaction: It s rare for someone to experience an allergic reaction like anaphylaxis to the IV contrast agent or dye during an MRCP. The dye uses an element called gadolinium instead of iodine since iodine is more likely to cause a reaction.
• Claustrophobia: Lying in an enclosed space like an MRI scanner can be difficult -- if not impossible -- if you have claustrophobia (fear of enclosed spaces). About 1 in 8 people have claustrophobia, making it one of the more common phobias. Healthcare providers who perform MRCP tests are very familiar with this phobia and can give you a sedative to help you relax during the test.
Who should not get an MRCP?
After an MRCP, your kidneys filter out the contrast dye. But studies suggest that small amounts of the metal may stay in your body for months or years. Most people don t have any side effects because of it, but people with kidney problems (kidney disease or kidney failure) may not be able to undergo MRCP. You also shouldn t get an MRCP if you re pregnant or plan on becoming pregnant within a year.
RESULTS AND FOLLOW-UP When should I get the test results?
Your radiologist will read the imaging scans and send the results to your referring healthcare provider. It may take up to a week or two for your provider to get the test results. They ll review the results with you. Depending on the findings, you may need surgery or a different treatment.
When should I call my healthcare provider?
You should contact your healthcare provider if you develop hives or other signs of an allergic reaction when you get home. You should also let them know if symptoms like abdominal pain worsen.
FREQUENTLY ASKED QUESTIONS What s the difference between an ERCP and an MRCP?
An endoscopic retrograde cholangiopancreatography (ERCP) and MRCP check for the same pancreatic and biliary issues. An ERCP is more invasive and requires anesthesia. Gastroenterologists, doctors who specialize in digestive diseases, perform ERCPs.
During the procedure, your provider:
1. Inserts an endoscope (flexible tube with a camera and light) into your mouth and through the esophagus (food pipe) to reach the small intestine.
2. Slides a catheter (thin, flexible tube) through the endoscope to reach the bile ducts and pancreatic ducts.
3. Injects a dye through the catheter.
4. Uses fluoroscopy (moving X-ray images) to view the ducts as the dye travels through them.
An ERCP may take place at the same time as an upper endoscopy procedure. Your provider can also perform treatments during an ERCP. For instance, they can break up and remove stones or place stents to open blocked ducts. They can also do a biopsy to collect tissue samples for analysis. These procedures aren t possible with an MRCP.
The uncertainty of not knowing what s happening with your body can make you uneasy. An MRCP can provide answers. This relatively low-risk contrast MRI test helps your healthcare provider detect problems like pancreatitis, pancreatic cancer and gallstones. Different types of MRI scanners are available, depending on your needs and preferences. Your provider will discuss next steps with you based on your test findings.
After this the patient was sent for ERCP.
Endoscopic retrograde cholangiopancreatography, or ERCP, is a procedure to diagnose and treat problems in the liver, gallbladder, bile ducts, and pancreas. It combines X-ray and the use of an endoscope--a long, flexible, lighted tube. Your healthcare provider guides the scope through your mouth and throat, then down the esophagus, stomach, and the first part of the small intestine (duodenum). Your healthcare provider can view the inside of these organs and check for problems. Next, he or she will pass a tube through the scope and inject a dye. This highlights the organs on X-ray.
Why might I need ERCP?
You may need ERCP to find the cause of unexplained abdominal pain or yellowing of the skin and eyes (jaundice). It may be used to get more information if you have pancreatitis or cancer of the liver, pancreas, or bile ducts.
Other things that may be found with ERCP include:
• Blockages or stones in the bile ducts • Fluid leakage from the bile or pancreatic ducts • Blockages or narrowing of the pancreatic ducts • Tumors • Infection in the bile ducts Your healthcare provider may have other reasons to recommend an ERCP.
What are the risks of ERCP?
You may want to ask your healthcare provider about the amount of radiation used during the test. Also ask about the risks as they apply to you.
Consider writing down all X-rays you get, including past scans and X-rays for other health reasons. Show this list to your provider. The risks of radiation exposure may be tied to the number of X-rays you have over time.
If you are pregnant or think you could be, tell your healthcare provider. Radiation exposure during pregnancy may lead to birth defects.
Tell your healthcare provider if you are allergic to or sensitive to medicines, contrast dyes, iodine, or latex.
Some possible complications may include:
• Inflammation of the pancreas (pancreatitis) or gallbladder (cholecystitis). Pancreatitis is one of the most common complications and should be discussed with your provider ahead of time. Keep in mind, though, that ERCP is often performed to help relieve the disease in certain types of pancreatitis.
• Infection • Bleeding • A tear in the lining of the upper section of the small intestine, esophagus, or stomach • Collection of bile outside the biliary system (biloma) You may not be able to have ERCP if:
• You ve had gastrointestinal (GI) surgery that has blocked the ducts of the biliary tree • You have pouches in your esophagus (esophageal diverticula) or other abnormal anatomy that makes the test difficult to perform. Sometimes the ERCP is modified to make it work in these situations.
• You have barium within the intestines from a recent barium procedure since it may interfere with an ERCP There may be other risks depend based on your condition. Be sure to discuss any concerns with your healthcare provider before the procedure.
How do I get ready for ERCP?
Recommendations for ERCP preparation include the following:
• Your healthcare provider will explain the procedure and you can ask questions.
• You may be asked to sign a consent form that gives your permission to do the test. Read the form carefully and ask questions if something is not clear.
• Tell your healthcare provider if you have ever had a reaction to any contrast dye, or if you are allergic to iodine.
• Tell your healthcare provider if you are sensitive to or are allergic to any medicines, latex, tape, or anesthesia.
• Do not to eat or drink liquids for 8 hours before the procedure. You may be given other instructions about a special diet for 1 to 2 days before the procedure.
• If you are pregnant or think you could be, tell your healthcare provider.
• Tell your healthcare provider of all medicines (prescribed and over-the-counter) and herbal supplements that you are taking.
• Tell your healthcare provider if you have a history of bleeding disorders or if you are taking any blood-thinning medicines (anticoagulants), aspirin, ibuprofen, naproxen, or other medicines that affect blood clotting. You may be told to stop these medicines before the procedure.
• If you have heart valve disease, your healthcare provider may give you antibiotics before the procedure.
• You will be awake during the procedure, but a sedative will be given before the procedure. Depending on the anesthesia used, you may be completely asleep and not feel anything. You will need someone to drive you home.
• Follow any other instructions your provider gives you to get ready.
What happens during ERCP?
An ERCP may be done on an outpatient basis or as part of your stay in a hospital. Procedures may vary based on your condition and your healthcare provider s practices.
Generally, an ERCP follows this process:
1. You will need to remove any clothing, jewelry, or other objects that may interfere with the procedure.
2. You will need to remove clothes and put on a hospital gown.
3. An intravenous (IV) line will be put in your arm or hand.
4. You may get oxygen through a tube in your nose during the procedure.
5. You will be positioned on your left side or, more often, on your belly, on the X-ray table.
6. Numbing medicine may be sprayed into the back of your throat. This helps prevent gagging as the endoscope is passed down your throat. You will not be able to swallow the saliva that collects in your mouth during the procedure. It will be suctioned from your mouth as needed.
7. A mouth guard will be put in your mouth to keep you from biting down on the endoscope and to protect your teeth.
8. Once your throat is numbed and you are relaxed from the sedative. Your provider will guide the endoscope down the esophagus into the stomach and through the duodenum until it reaches the ducts of the biliary tree.
9. A small tube will be passed through the endoscope to the biliary tree, and contrast dye will be injected into the ducts. Air may be injected before the contrast dye. This may cause you to feel fullness in your abdomen.
10. Various X-ray views will be taken. You may be asked to change positions during this time.
11. After X-rays of the biliary tree are taken, the small tube for dye injection will be repositioned to the pancreatic duct. Contrast dye will be injected into the pancreatic duct, and X-rays will be taken. Again, you may be asked to change positions while the X-rays are taken.
12. If needed, your provider will take samples of fluid or tissue. He or she may do other procedures, such as the removal of gallstones or other blockages, while the endoscope is in place.
13. After the X-rays and any other procedures are done, the endoscope will be withdrawn.
What happens after ERCP?
After the procedure, you will be taken to the recovery room. Once your blood pressure, pulse, and breathing are stable and you are alert, you will be taken to your hospital room or discharged home. If this procedure was done as an outpatient, plan to have someone drive you home.
You will not be allowed to eat or drink anything until your gag reflex has returned. You may have a sore throat and pain with swallowing for a few days. This is normal.
Many times, a rectal suppository of a certain medicine is given after the ERCP to decrease the risk of pancreatitis.
You may go back to your usual diet and activities after the procedure, unless your healthcare provider tells you otherwise.
Tell your healthcare provider if you have any of the following:
• Fever or chills • Redness, swelling, or bleeding or other drainage from the IV site • Abdominal pain, nausea, or vomiting • Black, tarry, or bloody stools • Trouble swallowing • Throat or chest pain that worsens Your healthcare provider may give you other instructions after the procedure, based on your situation.
Next steps Before you agree to the test or the procedure make sure you know:
• The name of the test or procedure • The reason you are having the test or procedure • What results to expect and what they mean • The risks and benefits of the test or procedure • What the possible side effects or complications are • When and where you are to have the test or procedure • Who will do the test or procedure and what that person s qualifications are • What would happen if you did not have the test or procedure • Any alternative tests or procedures to think about • When and how will you get the results • Who to call after the test or procedure if you have questions or problems • How much will you have to pay for the test or procedure So it is the duty of Dr to let you know and reason for this test, the risks and benefits of the test, possible effects of the complications or any alternative tests or procedures. No such written document has been filed showing that for this test the patient was told about all the pros and cons of the test. With ERCP in Fortis Hospital, Papillotomy also done at Fortis Hospital.. It means ERCP withPapillotomy.
ERCP AND PAPILLOTOMY BACKGROUND The role of early endoscopic retrograde cholangiopancreatography (ERCP) and papillotomy in the treatment of patients who have acute biliary pancreatitis without obstructive jaundice is uncertain.
METHODS We conducted a prospective, multicenter study in which 126 patients were randomly assigned to early ERCP (within 72 hours after the onset of symptoms) and endoscopic papillotomy for the removal of stones in the common bile duct, when appropriate, and 112 patients were assigned to conservative treatment. In the conservative-treatment group, ERCP was performed within three weeks if signs of biliary obstruction or sepsis developed. Overall mortality, mortality due to pancreatitis, and complications were compared in the two groups.
RESULTS Early ERCP was successful in 121 of the 126 patients in the invasive-treatment group. Endoscopic papillotomy was performed to remove bile-duct stones in 58 patients; stones were successfully extracted in 57. ERCP was performed in 22 of the 112 patients in the conservative-treatment group; papillotomy for stone removal was successful in 13 patients. Fourteen patients in the invasive-treatment group and 7 in the conservative-treatment group died within three months (P = 0.10); 10 patients in the invasive-treatment group and 4 in the conservative-treatment group died from acute biliary pancreatitis (P = 0.16). The overall rate of complications was similar in the two groups, but patients in the invasive-treatment group had more severe complications. Respiratory failure was more frequent in the invasive-treatment group, and jaundice was more frequent in the conservative-treatment group.
CONCLUSIONS In patients with acute biliary pancreatitis but without obstructive jaundice, early ERCP and papillotomy were not beneficial.
Alcohol abuse and gallstones account for approximately 80 percent of cases of acute pancreatitis.1,2 The pathogenesis of acute biliary pancreatitis is not fully understood and may be multifactorial.3-8 It is uncertain whether gallstones merely initiate or also maintain biliary pancreatitis. Most gallstones that initiate an episode of acute pancreatitis pass spontaneously through the ampulla of Vater into the duodenum and can subsequently be recovered in the feces within a few days.9 There has been much interest in early surgical and endoscopic removal of gallstones retained in the common bile duct. Kelly and Wagner randomly assigned 165 patients with acute biliary pancreatitis to early surgery (within 48 hours after admission) or delayed surgery (more than 48 hours after admission).10 Early surgery was associated with a much higher mortality rate (47.8 percent, vs. 11.8 percent with delayed surgery) in patients with severe pancreatitis. In a nonrandomized, prospective study, Stone et al. found no difference in mortality between 36 patients who underwent early surgery and 29 who underwent delayed surgery.11 In 1980, Safrany et al. recommended endoscopic retrograde cholangiopancreatography (ERCP) combined with endoscopic papillotomy for the treatment of acute biliary pancreatitis.12 In a randomized trial at one center, reported by Neoptolemos et al., 121 patients with acute biliary pancreatitis were assigned to either ERCP (and papillotomy if bile-duct stones were found) or conventional treatment within 72 hours after admission to the hospital.13 Patients with mild pancreatitis had similar outcomes regardless of the treatment. Among the patients with severe pancreatitis, the complication rate, but not the mortality rate, was significantly lower for those who underwent early ERCP. In a study at a center in Hong Kong, reported by Fan et al., 195 patients with acute pancreatitis with various causes were randomly assigned to either ERCP and papillotomy or conservative treatment within 24 hours after admission.14 The rates of mortality and local and systemic complications were similar in the two groups; the incidence of biliary sepsis was significantly lower with early ERCP and papillotomy. The studies by Neoptolemos et al. and Fan et al. included patients with obstructive jaundice and bilirubin concentrations up to 37 mg per deciliter (630 μmol per liter).13,14 There is good evidence that early endoscopic intervention is the procedure of choice in patients with stone impaction and cholangitis.15 We performed a prospective, randomized, multicenter trial to compare early ERCP (within 72 hours after the onset of symptoms) with conservative treatment in patients with biliary pancreatitis but without signs of obstructive jaundice.
Methods STUDY DESIGN Table 1.
Criteria for the Inclusion of Patients in a Trial of Early ERCP and Papillotomy as Compared with Conservative Treatment.
Before study entry, patients had to meet all the inclusion criteria listed in Table 1. Patients who met the criteria for inclusion were randomly assigned to receive early treatment with ERCP (invasive-treatment group) or noninvasive treatment (conservative-treatment group). Hematologic and biochemical tests were performed, according to the protocol, at admission, on days 2, 3, 5, 7, 14, and 21, and at discharge. The pancreatitis was assumed to have a biliary origin if gallstones were seen on ultrasonographic or computed tomographic scans or if two of the following three laboratory abnormalities were present17,18: an elevated alkaline phosphatase level ( 125 U per liter), an elevated alanine aminotransferase level ( 75 U per liter), or an elevated bilirubin level ( 2.3 mg per deciliter [39 μmol per liter]).
After three months, all patients were reexamined; studies included red- and white-cell counts; measurements of pancreatic and liver enzymes, renal function, electrolytes, and serum lipids; and ultrasonography.
The severity of the pancreatitis was classified before treatment according to the modified Glasgow criteria.19 Patients were classified as having severe disease if three or more of the following criteria were met: an age over 55 years, a white-cell count higher than 15,000 per cubic millimeter, a blood glucose level higher than 200 mg per deciliter (11 mmol per liter), a serum urea nitrogen level higher than 45 mg per deciliter (16 mmol per liter), an albumin level lower than 32 g per liter, a calcium level lower than 8 mg per deciliter (2.0 mmol per liter), a lactate dehydrogenase level higher than 600 IU per liter, and a partial pressure of arterial oxygen lower than 60 mm Hg. Patients were classified as having mild disease if fewer than three of the criteria were met and were classified as having disease of undefined severity if two of the criteria were met but not all the values were available.
If stones were detected in the common bile duct at ERCP, papillotomy was performed to extract them. In the conservative-treatment group, ERCP was performed within three weeks after randomization if the patient had a temperature higher than 39°C, an increase in the serum bilirubin level of more than 3 mg per deciliter (50 μmol per liter) within five days, or persistent biliary cramps. Data from these patients were included in the analysis of the data in the conservative-treatment group.20 After three weeks, ERCP could be performed in any patient, if indicated.
The participating centers agreed on the following principles of conservative treatment: replacement of fluid, electrolyte, and colloid losses according to the levels of urinary excretion and according to the observed values for the hematocrit, serum albumin concentration, central venous pressure, and pulmonary-artery wedge pressure; intravenous alimentation with glucose and lipids if indicated in a patient with a prolonged course of disease; insulin therapy if blood glucose levels exceeded 200 mg per deciliter (11 mmol per liter); assisted ventilation if the partial pressure of oxygen could not be maintained at a level higher than 60 mm Hg with an oxygen mask; nasogastric suction only in the case of gastric paresis and ileus; and antibiotic therapy only if the temperature rose above 39°C. The study protocol was approved on June 20, 1989, by the ethics committee of the Georg August University in Göttingen, Germany, and the approval was accepted by the other centers. All patients gave written informed consent before randomization.
The outcome measure was mortality due to pancreatitis within three months after enrollment. The incidence of local and systemic complications was compared between groups.
STATISTICAL ANALYSIS Assuming mortality rates of 8 percent in the conservative-treatment group and 2 percent in the invasive-treatment group (as reported in previous clinical studies13,14), we estimated that 190 patients would be required per group when a two-sided test was applied to the data (α = 0.05, β = 0.2).21,22 The trial was stopped according to the protocol after the second planned interim unblinded analysis by an independent board of reviewers from the departments of medical statistics and internal medicine of the University of Göttingen. The participating investigators in the trial were not involved in this decision. At that time, 10 of 126 patients in the invasive-treatment group (7.9 percent) and 4 of 112 in the conservative-treatment group (3.6 percent) had died of pancreatitis. Therefore, it was highly unlikely that superiority of the invasive treatment would be shown, which was the primary goal of the study. Even if there were no additional deaths in the invasive-treatment group, the mortality rate if the size of that group reached 190 would be 5.3 percent, which is higher than the rate in the conservative-treatment group.
Differences in mortality and complication rates were analyzed by logistic regression.23 The treatment assignment, prognosis (based on whether the disease was classified as severe, mild, or of undefined severity), sex, and age were included in the model. In addition, we included three binary variables for center effects, because the P values for the patients treated at three centers reached the 10 percent level in a forward-selection procedure with the main outcome variable (odds ratio for death in the invasive-treatment group vs. the conservative-treatment group, in one center, 22.6; 95 percent confidence interval, 1.0 to 583.6; P = 0.05; odds ratio at the second center, 18.9; 95 percent confidence interval, 0.9 to 472.3; P = 0.06; odds ratio at the third center, 6.6; 95 percent confidence interval, 1.1 to 75.8; P = 0.02). The results are presented as adjusted odds ratios and 95 percent confidence intervals. The null hypothesis of no treatment effect was tested by the two-sided asymptotic test of Wald.22 P values are two-tailed, and values of less than 0.05 were considered to indicate statistical significance. All analyses were performed according to the intention-to-treat principle.20 Results From November 1989 to February 1994, 339 consecutive patients at 22 centers were suspected of having biliary pancreatitis. A total of 101 patients could not be randomly assigned to a treatment group because of symptoms requiring early ERCP (a temperature higher than 39°C or a bilirubin level higher than 5 mg per deciliter [90 μmol per liter], persistent biliary cramps, an onset of symptoms more than 72 hours before ERCP could be performed, refusal to participate, or an age under 18 years).
The remaining 238 patients were randomly assigned by means of a stratified block procedure to either early ERCP (126 patients) or conventional management (112). Thirty-two patients (19 in the invasive-treatment group and 13 in the conservative-treatment group) were found after randomization not to have met all the inclusion criteria: in 12 patients ERCP could not be performed within 72 hours after the commencement of symptoms, 12 had serum bilirubin concentrations higher than 5 mg per deciliter, 6 had nonbiliary causes of pancreatitis, 1 was younger than 18 years, and 1 had coagulation abnormalities. These patients remained in the study and their data were analyzed on an intention-to-treat basis.20 Table 2.
Characteristics of the 238 Patients Randomly Assigned to Invasive or Conservative Treatment.
Of the 238 randomized patients, 142 were women and 96 were men (Table 2). The percentage of women was higher in the conservative-treatment group than in the invasive-treatment group. The two groups were similar with regard to age, height, weight, severity of disease, and medical history (pancreatic, gallstone, or peptic ulcer disease and earlier gastric or gallbladder surgery). A mean of 10.8 patients (range, 6 to 29) were enrolled at each center. Three centers enrolled 20 or more patients.
RESULTS OF ERCP AND PAPILLOTOMY In the invasive-treatment group, early ERCP was successful in 121 of the 126 patients (96 percent). In 58 patients (46 percent), bile-duct stones were detected, and endoscopic papillotomy was performed. Stones were successfully extracted in 57 of these patients. In the conventional-treatment group, elective ERCP was performed during the three-week observation period in 22 patients (20 percent) because of increasing jaundice (in 8 patients), a temperature higher than 39°C (in 8), or biliary cramps (in 6). The common bile duct could be visualized in 19 of the 22 patients (86 percent); bile-duct stones were detected in 13 (59 percent). The stones were removed by means of papillotomy in all 13. The main reason for the failure of ERCP in both groups was edema or hemorrhagic inflammation of the duodenum and papillary or juxtapapillary diverticula.
Two patients in the invasive-treatment group had bleeding after the papillotomy. One patient, who needed four units of blood, died from biliary sepsis due to an incarcerated stone that could not be removed. Bleeding in the other patient was controlled by a local injection of epinephrine (at a dilution of 1:10,000) during a second endoscopy; blood transfusion was not needed. There were no other immediate complications, such as perforation of the duodenal wall, in either group.
MORTALITY AND COMPLICATIONS Table 3.
Risk of Death and Selected Complications in the Two Treatment Groups.
Twenty-one patients (9 percent) -- 14 in the invasive-treatment group and 7 in the conventional-treatment group -- died within three months after the onset of pancreatitis (P = 0.10) (Table 3). Ten patients in the invasive-treatment group and four in the conservative-treatment group died from the direct consequences of acute biliary pancreatitis (P = 0.16) (Table 3). Four patients in the invasive-treatment group and three in the conservative-treatment group died of causes unrelated to pancreatitis. All the patients who died were older than 55 years (range, 56 to 90 years in the invasive-treatment group and 62 to 93 years in the conservative-treatment group).
Table 4.
Complications in the Treatment Groups.
The overall rate of complications was similar in the two groups, but patients in the invasive-treatment group had more severe complications (Table 4). Complications occurred in 58 of the patients assigned to early ERCP (46 percent) and in 57 of those assigned to conservative treatment (51 percent). Respiratory failure was more frequent in the invasive-treatment group (P = 0.03), and jaundice was more frequent in the conservative-treatment group (P = 0.02) (Table 3). The findings were similar when the 32 patients who did not meet all the inclusion criteria were excluded from the analysis (data not shown).
Now this test establishes the fact that patient is suffering from pancreatitis with the moderate free fluid in peritoneal cavity. Now one more complication has been developed and that is pancreatitis with the moderate free fluid in peritoneal cavity.
PANCREAPEDIA Prevention of ERCP-induced Pancreatitis Abstract:
Pancreatitis is a common, costly, and occasionally devastating complication of endoscopic retrograde cholangiopancreatography (ERCP).Since post-ERCP pancreatitis (PEP) is important and potentially preventable, a comprehensive approach to risk reduction should be employed by all who perform ERCP. Strategies to reduce the incidence of PEP, which should be considered in every case, include thoughtful patient selection, risk-stratification, sound procedural technique, prophylactic pancreatic stent placement, and pharmacoprevention. Despite advances in all these areas, however, the incidence of PEP remains as high as 15% in high-risk cases. Thus additional research towards the goal of eliminating PEP is necessary. To this end, there are several ongoing and upcoming initiatives that will help elucidate the pathophysiology of PEP and optimize prophylactic interventions. Herein is an evidence-based review of approaches to prevent pancreatitis after ERCP, as well as an overview of pressing research questions in this important area.
1. Overview Despite important advances over the last several decades, post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) remains the most frequent complication of ERCP, occurring in 2-15% of cases, and accounting for substantial morbidity, occasional mortality, and increased healthcare expenditures (58, 80). Approximately 10% of those who develop PEP will follow a severe clinical course that results in prolonged hospitalization and/or additional interventions, leading to significant patient suffering (58, 80). It s been estimated that 700,000 ERCPs are performed annually in the United States. Assuming a mid-range post-ERCP pancreatitis rate of 5%, more than 35,000 cases of PEP occur in the US each year; average Medicare reimbursement for PEP is approximately $6000, resulting in an estimated annual cost burden in excess of $200 million (1). Furthermore, PEP is a source of significant endoscopist stress (78) and has been the most common reason for malpractice lawsuits relating to ERCP (33). Given the magnitude of this problem, prevention of PEP remains a major clinical and research priority.
2. Definition PEP is most frequently diagnosed according to consensus criteria originally established in 1991: 1) new or increased abdominal pain that is clinically consistent with a syndrome of acute pancreatitis; and 2) associated pancreatic enzyme elevation at least three times the upper limit of normal twenty-four hours after the procedure; and 3) resultant hospitalization (or prolongation of existing hospitalization) of at least two nights (36, 58). This definition is straightforward and widely accepted, but is primarily limited by its subjective nature. Specifically, the interpretation of post-ERCP pain and the decision to hospitalize a patient after the procedure - both central to the consensus diagnosis of PEP - are nonobjective and variable across practice styles and institutional policies. Indeed, practitioners with a lower threshold to hospitalize patients after ERCP may observe a higher rate of PEP, and vice versa. Thus, between-study and between-center comparisons of PEP rates must be interpreted with caution, and blinding to treatment allocation is particularly important in PEP prevention trials.
A proposed alternative to the consensus definition is the standard clinical definition of acute pancreatitis, which mandates presence of 2 of the 3 following features: 1) abdominal pain typical of acute pancreatitis; 2) at least a 3-fold elevation in serum amylase or lipase levels; and 3) evidence of pancreatitic inflammation on cross-sectional imaging (14). A prospective comparative study demonstrated that the clinical definition is more sensitive than the consensus definition, (9) however the clinical impact of this more sensitive diagnostic approach - which may only capture additional mild (self-limited) cases - is unclear. Further, the radiation exposure and costs of systematic CT scanning in all patients with post-ERCP pain are not justified.
Given the limitations of both definitions, additional research aiming to elucidate a practical and accurate diagnostic tool for PEP is of substantial importance. Ideally, this tool would be objective, applicable early in the course of disease, and would reliably diagnose patients destined to develop a clinically important adverse course, in whom hospitalization (and other interventions) is likely to be beneficial.
3. Pathophysiology Our understanding of the mechanisms underlying PEP has evolved slowly and remains limited. As the only true human model for the study of acute pancreatitis, fully elucidating the pathophysiology of PEP is of substantial importance, not only to guide the development of novel pharmacologic interventions, but also to expand our understanding of pancreatitis in general. It is hypothesized that PEP results from some combination of mechanical, thermal, chemical, allergic, or infectious injury, and/or increased pancreatic duct hydrostatic pressure. This initial injury leads to premature intra-pancreatic activation of trypsinogen (111), which - in patients with genetic or environmental predisposition - incites the inflammatory cascade. The relative contribution of each of the aforementioned injurious factors remains unclear and is probably variable, but no single factor appears dominant. Thus a multifactorial approach involving several complimentary pharmacologic and mechanical prophylactic measures addressing different mechanisms of injury may be the most effective approach to PEP prevention. Alternatively, interventions that impact downstream inflammatory targets (e.g. zymogen activation or the early inflammatory cascade) or patient predisposition (e.g. microbiome) may prove most effective. A principal objective of an upcoming large-scale comparative effectiveness trial of indomethacin and prophylactic stent placement is to develop a robust repository of biological specimens from study participants to drive translational research elucidating the pathophysiology of PEP and pancreatitis in general.
4. Framework for a Comprehensive Approach to PEP Prevention Since PEP is potentially preventable, a comprehensive approach to risk reduction should be employed by all who perform ERCP (Figure 1). Preventive strategies can be broadly divided into 5 areas: (1) appropriate patient selection, (2) risk stratification of patients undergoing ERCP and meaningful use of this information in clinical decision-making, (3) atraumatic and efficient procedural technique, (4) prophylactic pancreatic stent placement, and (5) pharmacoprevention.
Figure 1: Framework for a comprehensive approach to post-ERCP pancreatitis prevention All five strategy areas should be considered in every case, and the latter two implemented when appropriate.
5. Patient Selection Thoughtful patient selection prior to ERCP remains the most important strategy in reducing the incidence of PEP. Endoscopic ultrasound (EUS) and magnetic resonance cholangiopancreatography (MRCP) allow highly accurate pancreaticobiliary imaging while avoiding the significant risks of ERCP (68, 108, 112). Two large meta-analyses have demonstrated that EUS is highly sensitive and specific in the detection of bile duct stones (sensitivity 89-94%; specificity 94-95%) (62, 133).Similarly, MRCP has a sensitivity of 85 to 92% and a specificity of 93 to 97% for the same indication,(112, 136) although MRI appears less sensitive than EUS for stones smaller than 6 mm (19, 143). Additionally, EUS, MRI, and other non-invasive modalities such as radionucleotide-labeled scan and percutaneous drain fluid analysis are very accurate in diagnosing a multitude of other pancreaticobiliary processes (e.g. chronic pancreatitis, malignancy, and leaks), often obviating the need for ERCP (37, 61, 82).
Indeed, the utilization of ERCP as a diagnostic procedure has steadily declined in favor of less invasive but equally accurate alternative tests, and ERCP has appropriately become a near-exclusively therapeutic procedure reserved for patients with a high pre-test probability of intervention (93, 96). This trend is consistent with recent clinical practice guidelines on the role of endoscopy in the evaluation of choledocholithiasis and the National Institutes of Health consensus statement on ERCP for diagnosis and therapy, both favoring less invasive tests over ERCP in the diagnosis of biliary disease (2, 32).
An exception to the widespread practice of reserving ERCP for patients with a high likelihood of therapeutic intervention has been the evaluation of patients with suspected sphincter of oddi dysfunction (SOD), for which an accurate, less-invasive alternative to ERCP-guided sphincter of Oddi manometry (SOM) remains elusive (40, 113). Even when considering patients for SOM, however, thoughtful clinical judgment is necessary to select those who are most likely to benefit from the procedure. A recent multi-center randomized trial (the EPISOD study) has demonstrated that there appears to be no role for ERCP in patients with suspected SOD but no laboratory or radiographic abnormalities (previously known as type 3 SOD) (34). Additional studies are necessary to determine whether diagnostic ERCP with SOM is truly beneficial in cases of suspected type 2 biliary or pancreatic SOD (recurrent unexplained pancreatitis). Pending such studies, many experts believe ERCP remains reasonable in such cases after careful assessment of the risk-benefit ratio and detailed informed consent. Another possible exception to the therapeutic ERCP trend may be the evaluation of biliary complications in liver transplant recipients, for whom a recent retrospective study suggested that diagnostic ERCP is a reasonable and efficient clinical approach in this patient population based on a high likelihood of therapeutic intervention and a very low rate of complications, in particular PEP (48).
6. Recognizing Patients at Increased Risk for PEP A substantial amount of research over the last two decades has contributed to our understanding of the independent risk factors for post-ERCP pancreatitis. These risk factors can be divided into patient-related and procedure-related characteristics. The definite and probable patient-related risk factors that predispose to PEP are: a clinical suspicion of sphincter of SOD (regardless of whether or not sphincter of Oddi manometry is performed) (35, 53, 56, 58, 87, 89, 121), a history of prior PEP (27, 56, 59, 135), a history of recurrent pancreatitis (89), normal bilirubin (56, 94), younger age,(27, 85, 90, 140) and female gender (56, 89, 140). The definite and probable procedure-related risk factors for PEP are: difficult cannulation (56, 58, 135), pancreatic sphincterotomy (27, 56), ampullectomy (46, 107), repeated or aggressive pancreatography (56, 58, 85, 89), and short-duration balloon dilation of an intact biliary sphincter (20-22) (15, 44, 139). Two recent systematic reviews have affirmed that most of these factors are independently associated with PEP (26, 43). Additional risk factors that have been implicated, but are not concretely accepted as independent predictors of PEP are precut (access) sphincterotomy (see below) (58, 89, 135), pancreatic duct wire passage (see below), biliary sphincterotomy, self-expanding metal stent placement, non-dilated bile duct, intraductal papillary mucinous neoplasm, and Billroth 2 anatomy.
Operator (endoscopist)-dependent characteristics have also been implicated in the risk of PEP. Endoscopist procedure volume is suggested to be a risk factor for PEP, although multi-center studies have not confirmed this trend, presumably because low-volume endoscopists tend to perform lower-risk cases (56, 58, 85, 109). Nevertheless, potentially dangerous cases (based on either patient-related factors or anticipated high-risk interventions) are best referred to expert medical centers where a high-volume endoscopist with expertise in prophylactic pancreatic stent placement can perform the case, and where more experience with rescue from serious complications may improve clinical outcomes (64, 65). Similarly, trainee involvement in ERCP is a possible independent risk factor for PEP, although results of existing multivariable analyses are conflicting (27, 56). It stands to reason that inexperienced trainees may augment procedure-related risk factors, such as prolonging a difficult cannulation or delivering excess electrosurgical current during an inefficient pancreatic sphicterotomy, etc. Therefore, an improved understanding of the process of ERCP training is necessary to minimize the contribution of trainee involvement to the development of PEP. Future research focused on defining ERCP training metrics and developing an evidence-based list of appropriate fellow cases based on stage of training and skill level is needed. Further, defining the optimal parameters that guide trainee-attending scope exchange during any particular case or intervention is necessary in order to maximize learning potential while minimizing patient risk.
Several additional points regarding clinical risk stratification are worth considering. First, predictors of PEP appear synergistic in nature (56). For example, a widely referenced multi-center study by Freeman et al., predating prophylactic pancreatic stent placement, showed that a young woman with a clinical suspicion of SOD, normal bilirubin, and a difficult cannulation has a risk of PEP in excess of 40% (56). Second, patients with a clinical suspicion of SOD, particularly women, are not only at increased risk for PEP in general, but appear more likely to develop severe pancreatitis and death (56, 58, 132). When considering the risk-benefit ratio of ERCP in this patient population, not only should the patient s overall risk of PEP be assessed, but their probability of experiencing a more dramatic clinical course should also be considered and discussed. Additionally, several clinical characteristics are thought to significantly reduce the risk of PEP. First, biliary interventions in patients with a pre-existing biliary sphincterotomy probably confer a very low risk of PEP. Prior sphincterotomy will have generally separated the biliary and pancreatic orifices, allowing avoidance of the pancreas, and making pancreatic sphincter or duct trauma unlikely. Further, patients with chronic pancreatitis, in particular those with calcific pancreatitis, are at low risk for PEP because of gland atrophy, fibrosis, and consequent decrease in exocrine enzymatic activity (56). Similarly, the progressive decline in pancreatic exocrine function associated with aging may protect older patients from pancreatic injury (83). Lastly, perhaps due to post-obstructive parenchymal atrophy, patients with pancreatic head malignancy appear to be relatively protected as well (12).
While understanding these aforementioned risk factors and incorporating them into clinical decision-making are important aspects of preventing PEP, additional research focused on developing more robust risk-stratification tools based upon existing literature and future multi-center studies is important. Such risk stratification instruments are unlikely to be developed using conventional statistical models (ie; multivariable regression analysis), and may require the use of novel, more advanced prediction methods involving artificial intelligence, such as machine learning - a technique that has already been successfully utilized in both business and medicine (137). In addition, a more specific understanding of how these tools output should concretely direct clinical management is necessary.
7. Meaningful Use of Risk-Stratification Information Armed with risk assessment information, clinicians can better inform patients about adverse events and tailor costly and potentially dangerous risk-reducing strategies. For example, prophylactic pancreatic stent placement and consideration of post-procedure hospital observation are appropriate for a patient predicted to be at high risk for PEP, but are not justified in low-risk cases.
Patient-related characteristics are not modifiable, but can be used (at least in part) to predict the risk of PEP prior to ERCP, allowing appropriate case selection and a meaningful discussion with the patient regarding the risk-benefit ratio of the procedure. For example, a young woman with suspected biliary SOD but moderate symptoms that are partially responsive to pain modulating therapy may elect to forgo ERCP after understanding her elevated risk of severe PEP. Procedural risk factors may occasionally be modified during the case (see below), but in combination with patient-related factors, allow a global assessment of a patient s overall risk profile, guiding clinical management. Indeed, the ability to risk-stratify patients can concretely influence the decision-making process that surrounds 1) proceeding with ERCP, 2) referral to a tertiary center, 3) fluid resuscitation, 4) prophylactic stent placement, 5) pharmacoprevention, and 6) post-procedural hospital observation.
8. Procedure Technique Efficient and atraumatic technical practices during ERCP are central to minimizing the risk of pancreatitis. Many of the procedure-related risk factors listed above, while predisposing to PEP, are mandatory elements of a successful case. Even though these high-risk interventions are unavoidable for execution of the clinical objective, certain strategies can be utilized to minimize procedure-related risk.
As mentioned, difficult cannulation and pancreatic duct injection are both independent risk factors for PEP. As such, interventions that improve the efficiency of cannulation and limit injection of contrast into the pancreas are likely to decrease the risk of pancreatitis. Guidewire-assisted cannulation accomplishes both, representing a major paradigm shift in ERCP practice. In contrast to conventional contrast-assisted cannulation, which may lead to inadvertent injection of the pancreatic duct or contribute to papillary edema, guidewire-assisted cannulation employs a small-diameter wire with a hydrophilic tip that is initially advanced into the duct, subsequently guiding passage of the catheter. Since the wire is thinner and more maneuverable than the cannula, it is easier to advance across a potentially narrow and off-angle orifice. Moreover, this process limits the likelihood of an inadvertent pancreatic or intramural papillary injection. A recent Cochrane Collaboration meta-analysis, which included 12 randomized controlled trials involving 3450 subjects, indeed confirms that guidewire-assisted cannulation reduces the risk of PEP by approximately 50% (RR 0.51, 95% CI 0.32 to 0.82) (134). A more recent prospective cohort study and randomized control trial revealed no difference in PEP between the contrast and guidewire-assisted groups (76, 88). However the results of these studies have been questioned for a multitude of reasons, including small sample sizes and selection bias.
When initial cannulation attempts are unsuccessful, alternative techniques to facilitate biliary access include pre-cut sphincterotomy, needle-knife fistulotomy, transpancreatic septomotomy, double-wire cannulation, and wire cannulation alongside a pancreatic stent (20, 131). While these techniques can be immensely helpful in gaining biliary access during challenging cases, some have been implicated as procedure-related risk factors for PEP. In many cases, however, the risk of PEP is actually driven by the preceding prolonged cannulation time that leads to increasing papillary trauma/edema. Therefore, implementing alternate cannulation techniques early in the case and in rapid succession is an important aspect of reducing PEP. This principle is best demonstrated by a meta-analysis of six randomized trials which showed that early precut sphincterotomy significantly reduced the risk of PEP when compared to repeated standard cannulation attempts (2.5% vs. 5.3%, OR 0.47) (23). Additional observational and randomized data have also suggested that precut sphincterotomy, especially if successful, is not an independent risk factor for PEP (66, 101, 129). Further studies are needed to help define the exact point at which the risk-benefit ratio favors precut sphincterotomy over repeated cannulation attempts, although the natural tendency to continue standard cannulation attempts beyond 5-10 minutes should be controlled, and alternative strategies should be attempted early in a difficult case.
The double wire technique is a common second-line approach when initial cannulation attempts result in repeated unintentional passage of the wire into the pancreas. The wire can be left in the pancreatic duct (PD), thereby straightening the common channel and partially occluding the pancreatic orifice, allowing subsequent biliary cannulation alongside the existing pancreatic wire. The double wire technique has been shown to improve cannulation success compared to standard methods, (72) although some data suggest a higher incidence of PEP when a wire is passed into the PD (70, 100, 138). Furthermore, a recent randomized controlled trials of difficult cannulation cases requiring double wire technique demonstrated that prophylactic pancreatic stent placement reduced the incidence of PEP in this patient population (73). On this basis, some experts believe that a prophylactic pancreatic stent should be placed in all patients requiring double wire cannulation, or when the wire inadvertently passes more than once into the pancreas. Others, including the author, however, believe that placement of a wire in the pancreas does not independently predispose to PEP, and that pancreatitis in this context is generally related to the preceding difficult cannulation. If the double wire technique is employed early in a low-risk patient (within 2-3 cannulation attempts), and the wire advances seamlessly into the PD in a typical pancreatic trajectory, pancreatic stent placement may not be necessary, particularly if rectal indomethacin is administered.
Other technical strategies that reduce the risk of PEP include limiting the frequency and vigor of pancreatic duct injection, performing SOM using the aspiration technique (120), and avoiding short-duration balloon dilation of an intact sphincter, especially without prophylactic pancreatic stent placement (84). In coagulopathic patients with choledocholithiasis and native papillae, balloon dilation can be avoided by providing real-time decompression with an endobiliary stent and repeating the ERCP with sphincterotomy and stone extraction when coagulation parameters have been restored. If this is not possible, and balloon dilation is mandatory, longer duration dilation (2-5 minutes) appears to result in lower rates of pancreatitis compared with 1-minute dilation (84). Of note, is that balloon dilation after biliary sphincterotomy to facilitate large stone extraction does not appear to increase the risk of PEP (69, 95).
9. Procedure Equipment Recent advances in ERCP equipment have increased technical success rates, but have unfortunately not reduced the risk of post-ERCP pancreatitis (57). In particular, the use of a sphincterotome has been shown to improve cannulation success compared with a standard cannula, but does not result in lower PEP rates (116). Similarly, comparative effectiveness studies evaluating sphincterotomes of various diameters have shown no difference in the risk of PEP (3, 60). There are no comparative effectiveness data evaluating the effect of various guidewires on the risk of pancreatitis (123).
Along these same lines, the type of contrast medium used during pancreatography does not appear to affect the incidence of PEP (63), and it remains unclear (but unlikely) that the now commonly used microprocessor controlled electrosurgical generators offer any protection over the previously popular pure-cut current for thermal injury-induced pancreatitis (54).
Overall, it appears that equipment has little to no impact on post-ERCP pancreatitis. Therefore practitioners should use the devices with which they are most comfortable for any particular indication in order to maximize technical success and efficiency, the latter of which is likely inversely related to the risk of PEP.
10. Prophylactic Pancreatic Stent Placement One of many proposed mechanisms of PEP implicates impaired pancreatic ductal drainage caused by trauma-induced edema of the papilla. Pancreatic stent placement (PSP) is therefore thought to reduce the risk of PEP by relieving pancreatic ductal hypertension that develops as a result of transient procedure-induced stenosis of the pancreatic orifice. Twelve published randomized controlled trials and as at least as many non-randomized trials have consistently demonstrated that PSP reduces the risk of PEP by approximately 60% (31, 92). Equally importantly, prophylactic pancreatic stents appear to profoundly reduce the likelihood of severe and necrotizing pancreatitis (31, 92).
It is important to keep in mind that the demonstrated benefits of PSP must be weighed against several potential disadvantages. First, attempting to place a PD stent with subsequent failure actually increases the risk of PEP above baseline by inducing injury to the pancreatic orifice, but providing no subsequent ductal decompression (30). Second, significant non-pancreatitis complications induced by PSP, such as stent migration and duct perforation, occur in ~4% of cases (92). Further, prolonged stent retention may induce ductal changes which resemble chronic pancreatitis (11), although the long term clinical relevance of these changes remains unclear. Finally, PSP is associated with some patient inconvenience and increased costs by mandating follow-up abdominal radiography to ensure spontaneous passage of the stent and additional upper endoscopy to retrieve retained stents in 5-10% of cases (24, 144).
Despite these considerations, PSP is widely regarded as an effective means of preventing PEP, is commonly used in academic medical centers in the United States (21), and is recommended by the European Society of Gastrointestinal Endoscopy (46). In light of the aforementioned concerns and the associated costs, however, PSP should be reserved for high-risk cases (38, 46). Based on the known independent patient and procedure-related risk factors for PEP, experts have suggested that the following cases are appropriate for prophylactic PD stent placement: 1) clinical suspicion of SOD (whether or not manometry or therapeutic intervention performed), 2) Prior PEP, 3) difficult cannulation, 4) precut (access) sphincterotomy, 5) pancreatic sphincterotomy (major or minor papilla), 6) endoscopic ampullectomy, 7) aggressive instrumentation or injection of the pancreatic duct, and 8) balloon dilation of an intact biliary sphincter (21, 55). Furthermore, preliminary studies have suggested that "salvage" PSP may be beneficial early in the course of PEP for patients who did not originally receive a stent, or in the case of early stent dislodgement (77, 86). Additional studies that include a control group are necessary to fully evaluate PSP for this indication.
Several questions surrounding PSP remain. First, the true magnitude of benefit of PSP remains unclear as none of the randomized controlled trials evaluating this intervention were blinded in nature. Studies without treatment allocation blinding are often biased in favor of the intervention and exaggerate perceived effects. Second, there is limited consensus regarding the optimal stent length and caliber (21). An early study suggested improved outcomes with 3 or 4-French stents (110), a subsequent trial showed no difference in PEP rates but a higher insertion success rate with the 5-Fr stents (24), and a recent network meta-analysis comprising the broader prophylaxis literature suggests that 5-Fr stent are most effective (4). Similarly, there is little consensus regarding optimal stent length. Most experts agree that the intra-pancreatic tip of the stent should not rest at the pancreatic genu or in a side-branch (55), however whether short stents (ending in the pancreatic head) or longer stents (ending in the body or tail) are preferable is unknown, and comparative effectiveness studies in this area are needed.
Finally, the acceptable amount of time that can be spent on the insertion process in cases of difficult pancreatic access is unknown. While the merits of PSP have been clearly presented above, if achieving pancreatic access proves difficult, there is presumably a point of diminishing returns when the risk of additional attempts outweighs the benefit of stent placement, especially if insertion eventually proves unsuccessful. Future clinical studies are unlikely to answer this question in a methodologically rigorous fashion, therefore endoscopists should be aware of this important clinical balance, and use their best judgment regarding the acceptable duration of time for stent insertion. One potential approach to circumvent this problem in cases of anticipated stent placement (for example ampullectomy or SOD cases) is to place and maintain a guidewire in the pancreatic duct early in the case in order to guarantee pancreatic duct access later on, avoiding the occasional phenomenon of failing to identify the pancreatic orifice due to the anatomic distortion that develops as a consequence of trauma, edema, or bleeding. Another approach is to place the prophylactic pancreatic stent prior to therapeutic intervention.
11. Pharmacoprevention Pharmacoprevention for PEP has been a major research priority in the last 3 decades. Since 1977, nearly 100 randomized controlled trials (RCT) have evaluated over 35 pharmacologic agents, with largely disappointing results. Unfortunately, clinical trials in this area have suffered from inadequate sample sizes, low methodological quality, and negative, conflicting, or inconclusive results. Moreover, the pessimism surrounding PEP pharmacoprevention had been amplified by prior positive meta-analyses of agents that were subsequently disproved by further clinical investigation (7, 8). Until recently, no medication for the prevention of PEP had been adopted into widespread clinical use.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) In the last decade, research focusing on rectal NSAIDs has provided renewed hope for pharmacoprevention. Four studies evaluating the protective effects of single-dose rectal indomethacin (97, 125) or diclofenac (79, 99) were reported between 2003-2008, and demonstrated conflicting, but generally encouraging results (79, 97, 99, 125). A meta-analysis of these RCTs, involving 912 patients, demonstrated a robust 64% reduction in PEP associated with rectal NSAIDs (relative risk [RR] 0.36, 95% CI 0.22 to 0.60) and no increase in associated adverse events (51).
Despite this meta-analysis, however, NSAIDs were seldom used in clinical practice due to the absence of conclusive RCT evidence (47). Moreover, it remained unclear whether NSAIDs provide incremental benefit over temporary pancreatic stent placement in high-risk cases. Therefore a large-scale, multi-center, methodologically rigorous RCT was conducted to definitively evaluate the efficacy of prophylactic rectal indomethacin for preventing PEP in high-risk cases (50). In this study, rectal indomethacin was associated with a 7.7% absolute risk reduction (number needed to treat = 13) and a 46% relative risk reduction in PEP (p=0.005). Additional RCTs of low-dose rectal diclofenac (105), the combination of rectal diclofenac plus infusion somatostatin (75), and the combination of indomethacin plus sublingual nitroglycerin (124) also demonstrated benefit. To date, eight RCTs of rectal NSAIDs have been published and recent meta-analyses (118, 128) have refined our estimates of effectiveness. On the basis of these data, 100 mg of rectal indomethacin or diclofenac can be recommended immediately before or after ERCP in all high-risk cases.
Controversy, however, remains within the advanced endoscopy community regarding the role of NSAIDs in low-risk cases. The aforementioned large-scale RCT - which represents the most definitive study of rectal NSAIDs to date - only enrolled subjects at elevated risk for pancreatitis, leading to the perception that these medications may only be effective in high-risk cases. A post hoc analysis of this RCT, however, demonstrated that the benefit associated with indomethacin was consistent across the entire spectrum of enrolled subjects risk for PEP. In other words, among study subjects, those at mildly elevated risk (e.g. difficult cannulation) derived similar benefit to those at more substantially elevated risk (e.g. suspicion of SOD and pancreatic sphincterotomy), suggesting that the indomethacin s relative risk reduction may be equivalent in all risk groups, including average risk cases (unpublished data). This observation is corroborated by data from the other published RCTs, which have demonstrated that rectal NSAIDs are effective in both high and average-risk cases (118, 128). In light of the very low cost of a single dose of NSAIDs, its highly favorable safety profile, and the above-mentioned data supporting its efficacy in low-risk cases, it is reasonable to consider these medications in all patients undergoing ERCP. The European Society of Gastrointestinal Endoscopy recommends rectal indomethacin or diclofenac for all patients undergoing ERCP as a grade A recommendation (45).
RCTs evaluating NSAIDs administered via non-rectal routes have demonstrated lack of efficacy in preventing PEP. Specifically, single RCTs of intravascular valdecoxib (18), oral diclofenac (28), and intramuscular diclofenac (117) have all yielded negative results. Even though these studies were underpowered and prone to type II statistical error, there are no existing data to support administration of prophylactic NSAIDs via any non-rectal route. Practitioners may be tempted to administer intravenous NSAIDs because of their widespread availability on anesthesia carts, their relative ease of delivery compared to suppository insertion, and the perception that their efficacy is a class effect. Endoscopists, however, should resist this temptation because of the above-mentioned data suggesting that IV NSAIDs are not effective, as well as the absence of proof of a class effect. Indeed, indomethacin and diclofenac are postulated to be specifically effective because they are particularly potent inhibitors of phospholipase A2 compared to other NSAIDs.
Available data indicate that rectal NSAIDs are effective in addition to PSP in high-risk cases, but to date, there are no clinical trial data examining whether indomethacin is effective when administered instead of PSP. Since PSP is technically challenging, potentially dangerous, time consuming, and costly (39, 52, 130, 144), major clinical and cost benefits in ERCP practice could be realized if rectal NSAIDs were to obviate the need for pancreatic stent placement. A post hoc, hypothesis-generating analysis of the aforementioned indomethacin RCT suggested that subjects who received indomethacin alone were less likely to develop PEP than those who received a pancreatic stent alone orthe combination of indomethacin and stent, even after adjusting for imbalances in PEP risk between groups (49). Additionally, a recent network meta-analysis comparing the data supporting PSP with those supporting prophylactic NSAIDs suggested that the combination of NSAIDs and PSP is not superior to rectal NSAIDs alone (5). Confirmatory research focusing on whether PSP remains necessary in the era of indomethacin prophylaxis is critical. To this end, a multi-center randomized non-inferiority trial comparing rectal indomethacin alone vs. the combination of indomethacin and prophylactic stent placement is in its final planning phase, should begin enrolling subjects late 2015, and will hopefully provide concrete guidance for this critical management issue. Until the results of this trial are available, however, the combination of rectal indomethacin and prophylactic stent placement should remain the standard approach to preventing PEP in high-risk patients.
Other Agents A recent systematic review of PEP pharmacoprevention aiming to provide an evidence-based research roadmap in this area identified bolus-administration somatostatin, sublingual nitroglycerin, and nafamostat as promising agents for which there is a high priority of additional confirmatory research. Topical epinephrine, aggressive intravenous administration of lactated ringer s solution, gabexate, ulinastatin, secretin, and antibiotics were identified as warranting exploratory research to justify a confirmatory RCT (81).
Somatostatin Somatostatin is a potent inhibitor of pancreatic exocrine function and may therefore prevent or mitigate the pathophysiologic processes that lead to pancreatic inflammation. Six of the 12 RCTs comparing somatostatin to placebo have yielded positive results. Benefit has been demonstrated more consistently with bolus administration (4 of 6 published studies positive) than with infusion (3 of 8 published studies positive). All four published meta-analyses have suggested benefit associated with somatostatin, especially when delivered as a bolus, with a number needed to treat of approximately 12 (6, 8, 104, 114). Additionally, an RCT of somatostatin in combination with diclofenac demonstrated benefit (75). Given these inconclusive but promising results, a high-quality confirmatory RCT of bolus somatostatin (the most practical and likely cost-effective approach) is necessary.
Nitroglycerin Nitroglycerin is a smooth muscle relaxant that may lower sphincter of Oddi (SO) pressure and increase pancreatic parenchymal blood flow.(126) Seven placebo-controlled RCTs have examined the effect of nitroglycerin on PEP. Three of these studies demonstrated a significant reduction in PEP (67, 98, 127), while the remaining four showed no benefit (16, 17, 74, 102). The two RCTs that used sublingual administration yielded positive results (67, 127). However, these results have been questioned because neither study defined pancreatitis according to the consensus definition (36), which may have contributed to the higher than expected event rates (18% (127) and 25% (67)). Transdermal administration of nitroglycerin has yielded conflicting results, with three RCTs showing no benefit (17, 74, 102), and one achieving a positive outcome (98). One RCT evaluating the role of intravenous nitroglycerin in preventing PEP in moderate to high-risk cases was terminated prematurely because of an interim analysis suggesting futility and a concerning frequency of adverse hemodynamic events (16). Five meta-analyses have demonstrated an approximately 30-40% reduction in risk associated with the use of nitroglycerin in the prevention of PEP (10, 13, 25, 42, 119). Since nitroglycerin is postulated to work by reducing SO pressure, it is unclear whether it would provide incremental benefit over pancreatic stent placement. Nevertheless, sublingual nitroglycerin may have a role in lower-risk cases, in resource-limited environments, or in place of pancreatic stent insertion. A recent small comparative effectiveness RCT demonstrated that the combination of sublingual nitroglycerin plus rectal indomethacin was more effective than indomethacin alone in a study sample that largely did not receive a pancreatic stent (124). Another methodologically rigorous large-scale multicenter RCT is warranted to confirm the effectiveness of combined sublingual nitroglycerin and rectal indomethacin in the appropriate patient population (high-risk cases in environments where stenting is not widely available). In the interim, sublingual nitroglycerin may be reasonable to consider in patients with a NSAIDs allergy or as an adjunct to rectal NSAIDs in high-risk cases that do not receive a prophylactic pancreatic stent.
Nafamostat mesylate Nafamostat mesylate is a low molecular weight protease inhibitor that inhibits trypsin, a proteolytic enzyme considered to play an initial role in the pathogenesis of pancreatitis. Nafamostat has a half-life 20-times longer and a potency 10 to 100-times greater than gabexate mesylate, another protease inhibitor that has been the focus of much prior research and has been utilized in clinical practice in parts of the world (45). Three RCTs have identified a significant reduction in PEP associated with nafamostat: Yoo et al. 2011, n = 266 (2.8% vs. 9.1% in the nafamostat group vs. control group, p = 0.03) (141), Choi et al. 2009, n = 704 (3.3% vs. 7.4% in the nafamostat vs. group control, p = .018),(29) and Park et al., n = 608 (three arms: 13.0% in control group vs. 4.0% in 20 mg nafamostat group vs. 5.1% in 50 mg nafamostat group, p 0.0001) (106). A recent meta-analysis demonstrated an approximately 60% benefit associated with nafamostat (RR = 0.41; 95%CI 0.28-0.59) (142). Major concerns related to the use of nafamostat are its high cost, need for a prolonged intravenous infusion (7-25 hours), and apparent absence of benefit in high-risk cases. In light of these potentially prohibitive disadvantages, statistical modeling analyses are necessary to determine whether a confirmatory RCT could show a magnitude of benefit large enough to justify use of nafamostat in clinical practice.
Epinephrine Epinephrine sprayed directly upon the papilla at the time of ERCP has been postulated to prevent PEP through direct relaxation of the SO and reduction of papillary edema by decreasing capillary permeability (103). Two RCTs have been conducted to evaluate the effect of topical epinephrine application on the papilla. In the study by Matsushita et al., patients were randomized to 10 ml of either 0.02% epinephrine or saline sprayed on the papilla after diagnostic ERCP (91). PEP occurred in 4 of the 185 subjects in the control group compared to none of the 185 subjects in the epinephrine group; however this difference did not meet statistical significance (p= 0.12). In a subsequent study by Hua et al., a total of 941 subjects undergoing diagnostic ERCP were randomized to 20 mL of 0.02% epinephrine or saline sprayed upon the papilla after ERCP (71). The incidence of pancreatitis was higher in the control group (31/480, 6.45%) than in the epinephrine group (9/461, 1.95%) (p= 0.009). Limitations of this study include the exclusion of all therapeutic ERCP and the atypical definition of PEP (elevated serum amylase levels associated with at least two clinical symptoms 6-24 hours after ERCP), reducing the external validity of the results in this era of high-quality diagnostic pancreaticobiliary imaging. Because it works primarily by SO relaxation, the impact of topical epinephrine in addition to pancreatic stent placement is unclear, but this agent may be effective as a surrogate stent, or in situations that do not warrant prophylactic stent placement. Even though topical epinephrine was categorized in research class 3, given the potential benefit, safety, low cost, and widespread availability of this agent, a large-scale confirmatory RCT in the appropriate patient population (high-risk therapeutic ERCP, limited availability of pancreatic stents) may be warranted (122).
Aggressive intravenous fluid (IVF) Mechanistically, aggressive intravenous fluid (IVF) hydration with lactated Ringer s solution (which attenuates the acidosis that appears to promote zymogen activation and pancreatic inflammation) may be an effective intervention for PEP by favorably affecting physiologic (pH) and micro-anatomic (pancreatic parenchymal perfusion) parameters. Recently, two observational studies (41, 115) and a pilot RCT (22) have suggested the potential benefit of IVF in reducing both the incidence and severity of PEP. This RCT had a very small sample size, defined PEP atypically (abdominal pain & pancreatic enzyme elevation 2 or 8 hours after ERCP; no hospitalization requirement), and administered IVF over 8-10 hours, a schedule that is likely unrealistic in the US.
Because IVF administration can be dangerous in older persons or in those with sodium retaining states and the volume of infusion at which the risk-benefit ratio of IVF is optimized remains unknown, additional research is necessary to establish an evidence-based approach. Since data supporting its use in non-ERCP pancreatitis are robust and many practitioners already administer IVF for PEP prevention, large-scale RCTs may be warranted despite the absence of robust preliminary PEP data.
12. Future Directions Despite the approaches outlined above, up to 15% of high-risk patients will still develop PEP. Appropriate patient selection, sound procedural technique, NSAIDs, and pancreatic stents have been effective in improving the problem, however additional research in multiple areas is necessary to achieve the goal of eliminating PEP. To this end there are at least 13 active registered pharmacoprevetion RCTs evaluating topical epinephrine, hemin, magnesium, antibiotics, NSAIDs, and aggressive IVF hydration, among others. In addition, there are ongoing comparative effectiveness trials assessing the optimal timing and dose of rectal NSAIDs. As mentioned, an RCT comparing rectal indomethacin alone vs. indomethacin + PSP is in it s final planning phase. These and future studies should aim to improve the quality of PEP prevention research, embracing adequate sample sizes, strict patient follow up, adherence to the intention-to-treat principle, blinding (especially in prophylactic stent trials), strict use of the consensus definition (until more accurate diagnostic criteria or tests are validated), and involvement of a data and safety monitoring board to ensure methodologic rigor and study data integrity.
13. References:
1. Healthcare Cost and Utilization Project 2012. (Accessed at http://hcupnet.ahrq.gov.)
2. NIH state-of-the-science statement on endoscopic retrograde cholangiopancreatography (ERCP) for diagnosis and therapy. Jan 14-16 2002.
3. Abraham NS, Williams SP, Thompson K, Love JR and MacIntosh DG. 5F sphincterotomes and 4F sphincterotomes are equivalent for the selective cannulation of the common bile duct. Gastrointest Endosc 63(4): 615-621, 2006. PMID: 16564862.
4. Afghani E, Akshintala VS, Khashab MA, Law JK, Hutfless SM, Kim KJ, et al. 5-Fr vs. 3-Fr pancreatic stents for the prevention of post-ERCP pancreatitis in high-risk patients: a systematic review and network meta-analysis. Endoscopy 46(7): 573-580, 2014. PMID: 24830399.
5. Akbar A, Abu Dayyeh BK, Baron TH, Wang Z, Altayar O and Murad MH. Rectal nonsteroidal anti-inflammatory drugs are superior to pancreatic duct stents in preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a network meta-analysis. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association 11(7): 778-783, 2013. PMID: 23376320.
6. Andriulli A, Leandro G, Federici T, Ippolito A, Forlano R, Iacobellis A, et al. Prophylactic administration of somatostatin or gabexate does not prevent pancreatitis after ERCP: an updated meta-analysis. Gastrointestinal Endoscopy 65(4): 624-632, 2007. PMID: 17383459.
7. Andriulli A, Leandro G, Federici T, Ippolito A, Forlano R, Iacobellis A, et al. Prophylactic administration of somatostatin or gabexate does not prevent pancreatitis after ERCP: an updated meta-analysis. Gastrointest Endosc 65(4): 624-632, 2007. PMID: 17383459.
8. Andriulli A, Leandro G, Niro G, Mangia A, Festa V, Gambassi G, et al. Pharmacologic treatment can prevent pancreatic injury after ERCP: a meta-analysis. Gastrointest Endosc 51(1): 1-7, 2000. PMID: 10625786.
9. Artifon EL, Chu A, Freeman M, Sakai P, Usmani A and Kumar A. A comparison of the consensus and clinical definitions of pancreatitis with a proposal to redefine post-endoscopic retrograde cholangiopancreatography pancreatitis. Pancreas 39(4): 530-535, 2010. PMID: 20093992.
10. Bai Y, Xu C, Yang X, Gao J, Zou DW and Li ZS. Glyceryl trinitrate for prevention of pancreatitis after endoscopic retrograde cholangiopancreatography: a meta-analysis of randomized, double-blind, placebo-controlled trials. Endoscopy 41(8): 690-695, 2009. PMID: 19670137.
11. Bakman YG, Safdar K and Freeman ML. Significant clinical implications of prophylactic pancreatic stent placement in previously normal pancreatic ducts. Endoscopy 41(12): 1095-1098, 2009. PMID: 19904701.
12. Banerjee N, Hilden K, Baron TH and Adler DG. Endoscopic biliary sphincterotomy is not required for transpapillary SEMS placement for biliary obstruction. Dig Dis Sci 56(2): 591-595, 2011. PMID: 20632105.
13. Bang UC, Nojgaard C, Andersen PK and Matzen P. Meta-analysis: Nitroglycerin for prevention of post-ERCP pancreatitis. Aliment Pharmacol Ther 29(10): 1078-1085, 2009. PMID: 19236312.
14. Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, et al. Classification of acute pancreatitis-2012: revision of the Atlanta classification and definitions by international consensus. Gut 62(1): 102-111, 2013. PMID: 23100216.
15. Baron TH and Harewood GC. Endoscopic balloon dilation of the biliary sphincter compared to endoscopic biliary sphincterotomy for removal of common bile duct stones during ERCP: a metaanalysis of randomized, controlled trials. Am J Gastroenterol 99(8): 1455-1460, 2004. PMID: 15307859.
16. Beauchant M, Ingrand P, Favriel JM, Dupuychaffray JP, Capony P, Moindrot H, et al. Intravenous nitroglycerin for prevention of pancreatitis after therapeutic endoscopic retrograde cholangiography: a randomized, double-blind, placebo-controlled multicenter trial. Endoscopy 40(8): 631-636, 2008. PMID: 18680075.
17. Bhatia V, Ahuja V, Acharya SK and Garg PK. Randomized Controlled Trial of Valdecoxib and Glyceryl Trinitrate for the Prevention of Post-ERCP Pancreatitis. Journal of clinical gastroenterology 45(2): 170-176, 2011. PMID: 20717044.
18. Bhatia V, Ahuja V, Acharya SK and Garg PK. A randomized controlled trial of valdecoxib and glyceryl trinitrate for the prevention of post-ERCP pancreatitis. Journal of clinical gastroenterology 45(2): 170-176, 2011. PMID: 20717044.
19. Boraschi P, Neri E, Braccini G, Gigoni R, Caramella D, Perri G, et al. Choledocolithiasis: diagnostic accuracy of MR cholangiopancreatography. Three-year experience. Magn Reson Imaging 17(9): 1245-1253, 1999. PMID: 10576709.
20. Bourke MJ, Costamagna G and Freeman ML. Biliary cannulation during endoscopic retrograde cholangiopancreatography: core technique and recent innovations. Endoscopy 41(7): 612-617, 2009. PMID: 19588290.
21. Brackbill S, Young S, Schoenfeld P and Elta G. A survey of physician practices on prophylactic pancreatic stents. Gastrointest Endosc 64(1): 45-52, 2006. PMID: 16813802.
22. Buxbaum J, Yan A, Yeh K, Lane C, Nguyen N and Laine L. Aggressive hydration with lactated ringer s solution reduces pancreatitis after endoscopic retrograde cholangiopancreatography. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association 12(2): 303-307 e301, 2014. PMID: 23920031.
23. Cennamo V, Fuccio L, Zagari RM, Eusebi LH, Ceroni L, Laterza L, et al. Can early precut implementation reduce endoscopic retrograde cholangiopancreatography-related complication risk? Meta-analysis of randomized controlled trials. Endoscopy 42(5): 381-388, 2010. PMID: 20306386.
24. Chahal P, Tarnasky PR, Petersen BT, Topazian MD, Levy MJ, Gostout CJ, et al. Short 5Fr vs long 3Fr pancreatic stents in patients at risk for post-endoscopic retrograde cholangiopancreatography pancreatitis. Clin Gastroenterol Hepatol 7(8): 834-839, 2009. PMID: 19447196.
25. Chen B, Fan T and Wang CH. A meta-analysis for the effect of prophylactic GTN on the incidence of post-ERCP pancreatitis and on the successful rate of cannulation of bile ducts. BMC Gastroenterol 10: 85, 2010. PMID: 20673365.
26. Chen JJ, Wang XM, Liu XQ, Li W, Dong M, Suo ZW, et al. Risk factors for post-ERCP pancreatitis: a systematic review of clinical trials with a large sample size in the past 10 years. Eur J Med Res 19: 26, 2014. PMID: 24886445.
27. Cheng CL, Sherman S, Watkins JL, Barnett J, Freeman M, Geenen J, et al. Risk factors for post-ERCP pancreatitis: a prospective multicenter study. Am J Gastroenterol 101(1): 139-147, 2006. PMID: 16405547.
28. Cheon YK, Cho KB, Watkins JL, McHenry L, Fogel EL, Sherman S, et al. Efficacy of diclofenac in the prevention of post-ERCP pancreatitis in predominantly high-risk patients: a randomized double-blind prospective trial. Gastrointestinal endoscopy 66(6): 1126-1132, 2007. PMID: 18061712.
29. Choi CW, Kang DH, Kim GH, Eum JS, Lee SM, Song GA, et al. Nafamostat mesylate in the prevention of post-ERCP pancreatitis and risk factors for post-ERCP pancreatitis. Gastrointest Endosc 69(4): e11-18, 2009. PMID: 19327467.
30. Choksi NS, Fogel EL, Cote GA, Romagnuolo J, Elta GH, Scheiman JM, et al. The risk of post-ERCP pancreatitis and the protective effect of rectal indomethacin in cases of attempted but unsuccessful prophylactic pancreatic stent placement. Gastrointest Endosc 81(1): 150-155, 2015. PMID: 25527053.
31. Choudhary A, Bechtold ML, Arif M, Szary NM, Puli SR, Othman MO, et al. Pancreatic stents for prophylaxis against post-ERCP pancreatitis: a meta-analysis and systematic review. Gastrointest Endosc 73(2): 275-282, 2011. PMID: 21295641.
32. Committee. ASoP. The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc 71: 1-9, 2010. PMID: 20105473.
33. Cotton PB. Analysis of 59 ERCP lawsuits; mainly about indications. Gastrointest Endosc 63(3): 378-382; quiz 464, 2006. PMID: 16500382.
34. Cotton PB, Durkalski V, Romagnuolo J, Pauls Q, Fogel E, Tarnasky P, et al. Effect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy: the EPISOD randomized clinical trial. JAMA 311(20): 2101-2109, 2014. PMID: 24867013.
35. Cotton PB, Garrow DA, Gallagher J and Romagnuolo J. Risk factors for complications after ERCP: a multivariate analysis of 11,497 procedures over 12 years. Gastrointest Endosc 70(1): 80-88, 2009. PMID: 19286178.
36. Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 37(3): 383-393, 1991. PMID: 2070995.
37. Darwin P, Goldberg E and Uradomo L. Jackson Pratt drain fluid-to-serum bilirubin concentration ratio for the diagnosis of bile leaks. Gastrointest Endosc 71(1): 99-104, 2010. PMID: 19945100.
38. Das A, Singh P, Sivak MV, Jr. and Chak A. Pancreatic-stent placement for prevention of post-ERCP pancreatitis: a cost-effectiveness analysis. Gastrointest Endosc 65(7): 960-968, 2007. PMID: 17331513.
39. Das A, Singh P, Sivak MV, Jr. and Chak A. Pancreatic-stent placement for prevention of post-ERCP pancreatitis: a cost-effectiveness analysis. Gastrointestinal endoscopy 65(7): 960-968, 2007. PMID: 17331513.
40. Di Francesco V, Brunori MP, Rigo L, Toouli J, Angelini G, Frulloni L, et al. Comparison of ultrasound-secretin test and sphincter of Oddi manometry in patients with recurrent acute pancreatitis. Dig Dis Sci 44(2): 336-340, 1999. PMID: 10063920.
41. DiMagno MJ, Wamsteker EJ, Maratt J, Rivera MA, Spaete JP, Ballard DD, et al. Do larger periprocedural fluid volumes reduce the severity of post-endoscopic retrograde cholangiopancreatography pancreatitis? Pancreas 43(4): 642-647, 2014. PMID: 24713841.
42. Ding J, Jin X, Pan Y, Liu S and Li Y. Glyceryl trinitrate for prevention of post-ERCP pancreatitis and improve the rate of cannulation: a meta-analysis of prospective, randomized, controlled trials. PloS one 8(10): e75645, 2013. PMID: 24098392.
43. Ding X, Zhang F and Wang Y. Risk factors for post-ERCP pancreatitis: A systematic review and meta-analysis. Surgeon, 2014. PMID: 25547802.
44. Disario JA, Freeman ML, Bjorkman DJ, Macmathuna P, Petersen BT, Jaffe PE, et al. Endoscopic balloon dilation compared with sphincterotomy for extraction of bile duct stones. Gastroenterology 127(5): 1291-1299, 2004. PMID: 15520997.
45. Dumonceau JM, Andriulli A, Deviere J, Mariani A, Rigaux J, Baron TH, et al. European Society of Gastrointestinal Endoscopy (ESGE) Guideline: prophylaxis of post-ERCP pancreatitis. Endoscopy 42(6): 503-515, 2010. PMID: 20506068.
46. Dumonceau JM, Andriulli A, Elmunzer BJ, Mariani A, Meister T, Deviere J, et al. Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - updated June 2014. Endoscopy 46(9): 799-815, 2014. PMID: 25148137.
47. Dumonceau JM, Rigaux J, Kahaleh M, Gomez CM, Vandermeeren A and Deviere J. Prophylaxis of post-ERCP pancreatitis: a practice survey. Gastrointest Endosc 71(6): 934-939, 939 e931-932, 2010. PMID: 20226455.
48. Elmunzer BJ, Debenedet AT, Volk ML, Sonnenday CJ, Waljee AK, Fontana RJ, et al. Clinical yield of diagnostic endoscopic retrograde cholangiopancreatography in orthotopic liver transplant recipients with suspected biliary complications. Liver Transpl 18(12): 1479-1484, 2012. PMID: 22888069.
49. Elmunzer BJ, Higgins PD, Saini SD, Scheiman JM, Parker RA, Chak A, et al. Does rectal indomethacin eliminate the need for prophylactic pancreatic stent placement in patients undergoing high-risk ERCP? Post hoc efficacy and cost-benefit analyses using prospective clinical trial data. The American journal of gastroenterology 108(3): 410-415, 2013. PMID: 23295278.
50. Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PDR, et al. A Randomized Trial of Rectal Indomethacin to Prevent Post-ERCP Pancreatitis. New England Journal of Medicine 366(15): 1414-1422, 2012. PMID: 22494121.
51. Elmunzer BJ, Waljee AK, Elta GH, Taylor JR, Fehmi SMA and Higgins PDR. A meta-analysis of rectal NSAIDs in the prevention of post-ERCP pancreatitis. Gut 57(9): 1262-1267, 2008. PMID: 18375470.
52. Fazel A, Quadri A, Catalano MF, Meyerson SM and Geenen JE. Does a pancreatic duct stent prevent post-ERCP pancreatitis? A prospective randomized study. Gastrointestinal endoscopy 57(3): 291-294, 2003. PMID: 12612504.
53. Fogel EL, Eversman D, Jamidar P, Sherman S and Lehman GA. Sphincter of Oddi dysfunction: pancreaticobiliary sphincterotomy with pancreatic stent placement has a lower rate of pancreatitis than biliary sphincterotomy alone. Endoscopy 34(4): 280-285, 2002. PMID: 11932782.
54. Freeman ML. Complications of endoscopic retrograde cholangiopancreatography: avoidance and management. Gastrointest Endosc Clin N Am 22(3): 567-586, 2012. PMID: 22748249.
55. Freeman ML. Pancreatic stents for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis. Clin Gastroenterol Hepatol 5(11): 1354-1365, 2007. PMID: 17981248.
56. Freeman ML, DiSario JA, Nelson DB, Fennerty MB, Lee JG, Bjorkman DJ, et al. Risk factors for post-ERCP pancreatitis: a prospective, multicenter study. Gastrointest Endosc 54(4): 425-434, 2001. PMID: 11577302.
57. Freeman ML and Guda NM. ERCP cannulation: a review of reported techniques. Gastrointest Endosc 61(1): 112-125, 2005. PMID: 15672074.
58. Freeman ML, Nelson DB, Sherman S, Haber GB, Herman ME, Dorsher PJ, et al. Complications of endoscopic biliary sphincterotomy. N Engl J Med 335(13): 909-918, 1996. PMID: 8782497.
59. Friedland S, Soetikno RM, Vandervoort J, Montes H, Tham T and Carr-Locke DL. Bedside scoring system to predict the risk of developing pancreatitis following ERCP. Endoscopy 34(6): 483-488, 2002. PMID: 12048633.
60. Garcia-Cano J and Gonzalez-Martin JA. Bile duct cannulation: success rates for various ERCP techniques and devices at a single institution. Acta Gastroenterol Belg 69(3): 261-267, 2006. PMID: 17168121.
61. Gardner TB and Levy MJ. EUS diagnosis of chronic pancreatitis. Gastrointest Endosc 71(7): 1280-1289, 2010. PMID: 20598255.
62. Garrow D, Miller S, Sinha D, Conway J, Hoffman BJ, Hawes RH, et al. Endoscopic ultrasound: a meta-analysis of test performance in suspected biliary obstruction. Clin Gastroenterol Hepatol 5(5): 616-623, 2007. PMID: 17478348.
63. George S, Kulkarni AA, Stevens G, Forsmark CE and Draganov P. Role of osmolality of contrast media in the development of post-ERCP pancreatitis: a metanalysis. Dig Dis Sci 49(3): 503-508, 2004. PMID: 15139506.
64. Ghaferi AA, Birkmeyer JD and Dimick JB. Hospital volume and failure to rescue with high-risk surgery. Med Care 49(12): 1076-1081, 2011. PMID: 22002649.
65. Ghaferi AA, Birkmeyer JD and Dimick JB. Variation in hospital mortality associated with inpatient surgery. N Engl J Med 361(14): 1368-1375, 2009. PMID: 19797283.
66. Gong B, Hao L, Bie L, Sun B and Wang M. Does precut technique improve selective bile duct cannulation or increase post-ERCP pancreatitis rate? A meta-analysis of randomized controlled trials. Surg Endosc 24(11): 2670-2680, 2010. PMID: 20414680.
67. Hao JY, Wu DF, Wang YZ, Gao YX, Lang HP and Zhou WZ. Prophylactic effect of glyceryl trinitrate on post-endoscopic retrograde cholangiopancreatography pancreatitis: a randomized placebo-controlled trial. World J Gastroenterol 15(3): 366-368, 2009. PMID: 19140238.
68. Hawes RH. The evolution of endoscopic ultrasound: improved imaging, higher accuracy for fine needle aspiration and the reality of endoscopic ultrasound-guided interventions. Curr Opin Gastroenterol 26(5): 436-444, 2010. PMID: 20703111.
69. Heo JH, Kang DH, Jung HJ, Kwon DS, An JK, Kim BS, et al. Endoscopic sphincterotomy plus large-balloon dilation versus endoscopic sphincterotomy for removal of bile-duct stones. Gastrointest Endosc 66(4): 720-726; quiz 768, 771, 2007. PMID: 17905013.
70. Herreros de Tejada A, Calleja JL, Diaz G, Pertejo V, Espinel J, Cacho G, et al. Double-guidewire technique for difficult bile duct cannulation: a multicenter randomized, controlled trial. Gastrointest Endosc 70(4): 700-709, 2009. PMID: 19560764.
71. Hua XL, Bo QJ, Gen GL, Wei QJ, Ming GZ, Fei L, et al. Prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis by epinephrine sprayed on the papilla. Journal of Gastroenterology and Hepatology 26(7): 1139-1144, 2011. PMID: 21392105.
72. Ito K, Fujita N, Noda Y, Kobayashi G, Obana T, Horaguchi J, et al. Pancreatic guidewire placement for achieving selective biliary cannulation during endoscopic retrograde cholangio-pancreatography. World J Gastroenterol 14(36): 5595-5600; discussion 5599, 2008. PMID: 18810780.
73. Ito K, Fujita N, Noda Y, Kobayashi G, Obana T, Horaguchi J, et al. Can pancreatic duct stenting prevent post-ERCP pancreatitis in patients who undergo pancreatic duct guidewire placement for achieving selective biliary cannulation? A prospective randomized controlled trial. J Gastroenterol 45(11): 1183-1191, 2010. PMID: 20607310.
74. Kaffes AJ, Bourke MJ, Ding S, Alrubaie A, Kwan V and Williams SJ. A prospective, randomized, placebo-controlled trial of transdermal glyceryl trinitrate in ERCP: effects on technical success and post-ERCP pancreatitis. Gastrointest Endosc 64(3): 351-357, 2006. PMID: 16923481.
75. Katsinelos P, Fasoulas K, Paroutoglou G, Chatzimavroudis G, Beltsis A, Terzoudis S, et al. Combination of diclofenac plus somatostatin in the prevention of post-ERCP pancreatitis: a randomized, double-blind, placebo-controlled trial. Endoscopy 44(1): 53-59, 2012. PMID: 22198776.
76. Kawakami H, Maguchi H, Mukai T, Hayashi T, Sasaki T, Isayama H, et al. A multicenter, prospective, randomized study of selective bile duct cannulation performed by multiple endoscopists: the BIDMEN study. Gastrointest Endosc 75(2): 362-372, 372 e361, 2012. PMID: 22248605.
77. Kerdsirichairat T, Attam R, Arain M, Bakman Y, Radosevich D and Freeman M. Urgent ERCP with pancreatic stent placement or replacement for salvage of post-ERCP pancreatitis. Endoscopy 46(12): 1085-1094, 2014. PMID: 25216326.
78. Keswani RN, Taft TH, Cote GA and Keefer L. Increased levels of stress and burnout are related to decreased physician experience and to interventional gastroenterology career choice: findings from a US survey of endoscopists. Am J Gastroenterol 106(10): 1734-1740, 2011. PMID: 21979198.
79. Khoshbaten M, Khorram H, Madad L, Ehsani Ardakani MJ, Farzin H and Zali MR. Role of diclofenac in reducing post-endoscopic retrograde cholangiopancreatography pancreatitis. J Gastroenterol Hepatol 23(7 Pt 2): e11-16, 2008. PMID: 17683501.
80. Kochar B, Akshintala VS, Afghani E, Elmunzer BJ, Kim KJ, Lennon AM, et al. Incidence, severity, and mortality of post-ERCP pancreatitis: a systematic review by using randomized, controlled trials. Gastrointest Endosc 81(1): 143-149 e149, 2015. PMID: 25088919.
81. Kubiliun NM, Adams MA, Akshintala VS, Conte ML, Cote GA, Cotton PB, et al. Evaluation of Pharmacologic Prevention of Pancreatitis Following Endoscopic Retrograde Cholangiopancreatography: a Systematic Review. Clin Gastroenterol Hepatol, 2015. PMID: 25579870.
82. Lambie H, Cook AM, Scarsbrook AF, Lodge JP, Robinson PJ and Chowdhury FU. Tc99m-hepatobiliary iminodiacetic acid (HIDA) scintigraphy in clinical practice. Clin Radiol 66(11): 1094-1105, 2011. PMID: 21861996.
83. Laugier R, Bernard JP, Berthezene P and Dupuy P. Changes in pancreatic exocrine secretion with age: pancreatic exocrine secretion does decrease in the elderly. Digestion 50(3-4): 202-211, 1991. PMID: 1812045.
84. Liao WC, Tu YK, Wu MS, Wang HP, Lin JT, Leung JW, et al. Balloon dilation with adequate duration is safer than sphincterotomy for extracting bile duct stones: a systematic review and meta-analyses. Clin Gastroenterol Hepatol 10(10): 1101-1109, 2012. PMID: 22642953.
85. Loperfido S, Angelini G, Benedetti G, Chilovi F, Costan F, De Berardinis F, et al. Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study. Gastrointest Endosc 48(1): 1-10, 1998. PMID: 9684657.
86. Madacsy L, Kurucsai G, Joo I, Godi S, Fejes R and Szekely A. Rescue ERCP and insertion of a small-caliber pancreatic stent to prevent the evolution of severe post-ERCP pancreatitis: a case-controlled series. Surg Endosc 23(8): 1887-1893, 2009. PMID: 19057957.
87. Maldonado ME, Brady PG, Mamel JJ and Robinson B. Incidence of pancreatitis in patients undergoing sphincter of Oddi manometry (SOM). Am J Gastroenterol 94(2): 387-390, 1999. PMID: 10022634.
88. Mariani A, Giussani A, Di Leo M, Testoni S and Testoni PA. Guidewire biliary cannulation does not reduce post-ERCP pancreatitis compared with the contrast injection technique in low-risk and high-risk patients. Gastrointest Endosc 75(2): 339-346, 2012. PMID: 22075192.
89. Masci E, Mariani A, Curioni S and Testoni PA. Risk factors for pancreatitis following endoscopic retrograde cholangiopancreatography: a meta-analysis. Endoscopy 35(10): 830-834, 2003. PMID: 14551860.
90. Masci E, Toti G, Mariani A, Curioni S, Lomazzi A, Dinelli M, et al. Complications of diagnostic and therapeutic ERCP: a prospective multicenter study. Am J Gastroenterol 96(2): 417-423, 2001. PMID: 11232684.
91. Matsushita M, Takakuwa H, Shimeno N, Uchida K, Nishio A and Okazaki K. Epinephrine sprayed on the papilla for prevention of post-ERCP pancreatitis. J Gastroenterol 44(1): 71-75, 2009. PMID: 19159075.
92. Mazaki T, Mado K, Masuda H and Shiono M. Prophylactic pancreatic stent placement and post-ERCP pancreatitis: an updated meta-analysis. J Gastroenterol 49(2): 343-355, 2014. PMID: 23612857.
93. Mazen Jamal M, Yoon EJ, Saadi A, Sy TY and Hashemzadeh M. Trends in the utilization of endoscopic retrograde cholangiopancreatography (ERCP) in the United States. Am J Gastroenterol 102(5): 966-975, 2007. PMID: 17319932.
94. Mehta SN, Pavone E, Barkun JS, Bouchard S and Barkun AN. Predictors of post-ERCP complications in patients with suspected choledocholithiasis. Endoscopy 30(5): 457-463, 1998. PMID: 9693893.
95. Misra SP and Dwivedi M. Large-diameter balloon dilation after endoscopic sphincterotomy for removal of difficult bile duct stones. Endoscopy 40(3): 209-213, 2008. PMID: 18264886.
96. Moffatt DC, Yu BN, Yie W and Bernstein CN. Trends in utilization of diagnostic and therapeutic ERCP and cholecystectomy over the past 25 years: a population-based study. Gastrointest Endosc 79(4): 615-622, 2014. PMID: 24119510.
97. Montano Loza A, Rodriguez Lomeli X, Garcia Correa JE, Davalos Cobian C, Cervantes Guevara G, Medrano Munoz F, et al. Effect of the rectal administration of indomethacin on amylase serum levels after endoscopic retrograde cholangiopancreatography, and its impact on the development of secondary pancreatitis episodes. Revista Espanola de Enfermedades Digestivas 99(6): 330-336, 2007. PMID: 17883296.
98. Moreto M, Zaballa M, Casado I, Merino O, Rueda M, Ramirez K, et al. Transdermal glyceryl trinitrate for prevention of post-ERCP pancreatitis: a randomized double-blind trial. Gastrointestinal Endoscopy 57(1): 1-7, 2003. PMID: 12518122.
99. Murray B, Carter R, Imrie C, Evans S and O Suilleabhain C. Diclofenac reduces the incidence of acute pancreatitis after endoscopic retrograde cholangiopancreatography. Gastroenterology 124(7): 1786-1791, 2003. PMID: 12806612.
100. Nakai Y, Isayama H, Sasahira N, Kogure H, Sasaki T, Yamamoto N, et al. Risk factors for post-ERCP pancreatitis in wire-guided cannulation for therapeutic biliary ERCP. Gastrointest Endosc 81(1): 119-126, 2015. PMID: 25442080.
101. Navaneethan U, Konjeti R, Lourdusamy V, Lourdusamy D, Mehta D, Sanaka MR, et al. Precut sphincterotomy: efficacy for ductal access and the risk of adverse events. Gastrointest Endosc, 2014. PMID: 25440676.
102. Nojgaard C, Hornum M, Elkjaer M, Hjalmarsson C, Heyries L, Hauge T, et al. Does glyceryl nitrate prevent post-ERCP pancreatitis? A prospective, randomized, double-blind, placebo-controlled multicenter trial. Gastrointest Endosc 69(6): e31-37, 2009. PMID: 19410035.
103. Ohno T, Katori M, Nishiyama K and Saigenji K. Direct observation of microcirculation of the basal region of rat gastric mucosa. J Gastroenterol 30(5): 557-564, 1995. PMID: 8574325.
104. Omata F, Deshpande G, Tokuda Y, Takahashi O, Ohde S, Carr-Locke DL, et al. Meta-analysis: somatostatin or its long-acting analogue, octreotide, for prophylaxis against post-ERCP pancreatitis. J Gastroenterol 45(8): 885-895, 2010. PMID: 20373114.
105. Otsuka T, Kawazoe S, Nakashita S, Kamachi S, Oeda S, Sumida C, et al. Low-dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a randomized controlled trial. Journal of Gastroenterology: 1-6, 2012. PMID: 22350703.
106. Park KT, Kang DH, Choi CW, Cho M, Park SB, Kim HW, et al. Is high-dose nafamostat mesilate effective for the prevention of post-ERCP pancreatitis, especially in high-risk patients? Pancreas 40(8): 1215-1219, 2011. PMID: 21775918.
107. Patel R, Varadarajulu S and Wilcox CM. Endoscopic ampullectomy: techniques and outcomes. J Clin Gastroenterol 46(1): 8-15, 2012. PMID: 22064552.
108. Petrov MS and Savides TJ. Systematic review of endoscopic ultrasonography versus endoscopic retrograde cholangiopancreatography for suspected choledocholithiasis. Br J Surg 96(9): 967-974, 2009. PMID: 19644975.
109. Rabenstein T, Schneider HT, Bulling D, Nicklas M, Katalinic A, Hahn EG, et al. Analysis of the risk factors associated with endoscopic sphincterotomy techniques: preliminary results of a prospective study, with emphasis on the reduced risk of acute pancreatitis with low-dose anticoagulation treatment. Endoscopy 32(1): 10-19, 2000. PMID: 10691266.
110. Rashdan A, Fogel EL, McHenry L, Jr., Sherman S, Temkit M and Lehman GA. Improved stent characteristics for prophylaxis of post-ERCP pancreatitis. Clin Gastroenterol Hepatol 2(4): 322-329, 2004. PMID: 15067627.
111. Rinderknecht H. Activation of pancreatic zymogens. Normal activation, premature intrapancreatic activation, protective mechanisms against inappropriate activation. Dig Dis Sci 31(3): 314-321, 1986. PMID: 2936587.
112. Romagnuolo J, Bardou M, Rahme E, Joseph L, Reinhold C and Barkun AN. Magnetic resonance cholangiopancreatography: a meta-analysis of test performance in suspected biliary disease. Ann Intern Med 139(7): 547-557, 2003. PMID: 14530225.
113. Rosenblatt ML, Catalano MF, Alcocer E and Geenen JE. Comparison of sphincter of Oddi manometry, fatty meal sonography, and hepatobiliary scintigraphy in the diagnosis of sphincter of Oddi dysfunction. Gastrointest Endosc 54(6): 697-704, 2001. PMID: 11726844.
114. Rudin D, Kiss A, Wetz RV and Sottile VM. Somatostatin and gabexate for post-endoscopic retrograde cholangiopancreatography pancreatitis prevention: Meta-analysis of randomized placebo-controlled trials. Journal of Gastroenterology and Hepatology 22(7): 977-983, 2007. PMID: 17559376.
115. Sagi SV, Schmidt S, Fogel E, Lehman GA, McHenry L, Sherman S, et al. Association of greater intravenous volume infusion with shorter hospitalization for patients with post-ERCP pancreatitis. J Gastroenterol Hepatol 29(6): 1316-1320, 2014. PMID: 24372871.
116. Schwacha H, Allgaier HP, Deibert P, Olschewski M, Allgaier U and Blum HE. A sphincterotome-based technique for selective transpapillary common bile duct cannulation. Gastrointest Endosc 52(3): 387-391, 2000. PMID: 10968855.
117. Senol A, Saritas U and Demirkan H. Efficacy of intramuscular diclofenac and fluid replacement in prevention of post-ERCP pancreatitis. World journal of gastroenterology : WJG 15(32): 3999-4004, 2009. PMID: 19705494.
118. Sethi S, Sethi N, Wadhwa V, Garud S and Brown A. A meta-analysis on the role of rectal diclofenac and indomethacin in the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis. Pancreas 43(2): 190-197, 2014. PMID: 24518496.
119. Shao LM, Chen QY, Chen MY and Cai JT. Nitroglycerin in the prevention of post-ERCP pancreatitis: a meta-analysis. Dig Dis Sci 55(1): 1-7, 2010. PMID: 19160042.
120. Sherman S, Troiano FP, Hawes RH and Lehman GA. Sphincter of Oddi manometry: decreased risk of clinical pancreatitis with use of a modified aspirating catheter. Gastrointest Endosc 36(5): 462-466, 1990. PMID: 1699837.
121. Singh P, Gurudu SR, Davidoff S, Sivak MV, Jr., Indaram A, Kasmin FE, et al. Sphincter of Oddi manometry does not predispose to post-ERCP acute pancreatitis. Gastrointest Endosc 59(4): 499-505, 2004. PMID: 15044885.
122. Singh VK. A Randomized Trial of Rectal Indomethacin and Papillary Spray of Epinephrine Versus Rectal Indomethacin to Prevent Post-ERCP Pancreatitis in High Risk Patients. NCT02116309.
123. Somogyi L, Chuttani R, Croffie J, Disario J, Liu J, Mishkin D, et al. Guidewires for use in GI endoscopy. Gastrointest Endosc 65(4): 571-576, 2007. PMID: 17383455.
124. Sotoudehmanesh R, Eloubeidi MA, Asgari AA, Farsinejad M and Khatibian M. A Randomized Trial of Rectal Indomethacin and Sublingual Nitrates to Prevent Post-ERCP Pancreatitis. The American journal of gastroenterology, 2014. PMID: 24513806.
125. Sotoudehmanesh R, Khatibian M, Kolahdoozan S, Ainechi S, Malboosbaf R and Nouraie M. Indomethacin may reduce the incidence and severity of acute pancreatitis after ERCP. Am J Gastroenterol 102(5): 978-983, 2007. PMID: 17355281.
126. Staritz M, Poralla T, Ewe K and Meyer zum Buschenfelde KH. Effect of glyceryl trinitrate on the sphincter of Oddi motility and baseline pressure. Gut 26(2): 194-197, 1985. PMID: 3917965.
127. Sudhindran S, Bromwich E and Edwards PR. Prospective randomized double-blind placebo-controlled trial of glyceryl trinitrate in endoscopic retrograde cholangiopancreatography-induced pancreatitis. Br J Surg 88(9): 1178-1182, 2001. PMID: 11531863.
128. Sun HL, Han B, Zhai HP, Cheng XH and Ma K. Rectal NSAIDs for the prevention of post-ERCP pancreatitis: A meta-analysis of randomized controlled trials. The surgeon : journal of the Royal Colleges of Surgeons of Edinburgh and Ireland, 2013. PMID: 24332479.
129. Swan MP, Alexander S, Moss A, Williams SJ, Ruppin D, Hope R, et al. Needle knife sphincterotomy does not increase the risk of pancreatitis in patients with difficult biliary cannulation. Clin Gastroenterol Hepatol 11(4): 430-436 e431, 2013. PMID: 23313840.
130. Tarnasky PR, Palesch YY, Cunningham JT, Mauldin PD, Cotton PB and Hawes RH. Pancreatic stenting prevents pancreatitis after biliary sphincterotomy in patients with sphincter of Oddi dysfunction. Gastroenterology 115(6): 1518-1524, 1998. PMID: 9834280.
131. Testoni PA, Testoni S and Giussani A. Difficult biliary cannulation during ERCP: how to facilitate biliary access and minimize the risk of post-ERCP pancreatitis. Dig Liver Dis 43(8): 596-603, 2011. PMID: 21377432.
132. Trap R, Adamsen S, Hart-Hansen O and Henriksen M. Severe and fatal complications after diagnostic and therapeutic ERCP: a prospective series of claims to insurance covering public hospitals. Endoscopy 31(2): 125-130, 1999. PMID: 10223360.
133. Tse F, Liu L, Barkun AN, Armstrong D and Moayyedi P. EUS: a meta-analysis of test performance in suspected choledocholithiasis. Gastrointest Endosc 67(2): 235-244, 2008. PMID: 18226685.
134. Tse F, Yuan Y, Moayyedi P and Leontiadis GI. Guidewire-assisted cannulation of the common bile duct for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. Cochrane Database Syst Rev 12: CD009662, 2012. PMID: 23235679.
135. Vandervoort J, Soetikno RM, Tham TC, Wong RC, Ferrari AP, Jr., Montes H, et al. Risk factors for complications after performance of ERCP. Gastrointest Endosc 56(5): 652-656, 2002. PMID: 12397271.
136. Verma D, Kapadia A, Eisen GM and Adler DG. EUS vs MRCP for detection of choledocholithiasis. Gastrointest Endosc 64(2): 248-254, 2006. PMID: 16860077.
137. Waljee AK and Higgins PD. Machine learning in medicine: a primer for physicians. Am J Gastroenterol 105(6): 1224-1226, 2010. PMID: 20523307.
138. Wang P, Li ZS, Liu F, Ren X, Lu NH, Fan ZN, et al. Risk factors for ERCP-related complications: a prospective multicenter study. Am J Gastroenterol 104(1): 31-40, 2009. PMID: 19098846.
139. Weinberg BM, Shindy W and Lo S. Endoscopic balloon sphincter dilation (sphincteroplasty) versus sphincterotomy for common bile duct stones. Cochrane Database Syst Rev(4): CD004890, 2006. PMID: 17054222.
140. Williams EJ, Taylor S, Fairclough P, Hamlyn A, Logan RF, Martin D, et al. Risk factors for complication following ERCP; results of a large-scale, prospective multicenter study. Endoscopy 39(9): 793-801, 2007. PMID: 17703388.
141. Yoo KS, Huh KR, Kim YJ, Kim KO, Park CH, Hahn T, et al. Nafamostat Mesilate for Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis A Prospective, Randomized, Double-Blind, Controlled Trial. Pancreas 40(2): 181-186, 2011. PMID: 21206331.
142. Yuhara H, Ogawa M, Kawaguchi Y, Igarashi M, Shimosegawa T and Mine T. Pharmacologic prophylaxis of post-endoscopic retrograde cholangiopancreatography pancreatitis: protease inhibitors and NSAIDs in a meta-analysis. J Gastroenterol, 2013
143. Zidi SH, Prat F, Le Guen O, Rondeau Y, Rocher L, Fritsch J, et al. Use of magnetic resonance cholangiography in the diagnosis of choledocholithiasis: prospective comparison with a reference imaging method. Gut 44(1): 118-122, 1999.
144. Zolotarevsky E, Fehmi SM, Anderson MA, Schoenfeld PS, Elmunzer BJ, Kwon RS, et al. Prophylactic 5-Fr pancreatic duct stents are superior to 3-Fr stents: a randomized controlled trial. Endoscopy 43(4): 325-330, 2011.
Now the question arises that can pancreatitis be diagnosed earlier. Regarding this some tests were prescribed in the medical protocol regarding pancreatitis.
Tests and procedures used to diagnose pancreatitis include:
• Blood tests to look for elevated levels of pancreatic enzymes, along with white blood cells, kidney function and liver enzymes • Abdominal ultrasound to look for gallstones and pancreas inflammation • Computerized tomography (CT) scan to look for gallstones and assess the extent of pancreas inflammation • Magnetic resonance imaging (MRI) to look for abnormalities in the gallbladder, pancreas and ducts • Endoscopic ultrasound to look for inflammation and blockages in the pancreatic duct or bile duct • Stool tests in chronic pancreatitis to measure levels of fat that could suggest your digestive system isn t absorbing nutrients adequately Your doctor may recommend other tests, depending on your particular situation.
No such test was performed in the beginning by the opposite party. If appointed parties knew that complication may happen in such cases, it is the duty to test the various pathological examination for other complications so that it can be cured at an early stage. The opposite party has stated in their written statement that as per section, it is widely accepted internationally that the post-operative complications may arise based on human anatomy, and it does not constitute or establish any reasons on the part of performing certain. Now it is better to see the following article.
Postcholecystectomy Abdominal Bile Collections Crystine M. Lee, MD; Lygia Stewart, MD; Lawrence W. Way, MD Author Affiliations Article Information Arch Surg. 2000;135(5):538-544. doi:10.1001/archsurg.135.5.538 Abstract Hypothesis The clinical syndromes caused by bile collections in the abdomen span a wide spectrum and their natural history and risks are not fully appreciated.
Design Analysis of 179 patients with bile fistulas after cholecystectomy, of which 154 patients had undrained bile collections.
Objective To characterize the manifestations and natural history of abdominal bile collections.
Setting A tertiary care teaching hospital.
Patients and Methods The clinical findings in 179 patients with bile fistulas resulting from iatrogenic laparoscopic bile duct injuries and other miscellaneous operations between 1990 and 1999 were analyzed. The group of main interest consisted of 154 patients with undrained bile collections. Of these 154 patients, 21% had serious complications, including sepsis and multiorgan failure. The data were analyzed to identify the variables associated with this undesirable outcome.
Main Outcome Measures Symptoms, physical findings, course of illness, and laboratory and imaging findings.
Results The clinical manifestations of intra-abdominal bile collections were initially discounted in 77% of patients, so the problem went unsuspected for a variable and often lengthy period. Abdominal pain and tenderness (bile peritonitis) gradually developed in 18% of patients with bile ascites. There were no differences in the initial clinical findings in this group compared with those who did not develop peritonitis. Nineteen percent of patients with undrained bile collections experienced serious morbidity. The initial clinical findings did not differ in these patients compared with those with a less complicated illness. Serious illness, however, was associated with the following: (1) a longer period of undrained bile (15.4 vs 9.2 days, P=.04) and (2) a higher incidence of infected bile (45% vs 7%, P=.001).
Conclusions (1) Prominent abdominal pain and tenderness developed in only 21% of patients with abdominal bile collections; (2) the symptoms caused by bile collections were often subtle and their significance was overlooked, which resulted in a delay in diagnosis; (3) the early clinical findings could not distinguish patients who did become critically ill from those who did not; and (4) seriously ill patients more often had delayed drainage and infected bile. Still, failure to drain a bile collection within just 5 days resulted in serious illness in a few patients. Surgeons must watch for the clinical manifestations of bile ascites after laparoscopic cholecystectomy. This diagnosis should be suspected whenever persistent bloating and anorexia last for more than a few days; failure to recover as smoothly as expected is the most common early symptom of bile ascites. If bile collections were promptly diagnosed and drained, the rate of serious illness resulting from this complication would decline.
BILE COLLECTIONS within the peritoneal cavity have various causes, but they most often occur as a manifestation of bile duct injury or some other technical complication of laparoscopic cholecystectomy. Unless drains have been used, a bile leak leads to accumulation of bile in the abdomen. Previous reports have suggested that bile peritonitis, with guarding and rebound tenderness, is the principal manifestation of an abdominal bile collection, but this is actually an uncommon presentation early in the patient s course.1-6 While a few patients do have such clinical findings, most have much milder symptoms, best referred to as bile ascites.7 With the advent of laparoscopic cholecystectomy, the incidence of bile duct injuries, and hence, bile collections in the abdomen, has increased.8,9 This study defines the syndromes associated with abdominal bile collections and shows how best to manage patients with this problem.
Patients and methods One hundred seventy-nine patients with bile fistulas were referred for evaluation to the University of California San Francisco Medical Center between 1990 and 1999. Of these 179 patients, 25 (14%) had a drain placed at the time of the first operation. The other 154 (86%) did not initially have drains placed and developed abdominal bile collections. Of this latter group, 74 had drains placed and 79 did not before a definitive operation was performed to treat the fistula. Twenty-one percent of the patients were men and 79% were women; the average age was 46 years (range, 18-86 years).
Preoperative diagnoses and index operation The preoperative diagnoses were chronic cholecystitis (65%), acute cholecystitis (32%), and miscellaneous (3%). The first, or index, operation was laparoscopic cholecystectomy in 94% of patients, open cholecystectomy in 3%, a nonbiliary operation in 2%, and a complex biliary operation in 1%. In 21% of patients who had a laparoscopic cholecystectomy, the procedure had been converted to an open cholecystectomy to improve exposure (4%), treat a bile duct injury (13%), or perform a common bile duct exploration (4%).
Type and location of biliary injuries The biliary injuries in the patients who underwent a laparoscopic cholecystectomy were classified as follows: class 1, 8% (partial transection of the common bile duct); class 2, 21% (injury to the common hepatic duct due to clips or cautery); class 3, 54% (excision of a portion of the common duct and/or hepatic ducts); and class 4, 15% (damage to the right hepatic duct). The remaining 2% had cystic duct stump leaks (2 patients) or bile leaks from a duct in the liver bed (1 patient).
Definition of terms The following definitions will be adhered to in this article. Abdominal bile collection, sometimes abbreviated as "bile collection," refers to the presence of undrained bile in the abdomen and includes 2 subcategories, bile ascites and bile peritonitis. The term bile ascites is used for bile collections without prominent abdominal pain and tenderness. Bile peritonitis is the term used when a patient with an abdominal bile collection manifests prominent abdominal pain and tenderness. Bile peritonitis, as used herein, does not imply that the bile was infected.
Statistics Using the Statview 5.0 statistical program, the data were analyzed by analysis of variance, the Fisher exact test, or the χ2 test.
Results Clinical presentation Of the 179 patients, 25 (14%) had a drain placed at the index operation that functioned properly, while undrained bile (ie, a bile collection) developed in 154 patients (86%). These 154 patients constitute the group of principal interest in this report, although the 25 patients with drains will also be described. Table 1 gives the symptoms in those with drained and undrained bile fistulas at initial presentation. Cholangitis was initially present in 26% of patients without drains and in 21% of patients with drains (P, not significant); 11% of patients with undrained bile had sepsis, compared with 7% of those whose fistulas were drained (P, not significant).
Bile drainage was often managed expectantly for long periods (average period, 13.9 days; range, 1-45 days) before a diagnostic workup was performed. Even when imaging studies had identified a bile fistula, these patients were followed up for an average of 30.2 days (range, 2-189 days) before a definitive repair was performed. Seventy-one percent of these patients developed symptoms during this period, most likely due to malfunction of the drains; 20% developed serious complications. One patient in this group eventually died of sepsis.
Diagnosis In 23 (13%) cases, the injury was recognized at the index operation. In this situation, the primary surgeon repaired the bile duct immediately (39%), placed drains and instituted nonoperative treatment (36%), or placed drains and transferred the patient to a tertiary care center for biliary reconstruction (25%).
The injury went unrecognized in 156 patients (87%) at the index operation. Of these, 139 (89%) were discharged home without a diagnosis; 25 (18%) of these patients left the hospital with bothersome malaise, anorexia, and nausea that in retrospect warranted more attention. In 35 (25%) of these patients, the diagnosis remained elusive even after the first outpatient checkup. Overall, a symptomatic bile collection was initially missed in 77% of patients; their symptoms were considered nonspecific or insignificant. The mean (± SD) time to diagnosis was 16.8 (25.0) days for all patients with intra-abdominal bile collections.
Bile peritonitis vs bile ascites Only 5 patients (3%) had bile peritonitis as the initial presenting syndrome caused by the bile collection. The incidence of cholangitis (100% vs 25%, P=.04), sepsis (100% vs 6%, P=.004), and leukocytosis (16.2 × 109 vs 12.6 × 109, P=.03) was greater in those who initially presented with peritonitis compared with those who did not.
Patients with bile ascites who ultimately developed bile peritonitis had a higher incidence of malaise and abdominal discomfort (Table 2). Fever, abdominal tenderness, and jaundice were initially found in 45% of patients who developed bile peritonitis and in only 3% of patients who did not (P .001). Cholangitis was initially present in 36% of patients who later developed bile peritonitis and 21% of patients who did not (P, not significant). Laboratory findings were not different and the time to diagnosis was not different between the 2 groups (Table 2).
Bile in the abdomen The mean (± SD) amount of bile recovered when drains were inserted into the bile collections was 713 (901) mL. The amount was substantially larger in patients who developed bile peritonitis than in those with only bile ascites (Table 2). Bile collections greater than 500 mL were present in 79% of patients with bile peritonitis and in 13% of patients with bile ascites (P=.002). Drainage had not been instituted in 42% of patients within 7 days of the index operation and in 19% within 14 days of the index operation.
Patients with serious complications Twenty-one patients with bile collections had 1 or more of the following serious complications: sepsis (10%), abscess formation (11%), pancreatitis (3%), respiratory failure (3%), gastrointestinal bleeding (1%), transdiaphragmatic bile fistula formation (1%), necrotizing fasciitis (1%), pulmonary embolism (1%), and stroke (1%). Cholangitis developed in 25% of patients with these other serious complications. Two patients died of sepsis and multiorgan system failure.
The initial clinical presentation was not different between those who developed serious complications and those who did not. Patients with serious complications had undrained bile present for 15.4±19.1 days, while those without serious complications had undrained bile for 9.2±10.7 days (P=.045). Serious complications developed in 45% of patients with infected bile compared with 7% of those with uninfected bile (P .001). Severe complications were not confined to patients whose bile was allowed to go undrained for long periods: 4 patients with undrained bile developed severe complications within 5 days of the index operation.
Early vs late drainage The clinical course of patients whose bile collection was drained early ( 10 days after cholecystectomy) was compared with those whose collection was drained late (≥10 days after cholecystectomy) (Table 3). Fifty-four percent of patients whose bile was drained 10 days after their cholecystectomy had fever, compared with 29% of those whose bile was drained less than 10 days after their cholecystectomy (P=.01). Infected fluid collections were more commonly found in patients whose bile was drained late (28%) than in those whose bile was drained early (7%) (P=.008).
Imaging and percutaneous drainage The diagnosis of a bile fistula was made by observation of bile drainage from drains placed at the index operation (13%) or the wound (1%), or discovery of a fluid collection on ultrasound, computed tomographic (CT) scan, or HIDA scan (86%). Ultrasound scanning (69%) was the imaging test most commonly ordered, followed by CT (55%) and HIDA scans (39%). Computed tomography was the most sensitive (Table 4). The sensitivity for detecting intra-abdominal bile collections was 70% and 64%, respectively, for ultrasound and HIDA scans (Table 4). To define the biliary anatomy, a percutaneous transhepatic cholangiography was obtained in 73% of cases and endoscopic retrograde cholangiopancreatography (ERCP) in 70%. The sensitivity of percutaneous transhepatic cholangiography for detecting abnormalities was 100%, and for ERCP, 98%. While a successful ERCP was sensitive, the success rate for achieving a technically adequate study was only 87%. An exploratory laparotomy was performed (rather than percutaneous drainage) just to drain the bile collection in 14% of patients. Because these patients all had bile duct injuries, this strategy subjected these patients to 2 laparotomies instead of 1, as a second procedure was required later to repair the bile duct injury.
Comment Most cholecystectomies are now done laparoscopically. While this is associated with less discomfort and shorter hospital stays, the incidence of bile duct injuries is more common than with open cholecystectomy.9 Bile accumulates in the abdomen in most patients with bile duct injuries because the injury most often results in a fistula that goes undetected and undrained during the original operation. Our data show that the symptoms caused by bile collections were often quite subtle. Most patients with bile collections did not present with peritonitis; instead, they had bile ascites, with mild, relatively nonspecific symptoms. Consequently, the presence of a bile collection and associated biliary injury often went unsuspected for a time until symptoms worsened and delays in diagnosis and treatment allowed bile peritonitis and serious illness to develop. Among our series, the correct diagnosis was missed initially in 77% of patients.
We could identify no criteria that allowed one to predict which patients with bile ascites would develop peritonitis. Furthermore, unlike what is widely believed, the presence of peritonitis did not predict which patients would develop serious complications. In fact, many of the patients who became seriously ill never passed through a phase that included prominent abdominal pain and tenderness. In short, it was not possible to distinguish those who would become critically ill from those who would not based on the early clinical presentation. Thus, following the abdominal findings as a strategy for determining the course of the illness was unreliable. Everyone with undrained bile was at risk.
Even when bile was issuing from a drain, the patient was sometimes managed nonoperatively for periods as long as 6 months. The presence of a drain did not guarantee that a bile collection would be avoided; drains can malfunction. Therefore, CT scans should be obtained early in the management of a patient with an unplanned external bile fistula, more or less routinely, to check on the adequacy of drainage.
Some patients in this review were known from imaging studies to have intra-abdominal bile collections, but they were followed up expectantly with the expressed hope that the bile would be reabsorbed from the abdominal space. Nevertheless, reabsorption of bile collections larger than 4 cm was rare and unpredictable. Furthermore, there is no support for such a treatment strategy in the literature.1-8 As this and other studies show,1-8 the morbidity and mortality rates can be high in patients with undrained bile collections. Because morbidity is greater the longer treatment is delayed, physicians caring for these patients must have a high index of suspicion for a biliary injury, learn to recognize the clinical features of bile ascites, even when mild, and investigate and treat patients who have these symptoms.
The evidence suggests that if bile collections were never drained, most patients would eventually become gravely ill from superinfection. The following factors correlated with a worse outcome: length of time bile was left in the abdomen and the development of superinfection. Animal research has shown that (1) bile salts are the toxic component of bile, (2) large amounts of bile in the abdomen can be rapidly lethal, (3) mortality is greater if the bile is infected, (4) and the natural history of sterile bile in the abdomen is that it eventually becomes infected.10-15 Our clinical data agree with these experimental observations. The longer the bile collections were left undrained, the greater the incidence of severe illness, including sepsis. Late drainage was more commonly associated with positive bile cultures.
In conclusion, we recommend adoption of a high index of suspicion for biliary tract injury in postcholecystectomy patients who have anything less than a smooth postoperative course. Vigilance should be high for the initially subtle manifestations of bile in the abdomen. Diagnostic imaging is called for even in the absence of pain, fever, leukocytosis, or abdominal tenderness. While positive findings are important, absence of expected positive findings (eg, fever or leukocytosis) is common and does not diminish the significance of the positive findings.
An abdominal CT scan should be obtained in patients who have a syndrome suggestive of bile ascites, especially after laparoscopic cholecystectomy. We are concerned about the treatment delays that followed false-negative HIDA scans, and can find no role for this test in this situtation. We favor CT over ultrasound scans as the imaging test of choice. Once the presence of intra-abdominal fluid has been confirmed by CT scan, the fluid should be percutaneously drained and cultured while the patient is still in the scanner. It is unnecessary and undesirable to perform an exploratory laparotomy solely to diagnose or drain an abdominal bile collection. Percutaneous drainage can be as thorough, and it avoids the morbidity of a laparotomy.
After a bile collection has been evacuated by drains, ERCP and percutaneous transhepatic cholangiography should be performed to define completely the cause of the bile leak and the anatomy of the biliary tree.8 Then, a specific operative treatment plan can be devised. We have previously discussed the treatment of biliary injures in detail.8 In general, cystic duct and liver bed leaks can be treated by percutaneous drainage of bile collections and endoscopic placement of a temporary biliary stent. Class 1 bile duct injuries should be treated by laparotomy and closure of the defect in the duct using fine (eg, 6-0) monofilament absorbable suture material such as Maxon (US Surgical Corp, Norwalk, Conn). There is no need for a T tube, which just adds further trauma to the duct. Class 2, 3, and 4 injuries should be treated by debridement of devitalized tissue in the hilum of the liver, mobilization of a short (ie, 5 mm) segment of the injured duct, excision of devitalized tissue at the end of the duct, followed by a Roux-en-Y hepaticojejunostomy. The anastomosis should be done in 1 layer using fine (ie, 6-0, 5-0, or 4-0), absorbable, monofilament suture. End-to-end repairs of injured bile ducts are rarely successful.
The important point of this study is that once a bile collection has been drained, the major potential for immediate serious illness has usually been eliminated. This allows the injury to be fully delineated and treatment to be planned and carried out in an unhurried manner.
Presented at the 107th Scientific Session of the Western Surgical Association, Santa Fe, NM, November 16, 1999.
Corresponding author: Lawrence W. Way, MD, 513 Parnassus Ave, Room S-550, San Francisco, CA 94143-0475 (e-mail: [email protected]).
References
1. Crowley LLHarkins HN Perforation of the gallbladder: a study of 25 consecutive cases. Surg Gynecol Obstet. 1943;77661- 668
2. Essenhigh DM Perforation of the gallbladder. Br J Surg. 1968;55175- 178
3. Lilly JRWeitraub WHAltman RP Spontaneous of the extrahepatic bile ducts and bile peritonitis in infancy. Surgery. 1974;75664- 673
4. Corbett CRRFyfe NCMNicholls RJJackson BT Bile peritonitis after removal of T-tubes from the common duct. Br J Surg. 1986;73641- 643
5. Morse LKrynski BWright AB Acute perforation of the gallbladder. Am J Surg. 1957;94772- 775
6. Ellis HCronin K Bile peritonitis. Br J Surg. 1960;48166- 171
7. Ackerman NBSillin LFSuresh K Consequences of intraperitoneal bile: bile ascites versus bile peritonitis. Am J Surg. 1985;149244- 246
8. Stewart LWay LW Bile duct injuries during laparoscopic cholecystectomy: factors that influence the results of treatment. Arch Surg. 1995;1301123- 1128
9. Deziel DJ Millikan KWEconomou SGDoolas AKo ST Airan MC Complications of laparoscopic cholecystectomy: a national survey of 4292 hospitals and analysis of 77,604 cases. Am J Surg. 1993;1659- 15
10. Conn JHChaver CMFain WR Bile peritonitis: an experimental and clinical study. Ann Surg. 1970;36219- 224
11. Rosato EFBerkowitz HDRoberts B Bile ascites. Surg Gynecol Obstet. 1970;130494- 496
12. Miles RMJeck HS Observations on experimental bile peritonitis. Surgery. 1953;34445- 456
13. Harkins HNHarmon PHHudson JE Lethal factors in bile peritonitis. Arch Surg. 1936;33576- 609
14. Ravdin ISMorrison MESmyth CM Bile peritonitis and bile ascites. Ann Surg. 1929;89967- 877
15. Santschi DRHuizenga KAScudamore HH et al. Bile ascites. Arch Surg. 1963;87163- 167 Dr Way: A main point is that surgeons expect bile in the abdomen to always produce clinical peritonitis, meaning pain and tenderness. Although bile uniformly produces histologic peritonitis, the clinical findings can range from almost no pain to severe pain. The reason for the differences from patient to patient is unknown. Thus, abdominal pain and tenderness are insensitive criteria for making the diagnosis of bile in the abdomen; for an unpredictable period, pain and tenderness are absent in most patients. In this report we have referred to abdominal bile collections without severe symptoms as bile ascites, regardless of whether the collection was localized or diffuse. Because there is risk of miscommunication unless words are used in the same way, we defined them precisely in the article.
Because the data were collected retrospectively, does this affect the validity of the conclusions? On the contrary. Retrospective data collection is a positive feature of the study. First, it would probably be impossible to conduct a study like this prospectively, but that is not the point. The advantage of the retrospective aspect is that the analysis is based on statements in the hospital records that preserve the thoughts of those caring for the patients at the moment. The character of these statements would be quite different if collected as part of a prospective study. In that case, the data would not accurately reflect existing surgical practice.
About 20% of patients had drains in places other than the right upper quadrant. The volume of bile obtained on the initial catheterization varied from about 100 mL to several liters, and the greater the volume, the more likely additional drains would be needed. The right upper quadrant drained most of the bile. If a second drain was required, it was usually in the pelvis.
The serum bilirubin level only loosely correlated with the volume of bile in the abdomen. Bilirubin levels rise because of reabsorption of bilirubin from the abdomen. They rarely exceeded 2 to 5 mg because the liver eliminates extra bilirubin according to first-order kinetics (the higher the serum bilirubin concentration, the greater the bilirubin load excreted). Because bilirubin levels remained so low, they were often dismissed as clinically insignificant.
We were dealing with a skewed population in the sense that there were few patients with leaks from the cystic duct stump or gallbladder bed. Nevertheless, the conclusions are unaffected. The principal misconceptions identified in this study are that a collection of bile (1) always produces severe pain and (2) can be left untreated as long as the patient looks and feels well. These assumptions are false regardless of the source of the leak.
In treating leaks of the cystic duct stump or the liver bed, one should not rely entirely on a bile duct stent placed at ERCP if there is also an abdominal accumulation of bile, as there usually is. Counterdrainage is indicated or serious infection may develop. Just because a bile duct stent alone has worked a few times does not mean that it will the next time. One patient who was brought to our attention, who was not part of this study, died solely because the importance of removing the abdominal bile had not been recognized. Drains placed at the index operation usually worked well.
The presence of an abdominal bile collection does not always mean a bile duct injury has occurred, but if the collection is greater than 4 cm, one should assume that there is a significant leak until an ERCP proves otherwise. From our retrospective vantage point, the surgeon remained convinced for too long that the operation was uncomplicated in many cases of leaks.
In this series, HIDA scans were misleading for the diagnosis of a bile leak and, too often, a false-negative study incorrectly suppressed tentative concerns about a possible leak. Although accurate in some cases, HIDA scans overlooked many significant leaks. Furthermore, when a HIDA scan was positive, another imaging test (ie, CT or ultrasound scan) had to be done to insert drains into the collection. Therefore, a negative HIDA scan was unreliable, and a positive scan required the alternative study anyway.
So it is clear that this bile collection most often occur as a manifestation of bile duct injury or some other technical complication of laparoscopic cholecystectomy.
The gallbladder sits under the liver on the right side of your abdomen; it stores bile. If bile duct injuries happen during surgery, the first goal is to manage any infection, leakage or blockage. Sometimes second surgeries are needed.
What is the gallbladder?
The gallbladder is a small, sac-like organ that sits under the liver on the right side of your abdomen (belly). The gallbladder stores a greenish fluid called bile. Bile is made and released by the liver and then sent to the small intestine, where it helps the body break down and absorb food. Bile moves through a network of tube-like structures called bile ducts.
Why would I need gallbladder surgery?
Sometimes, small, hard masses called gallstones form inside the gallbladder. These stones can cause swelling, pain, and infection. Gallstone disease is one of the most common digestive system disorders. It is the most common reason for gallbladder surgery. Surgery to remove a diseased gallbladder is called a cholecystectomy. You can live normally without a gallbladder, but you might need to make some changes in your diet.
A common type of gallbladder surgery, called laparoscopic cholecystectomy, is done through a few small cuts in the abdomen. For this type of surgery, a camera and light are attached to a scope and are placed into one of the small cuts. The camera projects a live-action video of the inside of the abdomen onto a screen near the surgical table. The doctor looks at the screen and uses the video to guide his or her movements. The doctor then takes out the gallbladder with surgical tools placed in the other small cuts. Benefits of laparoscopic cholecystectomy over open surgery include less pain, less time in the hospital and quicker recovery. It is now considered the "gold standard" for surgical treatment of gallbladder disease.
What is a bile duct injury?
A bile duct injury is damage to the bile ducts that happens during gallbladder surgery. A bile duct can get cut, burned, or pinched. As a result of an injury, the bile duct will not be able to work right, leaking bile into the abdomen or blocking the normal flow of bile from the liver. Bile duct injuries lead to symptoms that can be painful, even deadly, if not treated.
How common are bile duct injuries during gallbladder surgery?
The numbers vary by study. Some estimate that bile duct injuries occur in 1 in 1,000 cases of laparoscopic gallbladder surgery. They appear to occur less often in open surgeries.
SYMPTOMS AND CAUSES What causes bile duct injuries during gallbladder surgery?
Most bile duct injuries that occur during gallbladder surgery happen because the area around the gallbladder and bile ducts is masked in some way so that the doctor cannot see it clearly. This can happen if the area s structure (anatomy) is different than normal, or if there is a lot of bleeding, swelling, or scarring in the area.
How will I know if I have a bile duct injury?
Some bile duct injuries are found by the doctor at the time of surgery. If not, the first sign of a bile duct injury is failing to recover quickly after the procedure. Other symptoms might include:
• Fever.
• Chills.
• Nausea and vomiting.
• Abdominal pain.
• Swelling of the abdomen.
• General discomfort.
• Jaundice (yellowing of the skin and the whites of the eyes).
DIAGNOSIS AND TESTS How are bile duct injuries that happen during gallbladder surgery diagnosed?
In about 10% to 30% of cases, bile duct injuries are found by the doctor at the time of surgery. He or she might notice leaking bile or a blockage by sight or by using a test called intraoperative cholangiography (IOC). IOC is an X-ray exam of the bile ducts after a dye has been injected to make the flow of bile clearly visible on the X-ray image.
If your injury was not found during surgery, tests your doctor might use to help diagnose a bile duct injury include:
• Transabdominal ultrasound: This test uses sound waves and echoes to create images of the organs in the abdomen.
• Endoscopic retrograde cholangiopancreatography (ERCP): This test uses a lighted, flexible scope inserted into the upper part of the digestive system to look at and take X-rays of the bile ducts. Sometimes, bile duct injuries can also be treated using ERCP.
• Percutaneous transhepatic cholangiography: Like IOC, during this test, X-rays are taken after dye is injected into the bile ducts.
• Magnetic resonance cholangiopancreatography (MRCP): This test uses magnetic resonance imaging, which uses a large magnet and radio waves to create images of the inside of the body, to view the bile ducts.
MANAGEMENT AND TREATMENT How are bile duct injures treated?
The first goal of treatment is to manage any infection, leakage, or blockage caused by the injury. Then, the doctor may need to reconstruct the bile duct, often using a piece of intestine to bypass the blockage or the area where the duct was cut or burned.
In some cases, if the doctor finds the bile duct injury during surgery, he or she is able to repair it at that time. In other cases, if the injury is complex, it might require a second surgery by a specially trained doctor.
PREVENTION Can bile duct injuries during gallbladder surgery be prevented?
Some doctors think that using IOC more often will help reduce the number, or severity, of bile duct injuries, while other doctors believe that not all injuries can be prevented, even with IOC. Other doctors suggest that changes in how the surgery is performed and the equipment used will reduce the number of injuries. However, not all bile duct injuries can be prevented, so they remain a possible risk of gallbladder surgery.
OUTLOOK / PROGNOSIS What is the outcome for patients with bile duct injuries?
The outcome depends on the type and extent of the injury and how soon the injury is found. Most bile duct injuries can be successfully repaired, and the patient can go on to have a good quality of life. In severe cases, with more than one surgery, many months of recovery might be needed.
A note from Cleveland Clinic Call your healthcare provider if you don t begin to feel better a few days after gallbladder surgery or if you begin to experience any of the symptoms of a bile duct injury. Keep in mind that some of the symptoms might not affect you right away. The effects of a bile duct injury might not be obvious until weeks after your surgery.
So it is clear that in about 10% to 30% of cases, bile duct injuries are found by the doctor at the time of surgery. He or she might notice leaking bile or a blockage by sight or by using a test called intraoperative cholangiography (IOC). IOC is an X-ray exam of the bile ducts after a dye has been injected to make the flow of bile clearly visible on the X-ray image. Why this test was not performed by the opposite party when they knew that bile duct injury might happen in such a laparoscopic course. The doctor should be vigilant and he should know that what consequences may follow and for this they should be ready for the diagnosis and treatment at the earliest. When they knew the symptoms of bile duct injury, proper care should have been taken by them just after the laparoscopic cholecystectomy. In this case it has not been done showing their negligence at the very beginning. It also shows the lack of post-operative care in the hospital.
The another thing is also important is post-operative care. After surgery or any such process, the patient should not be discharged immediately but he should be kept in the ward for post-operative care at least for one or two-days so that the concerned Dr May know what the problem may be faced by the patient. In laparoscopic cholecystectomy, the doctor knows that complication may arise such as bile duct leakage. So it was his duty to keep the patient in the hospital for post-operative care. Post-operative care is very necessary in such cases. We have seen the post-operative care by the following medical article.
Immediate postoperative care:
Now an action arises whether there was proper post-operative care taken by the opposite parties after the operation and after the complication developed in the body of the patient.
Postoperative patients must be monitored and assessed closely for any deterioration in condition and the relevant postoperative care plan or pathway must be implemented.
The NCEPOD (2011) report found that patients whose condition was deteriorating were not always identified and referred for a higher level of care. Patients should be made ascomfortable as possible before postoperative checks are performed.
Postoperative patients are at risk of clinical deterioration, and it is vital that this is minimized. Knowledge and understanding of the key areas of risk and local policies will help reduce potential problems (National Patient Safety Agency, 2007; National Institute for Health and Clinical Excellence, 2007).
Track and trigger or early warning systems are widely used in the UK to identify deteriorating patients. These have been adapted by trusts for adults and children and are based on the patient s pulse and respiratory rate, systolic blood pressure, temperature and level of consciousness. Additional monitoring may include pain assessment, capillary refill time, percentage of oxygen administered, oxygen saturation, central venous pressure, infusion rates and hourly urine output.
The National Early Warning Score (NEWS) was developed by a working party to provide a national standard for assessing, monitoring and tracking acutely and critically ill patients (not for use with children under 16 years or in pregnancy); the intention was that trusts would use it to replace their locally adapted early warning systems (Royal College of Physicians, 2012). Like other early warning systems, NEWS has six physiological parameters:
• Respiratory rate;
• Oxygen saturation;
• Temperature;
• Systolic blood pressure;
• Pulse rate;
• Level of consciousness (this will be impaired in patients who have had recent sedation or are receiving opioid analgesia, which should be taken into consideration in assessment).
The system also includes a weighting score of two, which is added if the patient is receiving supplemental oxygen via a mask or nasal cannulas.
When assessing the postoperative patient using NEWS, it is vital that the patient is observed for signs of hemorrhage, shock, sepsis and the effects of analgesia and anesthetic. Patients receiving intravenous opiates are at risk of their vital signs and consciousness levels being compromised if the rate of the infusion is too high. It is therefore imperative that the patient s pain control is managed well, initially by the anesthetist and then the ward staff and pain team or anesthetist, to ensure that the patient has adequate analgesia but is alert enough to be able to communicate and cooperate with clinical staff in the postoperative period.
Many trusts have yet to implement NEWS, although it is beginning to be taught in pre-registration nursing programmes. Student nurses frequently perform postoperative observations under the supervision of a nurse; it is reassuring that they receive some insight and education as recommended by NCEPOD (2011).
Vital signs;
Vital signs should be performed in accordance with local policies or guidelines and compared with the baseline observations taken before surgery, during surgery and in the recovery area.
Nurses should also be aware of the parameters for these observations and what is normal for the patient under observation. When assessing patients recovery from anaesthesia and surgery, these observations should not be considered in isolation; the nurse should look at and feel the patient. This also applies to children and should include observation of other signs and symptoms, for example abdominal tenderness or poor urine output, which could indicate deterioration (Royal College of Nursing, 2011). The RCN (2011) provides guidance on vital signs performed post-operatively on children. Many trusts now insist that vital signs are performed manually to provide more accurate recording and assessment.
All vital signs and assessments should be recorded clearly in accordance with guidelines for record keeping (Nursing and Midwifery Council, 2009). Handheld personal digital assistants (PDAs) are used at some trusts to store track and trigger data and calculate early warning scores, which can be accessed by the clinical and outreach teams.
When a patient s condition is identified as deteriorating, this information can be passed verbally to appropriate health professionals using the Situation, Background, Assessment and Recommendation (SBAR) tool advocated by the NHS Institute for Innovation and Improvement (2008).
Airway and respirations Respiratory rate and function is often the first vital sign to be affected if there is a change in cardiac or neurological state. It is therefore imperative that this observation is performed accurately; however, studies show it is often omitted or poorly assessed (NPSA, 2007; NCEPOD, 2005).
Nurses should observe and record the following:
• Airway;
• Respiratory rate (regular and effortless), rhythm and depth (chest movements symmetrical);
• Respiratory depression: indicated by hypoventilation or bradypnoea, and whether opiate-induced or due to anaesthetic gases.
Oxygen therapy Oxygen is administered to enable the anaesthetic gases to be transported out of the body, and is prescribed when patients have an epidural, patient-controlled analgesia or morphine infusion. Nurses should ensure and record the following:
• Oxygen therapy is prescribed;
• Oxygen is administered at correct rate;
• Continuous oxygen therapy is humidified to prevent mucous membranes from drying out;
• The skin above the ears is protected from elastic on the mask.
Pulse oximetry Oxygen saturation should be above 95% on air, unless the patient has lung disease, and maintained above 95% if oxygen therapy is prescribed to prevent hypoxia or hypoxaemia. An abnormal recording may be due to shivering, peripheral vasoconstriction or dried blood on the finger.
Nurses should ensure that:
• The finger probe is clean;
• The position of the probe is changed regularly to prevent fingers becoming sore.
• Heart rate, blood pressure and capillary refill time The following should be checked and recorded:
• Rate, rhythm and volume of pulse;
• Blood pressure;
• Capillary refill time to assess circulatory status, along with the colour and temperature of limbs, also identifying reduced peripheral perfusion.
Particular attention should be paid to the systolic blood pressure as a lowered systolic reading and tachycardia may indicate haemorrhage and/or shock, although initially the blood pressure may not drop and will remain within normal limits as the body compensates. Tachycardia may also indicate that the patient is in pain, has a fluid overload or is anxious. Hypertension can be due to the anaesthetic or inadequate pain control.
Body temperature Children, older adults and patients who have been in theatre for a long period are at risk of hypothermia. Shivering can be due to anaesthesia or a high temperature indicative of an infection, while a drop in temperature might indicate a bacterial infection or sepsis.
Patients temperature should be monitored closely and action taken to return it to within normal parameters.
• Use a Bair Hugger (forced-air blanket) and blankets to warm the patient if their temperature is too low;
• Choose an appropriate method to cool the patient if their temperature is too high (antipyretics/fanning/ tepid sponging).
Level of consciousness .
Postoperative patients should respond to verbal stimulation, be able to answer questions and be aware of their surroundings before being transferred to the ward and throughout the postoperative period.
A change in the level of consciousness can be a sign that the patient is in shock. The AVPU scale (Box 2) is appropriate for assessing consciousness in adults, children and young people unless they have had neurosurgery (RCN, 2011).
Fluid balance The NCEPOD (2011) found, in 30% of patient data reviewed, there was insufficient recording of postoperative fluid balance. Nurses should observe/undertake and record on the fluid balance chart the following:
• IV fluids (colloids and crystalloids used to replace fluid loss postoperatively) and infusions;
• Oral intake;
• Urine output: catheter urine measurements should not be less than 0.5ml/kg/hour. Oliguria can be a sign of hypovolaemia and should be reported to medical staff immediately. Check that the catheter is not kinked or that the patient is not lying on the tubing if urine output is reduced;
• Colour of stoma (where appropriate) and whether there is any bleeding;
• Nausea and vomiting: if necessary, administration of antiemetics should be checked and vomit bowls and tissues should be within easy reach of the patient;
• Oral care;
• Nasogastric tube drainage (aspirate if patient feels nauseous unless otherwise indicated);
• Colour and amount of wound drainage: large amounts of fresh blood could be an indication of haemorrhage; if there is no wound drainage, it is advisable to check that the drain has not fallen out.
Intravenous infusions The RCN (2010) and Health Protection Scotland (2012) recommend that peripheral venous catheters (PVC) are checked daily as a minimum, and consideration given to removing any PVC that has been in situ longer than 72 hours (Health Protection Scotland, 2012) or 72-96 hours (Department of Health, 2011).
A phlebitis scale can be used to help assess the PVC site; the Visual Infusion Phlebitis Scale (Jackson, 1998) is frequently used and recommended by the RCN (2010). These national guidelines should be used as resources in caring for PVCs. The following should be checked and recorded:
• The PVC site when changing IV fluids, before administering IV medication;
• Signs of phlebitis (redness, heat and swelling).
Conclusion The postoperative healthcare team is under constant pressure to discharge patients quickly. This can lead to vital signs being missed and result in a delay in recovery.
Patients can be discharged quickly only when they do not experience any post-operative complications, many of which can be avoided or identified with correct and thorough monitoring of signs and symptoms.
All health professionals must continually update their theoretical knowledge and clinical skills; those working in post-operative care can do this by relying less on electronic equipment and developing their ability to combine the use of assessment tools with good observational skills; feeling, listening for abnormal sounds and closely observing their patients.
There are guidelines issued by World Health Organisation for Post Operative Care - these are Postoperative care Post operative note and orders The patient should be discharged to the ward with comprehensive orders for the following:
• Vital signs • Pain control • Rate and type of intravenous fluid • Urine and gastrointestinal fluid output • Other medications • Laboratory investigations The patient s progress should be monitored and should include at least:
• A comment on medical and nursing observations • A specific comment on the wound or operation site • Any complications • Any changes made in treatment Aftercare: Prevention of complications • Encourage early mobilization:
o Deep breathing and coughing o Active daily exercise o Joint range of motion o Muscular strengthening o Make walking aids such as canes, crutches and walkers available and provide instructions for their use • Ensure adequate nutrition • Prevent skin breakdown and pressure sores:
o Turn the patient frequently o Keep urine and faeces off skin • Provide adequate pain control Discharge note On discharging the patient from the ward, record in the notes:
• Diagnosis on admission and discharge • Summary of course in hospital • Instructions about further management, including drugs prescribed.
Ensure that a copy of this information is given to the patient, together with details of any follow-up appointment .
(WHO/EHT/CPR: WHO Surgical Care at the District Hospital 2003 Postoperative Management) If the patient is restless, something is wrong.
Look out for the following in recovery:
• Airway obstruction • Hypoxia • Haemorrhage: internal or external • Hypotension and/or hypertension • Postoperative pain • Shivering, hypothermia • Vomiting, aspiration • Falling on the floor • Residual narcosis The recovering patient is fit for the ward when:
• Awake, opens eyes • Extubated • Blood pressure and pulse are satisfactory • Can lift head on command • Not hypoxic • Breathing quietly and comfortably • Appropriate analgesia has been prescribed and is safely established (WHO/EHT/CPR: WHO Surgical Care at the District Hospital 2003 ) Post operative pain relief • Pain is often the patient s presenting symptom. It can provide useful clinical information and it is your responsibility to use this information to help the patient and alleviate suffering.
• Manage pain wherever you see patients (emergency, operating room and on the ward) and anticipate their needs for pain management after surgery and discharge.
• Do not unnecessarily delay the treatment of pain; for example, do not transport a patient without analgesia simply so that the next practitioner can appreciate how much pain the person is experiencing.
Pain management is our job.
Pain Management and Techniques • Effective analgesia is an essential part of postoperative management.
• Important injectable drugs for pain are the opiate analgesics. Nonsteroidal antiinflammatory drugs (NSAIDs), such as diclofenac (1 mg/kg) and ibuprofen can also be given orally and rectally, as can paracetamol (15 mg/kg).
• There are three situations where an opiate might be given: o Preoperatively o Intraoperatively o Postoperatively • Opiate premedication is rarely indicated, although an injured patient in pain may have been given an opiate before coming to the operating room.
• Opiates given pre- or intraoperatively have important effects in the postoperative period since there may be delayed recovery and respiratory depression, even necessitating mechanical ventilation.
• Short acting opiate fentanyl is used intra-operatively to avoid this prolonged effect.
• Naloxone antagonizes (reverses) all opiates, but its effect quickly wears off.
• Commonly available inexpensive opiates are pethidine and morphine.
• Morphine has about ten times the potency and a longer duration of action than pethidine.
(continued next page) WHO/EHT/CPR: WHO Surgical Care at the District Hospital 2003) Post operative pain relief (continued) • Ideal way to give analgesia postoperatively is to:
o Give a small intravenous bolus of about a quarter or a third of the maximum dose (e.g. 25 mg pethidine or 2.5 mg morphine for an average adult) o Wait for 5-10 minutes to observe the effect: the desired effect is analgesia, but retained consciousness o Estimate the correct total dose (e.g. 75 mg pethidine or 7.5 mg morphine) and give the balance intramuscularly.
o With this method, the patient receives analgesia quickly and the correct dose is given • If opiate analgesia is needed on the ward, it is most usual to give an intramuscular regimen:
¾ Morphine: - Age 1 year to adult: 0.1-0.2 mg/kg - Age 3 months to 1 year: 0.05-0.1 mg/kg ¾ Pethidine: give 7-10 times the above doses if using pethidine • Opiate analgesics should be given cautiously if the age is less than 1 year. They are not recommended for babies aged less than 3 months unless very close monitoring in a neonatal intensive care unit is available.
The complexity of the human body and the uncertainty involved in the medical procedure are of such great magnitude that it is impossible for a Doctor to guarantee a successful result; and the only assurance that he can give, or can be understood to have given by implication is that he is possessed of requisite skill in that branch of profession which he is practising and while undertaking the performance of the task entrusted to him, he would be exercising his skills with reasonable competence. An ordinary physician or surgeon is not expected to be either a clodhopper or feckless practitioner of profession, as much as, he is not expected to be a paragon, combining qualities of polymath or prophet as in the realm of diagnosis and treatment, there is ample scope for genuine difference of opinion; and a Doctor cannot be treated as negligent merely because his conclusion differs from that of other persons in the profession, or because he has displayed less skill or knowledge than others would have shown. The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of, if acting with ordinary care.
Furthermore, a golden principle of law has been laid down by the Hon ble Apex Court in Jacob Mathew Vs. State of Punjab, (AIR 2005 SC 3180) that no sensible professional would intentionally commit an act or omission which would result in loss or injury to the patient as the professional reputation of the person is at stake. A single failure may cost him dear in his career. Even in civil jurisdiction, the rule of res ipsa loquitor is not an universal application and has to be applied with extreme care and caution to the cases of professional negligence and in particular that of the doctors, else it would be counter productive. Simply because a patient has not favourably responded to a treatment given by a physician or a surgery has failed, the doctor cannot be held liable per-se by applying the doctrine of res ipsa loquitor.
Yet, another golden principle of law has been laid down by the Hon ble Apex Court in Indian Medical Association Vs. V.P. Santha s III (1995) CPJ 1 (SC) at para 37 that "it is no doubt true that sometimes complicated questions requiring recording of evidence of experts may arise in a complaint about deficiency in service based on the ground of negligence in rendering medical services by a medical practitioner; but this would not be so in all complaints about deficiency rendering services by a medical practitioner. There may be cases which do not raise such complicated questions and the deficiency in service may be due to obvious faults which can be easily established such as removal of the wrong limb or the performance of an operation on the wrong patient or giving injection of a drug to which the patient is allergic without looking into the out patient card containing the warning or use of wrong gas during the course of an anaesthetic or leaving inside the patient swabs or other items of operating equipment after surgery.
Furthermore, it has been observed in Malay Kumar Ganguli s case (AIR 2010 SC 1162) that" charge of professional negligence on a medical person is a serious one as it affects his professional statusand reputation and as such, the burden of proof would be more onerous. A doctor cannot be held negligent only because something has gone wrong. He also cannot be held liable for mischance or misadventure or for an error in judgment in making a choice when two options are available. The mistake in diagnosis is not necessarily a negligent diagnosis." In the instant matter, thus a simple test, in the light of aforesaid observations, needs to be conducted in order to ascertain whether the Doctor is guilty of any tortious act of negligence/battery amounting to deficiency in conducting a surgery in the delivery of child and not properly attending the patient, the complainant and consequently, liable to pay damages for leaving cotton mass in the abdomen / stomach due to failure in surgery and deteriorating condition of the patient.
Now, it is required to be seen whether an expert report is necessary in each and every case relating to medical negligence or not ?
It has been observed by the Hon ble Apex Court in Indian Medical Association Vs. V.P. Santha III (1995) CPJ 1 (SC) at para 37 that "it is no doubt true that sometimes complicated questions requiring recording of evidence of experts may arise in a complaint about deficiency in service based on the ground of negligence in rendering medical services by a medical practitioner; but this would not be so in all complaints about deficiency rendering services by a medical practitioner. There may be cases which do not raise such complicated questions and the deficiency in service may be due to obvious faults which can be easily established such as removal of the wrong limb or the performance of an operation on the wrong patient or giving injection of a drug to which the patient is allergic without looking into the out patient card containing the warning or use of wrong gas during the course of an anaesthetic or leaving inside the patient swabs or other items of operating equipment after surgery.
Furthermore, in B. Krishna Rao Vs. Nikhil Super Speciality Hospital 2010 (V) SCC513 at para 40 the Hon ble Apex Court was pleased to hold that it is not necessary to have opinion of the expert in each and every case of medical negligence.
The Hon ble Apex Court was pleased to further hold in Nizam Institute of Medical Sciences Vs. Prashant S. Dhananka and others 2009 (VI) SCC 1 that "in a case of medical negligence, once initial burden has been discharged by the complainant by making of a case of negligence on the part of the hospital or the doctor concerned, the owner then shifts on the hospital or to the attending doctors and it is for the hospital to satisfy the court that there was no lack of care or diligence".
A doctrine or rule of evidence in tort law that permits an inference or presumption that a defendant was negligent in an accident injuring the plaintiff on the basis of circumstantial evidence if the accident was of a kind that does not ordinarily occur in the absence of negligencea plaintiff who establishes the elements of res ipsa loquitur can withstand a motion for summary judgment and reach the jury without direct proof of negligence-- Cox v. May Dept. Store Co., 903 P.2d 1119 (1995).
In Byrne vs Boadle, this maxim was used for the first time where the complainant was injured by a barrel that dropped from the window of the defendant. In the abovementioned case, Pollock, C. B., said "here are many incidents from which no presumption of negligence can arise, but this is not true in every case. It is the duty of persons who keep barrels in a warehouse to take care that they do not roll out and I think that such a case will, beyond all doubt, afford prima facie proof of negligence."
This doctrine intends to help direct the court proceedings to a conclusion, especially if it is established through the implication of this doctrine s rule that the injury caused to the claimant would not have occurred or taken place if the defendant wasn t negligent.This also gives enough cause and evidence to hold the defendant liable for his negligent actions.
The thing speaks for itselfis the gist of the maxim Res Ipsa Loquitur Maxim. What are the essentials of this maxim.
1. The injury caused to the plaintiff shall be a result of an act of negligence.
2. There is a lack of evidence, or the evidence presented before the court is insufficient to establish the possibilities of the fault of the plaintiff or third party.
3. The defendant owes a duty of care towards the plaintiff, which he has breached.
4. There is a significant degree of injury caused to the plaintiff.
Applicability of Doctrine of Res Ipsa Loquitur.
The maxim of res ipsa loquitur came into force to benefit the plaintiff as he can use circumstantial evidence to establish negligence.
Consequently, it shifts the burden of proof on the defendant, logic being, where there is an event of unexplained cause, usually, the one that does not occur without the defendant s negligence in controlling the action which has caused the injury to the claimant or destroyed his goods.
In this scenario, the court shall presume negligence on the part of the defendant in such a case unless it includes an appropriate explanation compatible with his taking reasonable care.
In Achutrao Haribhau Khodwa and Others vs. State of Maharashtra and Others, it was considered that the maxim should not be applied in the case of general incidences of neglect and shall only be reflected when there is a significant degree of injury caused.
Section 106 of the Indian Evidence Act Section 106 of the Act provides that when any fact is especially within the knowledge of any person, the burden of proving that fact is upon him.
Res ipsa loquitur is a Latin phrase that means "the thing speaks for itself." In personal injury law, the concept of res ipsa loquitur (or just "res ipsa" for short) operates as an evidentiary rule that allows plaintiffs to establish a rebuttable presumption of negligence on the part of the defendant through the use of circumstantial evidence.
This means that while plaintiffs typically have to prove that the defendant acted with a negligent state of mind, through res ipsa loquitur, if the plaintiff puts forth certain circumstantial facts, it becomes the defendant s burden to prove he or she was not negligent.
Res Ipsa Loquitur and Evidence Law Accidents happen all the time, and the mere fact that an accident has occurred doesn t necessarily mean that someone s negligence caused it. In order to prove negligence in a personal injury lawsuit, a plaintiff must present evidence to demonstrate that the defendant s negligence resulted in the plaintiff s injury. Sometimes, direct evidence of the defendant s negligence doesn t exist, but plaintiffs can still use circumstantial evidence in order to establish negligence.
Circumstantial evidence consists of facts that point to negligence as a logical conclusion rather than demonstrating it outright. This allows judges and juries to infer negligence based on the totality of the circumstances and the shared knowledge that arises out of human experience. Res ipsa is one type of circumstantial evidence that allows a reasonable fact finder to determine that the defendant s negligence caused an unusual event that subsequently caused injury to the plaintiff.
This doctrine arose out of a case where the plaintiff suffered injuries from a falling barrel of flour while walking by a warehouse. At the trial, the plaintiff s attorney argued that the facts spoke for themselves and demonstrated the warehouse s negligence since no other explanation could account for the cause of the plaintiff s injuries.
As it has developed since then, res ipsa allows judges and juries to apply common sense to a situation in order to determine whether or not the defendant acted negligently.
Since the laws of personal injury and evidence are determined at the state level, the law regarding res ipsa loquitur varies slightly between states. That said, a general consensus has emerged, and most states follow one basic formulation of res ipsa.
Under this model for res ipsa, there are three requirements that the plaintiff must meet before a jury can infer that the defendant s negligence caused the harm in question:
• The event doesn t normally occur unless someone has acted negligently;
• The evidence rules out the possibility that the actions of the plaintiff or a third party caused the injury; and • The type of negligence in question falls with the scope of the defendant s duty to the plaintiff.
As mentioned above, not all accidents occur because of someone else s negligence. Some accidents, on the other hand, almost never occur unless someone has acted negligently.
Going back to the old case of the falling flour-barrel, it s a piece of shared human knowledge that things don t generally fall out of warehouse windows unless someone hasn t taken care to block the window or hasn t ensured that items on the warehouse floor are properly stored. When something does fall out of a warehouse window, the law will assume that it happened because someone was negligent.The second component of a res ipsa case hinges on whether the defendant carries sole responsibility for the injury. If the plaintiff can t prove by a preponderance of the evidence that the defendant s negligence cause the injury, then they will not be able to recover under res ipsa.
States sometimes examine whether the defendant had exclusive control over the specific instrumentality that caused the accident in order to determine if the defendant s negligence caused the injury. For example, if a surgeon leaves a sponge inside the body of a patient, a jury can infer that the surgeon s negligence caused the injury since he had exclusive control over the sponges during the operation.
In addition to the first two elements, the defendant must also owe a duty of care to protect the plaintiff from the type of injury at issue in the suit. If the defendant does not have such a duty, or if the type of injury doesn t fall within the scope of that duty, then there is no liability.
For example, in many states, landowners don t owe trespassers any duty to protect them against certain types of dangers on their property. Thus, even if a trespasser suffers an injury that was caused by the defendant s action or inaction and that wouldn t normally occur in the absence of negligence, res ipsa loquitur won t establish negligence since the landowner never had any responsibility to prevent injury to the trespasser in the first place.
Res ipsa only allows plaintiffs to establish the inference of the defendant s negligence, not to prove the negligence completely. Defendants can still rebut the presumption of negligence that res ipsa creates by refuting one of the elements listed above.
For example, the defendant could prove by a preponderance of the evidence that the injury could occur even if reasonable care took place to prevent it. An earthquake could shake an item loose and it could fall out of the warehouse window, for instance.
A defendant could also demonstrate that the plaintiff s own negligence contributed to the injury. To go back to the flour-barrel example, if the defendant shows that the plaintiff was standing in an area marked as dangerous it could rebut the presumption of negligence created by res ipsa.
Finally, the defendant could establish that he did not owe the plaintiff a duty of care under the law, or that the injury did not fall within the scope of the duty owed. For example, if the law only imposes a limited duty on the defendant not to behave recklessly, then res ipsa will not help the plaintiff by creating an inference of negligence since a negligent action would not violate the duty owed to the plaintiff.
According to the Blacks Law Dictionary the maxim is defined as the doctrine providing that, in some circumstances, the mere fact of accidents occurrence raises an inference of negligence so as to establish a prima facie (at first sight) case. It is a symbol for that rule that the fact of the occurrence of an injury taken with the surrounding circumstances may permit an inference or recipes omission of negligence, or make out a plaintiff s prima facie case and present a question of fact for defendant to meet with and explanation. It is merely a short way of saying that the circumstances attendant on the accident are of such a nature to justify a jury in light of common sense and past experience in inferring that the accident was probably the result of the defendant s negligence, in the absence of explanation or other evidence which the jury believes.
Its use in clinical negligence gained some traction before Bolam and Bolitho. Mahon v Osborne [1939] 1 All ER 535, is an early example of the application of res ipsa loquitur in a case where a surgical swab had been left inside a patient s body.
In Clarke v Worboys (1952) Times, 18 March, CA, a patient noticed burns on her buttock shortly after surgical excision of a breast tumour. The surgery involved cauterisation. The Court of Appeal held that this was a case where res ipsa loquitur applied. The outcome was not one that would ordinarily occur in the absence of negligence, and the surgical team were unable to explain how the injury was caused.
In Cassidy v Ministry of Health [1951] 2 KB 343, Denning LJ succinctly summarised the maxim s application to clinical negligence cases: "I went into hospital to be cured of two stiff fingers. I have come out with four stiff fingers and my hand is useless. That should not happen if due care had been used. Explain it if you can."
Ng Chun Pui Vs Lee Chuen Tat, the first defendant was driving a coach owned by the second defendant westwards in the outer lane of dual carriageway in Hong Kong. Suddenly the course across the central reservation and collided with a public bus travelling in the inner lane of the other carriageway, killing one passenger in the bus and injuring the driver and three others on the bus. The plaintiff could not prove that the defendants were negligent and had caused the accident. They however proceeded on the basis of Res Ipsa Loquitur and shifted the onus on the defendants to prove that they were not negligent. However, they failed to do so. And the judicial committee of the Privy Council held the defendants liable for the plaintiffs injuries. MarkLuney and Ken Opliphant, Tort Law Text And Materials (Oxford University Press, New York, 2000) pp 173-175 In A.S. Mittal &Anr Vs State Of UP &Ors , AIR 1979 SC 1570, the defendants had organised an eye camp at Khurja along with the Lions Club. 88 low risk cataract operations were undertaken during the period of the camp. It was however, disastrous as many of those who had been operated upon lost their eyesight due to post medical treatment. Proceedings against the government initiated for negligence of the doctors. Damages worth Rs.12,500/- were paid as interim belief to each of the aggrieved. The decision was on the basis of Res Ipsa Loquitur as the injury would not ave occurred had the doctors not been negligent in not having followed up with post-operation treatment. Res Ipsa Loquitur can be applied in matters where are the procedures have not been followed and is not just limited to the commission of an act.
We can define Medical negligence as the improper or unskilled treatment of a patient by a medical practitioner. This includes negligence in taking care from a nurse, physician, surgeon, pharmacist, or any other medical practitioner. Medical negligenceleads to Medical malpractices where the victims suffer some sort of injury from the treatment given by a doctor or any other medical practitioner or health care professional.
Medical negligence can occur in different ways. Generally, it occurs when a medical professional deviates from the standard of care that is required.
So, we can say that any kind of deviation from the accepted standards of medication and care is considered to be medical negligence and if it causes injury to a patient then the doctor who operated on him, other staff and/or hospital may be held liable for this.
Some of the common categories of medical negligence are as follows:
• Wrong diagnosis - When someone goes to a hospital, clinic or medical room, etc. the first step after admittance is the diagnosis. Diagnosing symptoms correctly is critical and important to provide medical care to any patient. However, if a patient is not treated properly due to any mistake in diagnosis, the doctor can be made liable for any further injury or damages caused as a result of the wrong diagnosis.
• Delay in diagnosis - A delayed diagnosis is treated as medical negligence if another doctor would have reasonably diagnosed the same condition in a timely fashion. A delay in diagnosis can cause undue injury to the patient if the illness or injury is left to worsen with time rather than being treated. Obviously, any delay in the identification and treatment of an injury can reduce the chance of recovery for the patient.
• Error in surgery - Surgical operations require an enormous level of skill and it should be done with due care and caution because even the slightest mistakes can have profound effects on the patient. The wrong-site surgery, lacerations of any internal organ, severe blood loss, or a foreign object being left in the body of the patients, all this comes under Surgical error.
• Unnecessary surgery - Unnecessary surgery is usually associated with the misdiagnosis of patient symptoms or a medical decision without proper consideration of other options or risks. Alternatively, sometimes surgery is chosen over conventional treatments for their expediency and ease compared to other alternatives.
• Errors in the administration of anesthesia - Anesthesia is a risky part of any major medical operation and requires a specialist (anesthesiologist) to administer and monitor its effect on the patient. Prior to any medical procedure requiring anesthesia, the anesthesiologist has to review the patient s condition, history, medications, etc. to determine the most suitable of all the medicine to use. Anesthesia malpractice can happen even during the pre-operation medical review or during the procedure itself.
• Childbirth and labor malpractice - Childbirth is a difficult event for a woman and it becomes worse if not handled properly by the doctors and nurses. There are many instances of medical negligence during childbirth including the mishandling of a difficult birth, complications with induced labor, misdiagnosis of a newborn medical condition, etc. • Long-Term negligent treatment - Medical negligence can also occur in subtle ways over the course of a long treatment period. Usually, the negligence can take the shape of a failure to follow up with treatment, or a doctor s failure to monitor the effects of the treatment properly.
A standard of care specifies the appropriate treatment and medication procedure as per the requirements that should be taken into account by a doctor while providing the treatment to his patients. The care should not be of the highest degree nor the lowest. Here, the degree means the level of care an ordinary health care professional, with the same training and experience, would render in similar circumstances in the same community. This is the critical question in medical malpractice cases and if the answer is "no," and you suffered injury as a result of the poor treatment, you may file a suit for medical malpractice.
In the case of Dr. Laxman Balkrishna Joshi Vs. Dr. TrimbakBapu Godbole and Anr.[ 1969 AIR 128], the Supreme Court held that a doctor has certain aforesaid duties and a breach of any of those duties can make him liable for medical negligence. A doctor is required to exercise a reasonable degree of care that is set for this profession.
Dr. Kunal Saha vs Dr. Sukumar Mukherjee on 21 October, 2011 ( NC) original petition number 240 OF 1999 is one of the most important case regarding medical negligence. The brief facts of the case are-
Toxic Epidermal Necrolysis ( TEN ) is a rare and deadly disease. It is an extoliative dermatological disorder of unknown cause. A patient with TEN loses epidermis in sheet-like fashion leaving extensive areas or denuded dermis that must be treated like a larze, superficial, partial-thickness burn wound. The incidence of TEN has been reported at 1 to 1.3 per million per year. The female-male ratio is 3:2. TEN accounts for nearly 1% of drug reactions that require hospitalization. TEN has a mortality rate of 25 to 70%.
Smt. Anuradha Saha (in short Anuradha), aged about 36 years wife of Dr. Kunal Saha (complainant) became the unfortunate victim of TEN when she alongwith the complainant was in India for a holiday during April-May 1998. She and the complainant although of Indian original were settled in the United States of America. The complainant is a doctor by profession and was engaged in research on HIV / AIDS for the past fifteen years. Anuradha after acquiring her Graduation and Masters Degree was pursuing a Ph.D. programme in a university of U.S.A. She was a Child Psychologist by profession. Anuradha showed certain symptoms of rashes over her body and received treatment at the hands of Opposite Parties and some other doctors as outdoor patient uptil 10.05.1998 and she was admitted in Advanced Medicare and Research Institute Limited, Calcutta (for short, AMRI), on 11.05.1998, where she was treated by the above-named Opposite Parties and other doctors uptil 16.05.1998. As there was no improvement in her condition, she was shifted to Breach Candy Hospital, Mumbai, on 17.05.1998 by an air ambulance. She was treated in Breach Candy Hospital from 17.05.1998 evening till she breathed her last on 28.05.1998.
Our Complainant as husband of Anuradha felt that the doctors who treated Anuradha and the hospitals where she was treated were grossly negligent in her treatment and her death was occasioned due to gross negligence of the treating doctors and hospitals. Complainant, accordingly, got issued a legal notice to as many as 26 persons i.e. various doctors who treated Anuradha between end of April to the date of her death alleging negligence and deficiency in service on their part and claiming a total compensation exceeding Rs.55 crores from them. Complainant, thereafter filed the present complaint on 09.03.1999 before this Commission claiming a total compensation of Rs. Rs.77,07,45,000/- ( Seventy Seven Crores Seven Lakhs Fourty Five Thousand only). Later he also filed another complaint no. 179 of 2000 in this Commission against Breach Candy Hospital, its doctors and functionaries claiming a further compensation of Rs.25.30 crore ( though the said complaint was later on withdrawn), thereby making claim of compensation exceeding Rs.102 crores, perhaps the highest ever claimed by any complainant for medical negligence before any consumer fora established under the provisions of Consumer Protection Act, 1986 ( in short, the Act). These are some of the facts which make the present case extra ordinary.
The present complaint was filed by the complainant against the above-named opposite parties, namely, Dr. Sukumar Mukherjee, Dr. B. Haldar (Baidyanath Halder), Advanced Medicare and Research Institute Limited ( in short the AMRI Hospital ) and Dr. Balram Prasad and Dr.Abani Roy Chowdhury (physician) and Dr. Kaushik Nandy (plastic surgeon), the Directors of the AMRI Hospital and others claiming a total compensation of Rs. Rs.77,07,45,000/- under different heads alleging various acts of commission and omission on the part of the doctors and hospital amounting to negligence and deficiency in service. Complainant through his brother-in-law Malay Kumar Ganguly also filed criminal complaint against some of the doctors and the hospital under section 304A IPC.
The complaint was resisted by the doctors and the hospital on a variety of grounds thereby denying any medical negligence or deficiency in service on their part. Parties led voluminous documentary and oral evidence and testimonies of some of the witness were even recorded through video conferencing through a Local Commissioner. After a protracted trial and hearing and on consideration of the evidence and material so produced on record and taking note of the legal position governing the question of medical negligence, this Commission ( by a three Member Bench presided over by the then President) dismissed the complaint by an order dated 01.06.2006 holding as under:
In the result, we reiterate that Doctors or Surgeons do not undertake that they will positively cure a patient. There may be occasions beyond the control of the medical practitioner to cure the patients. From the record, it would be difficult to arrive at the conclusion that the injection Depo-Medrol prescribed by Dr. Mukherjee was of such excessive dose that it would amount to deficiency in service by him which was his clinical assessment.
Thereafter, with regard to the alleged deficiency in the treatment given to Mrs. Anuradha by Opposite Party Doctors 2, 3, 5 and 6, there is no substance. The contention against the hospital that it was not having Burns-Ward, and therefore, the deceased suffered is also without substance. Hence, this complaint is dismissed. There shall be no order as to costs.
Aggrieved by the dismissal of his complaint, the complainant filed Civil Appeal (No.1727 of 2007) in the Honble Supreme Court. It would appear that even before the said appeal was filed before the Hon ble Supreme Court, the Supreme Court was seized of the matter in Criminal Appeal Nos.1191-94 of 2005 filed by Malay Kumar Ganguly, the complainant in the criminal complaint, against the Orders passed by the Calcutta High Court. Since the Criminal Appeals and the Civil Appeal filed by the complainant in the present complaint raised the same questions of fact and law, the Hon ble Supreme Court heard all the appeals together and decided the same by means of a detailed judgment dated 07.8.2009. By the said order, the Apex Court dismissed the Criminal Appeals filed by Shri Malay Kumar Ganguly but allowed the Civil Appeal No. 1727 of 2007 filed by the complainant and set aside the order dated 01.6.2006 passed by this Commission dismissing the complaint and remanded the matter to this Commission for the limited purpose of determining the adequate compensation, which the complainant is entitled to receive from the subsisting opposite parties by observing as under:
So far as the judgment of the Commission is concerned, it was clearly wrong in opining that there was no negligence on the part of the Hospital or the doctors. We, are, however, of the opinion, keeping in view the fact that Dr.KaushikNandy has done whatever was possible to be done and his line of treatment meets with the treatment protocol of one of the experts viz.. Prof. Jean Claude Roujeau although there may be otherwise difference of opinion, that he cannot be held to be guilty of negligence.
We remit the case back to the Commission only for the purpose of determination of the quantum of compensation. We, keeping in view the stand taken and conduct of AMRI and Dr. Mukherjee, direct that costs of Rs.5,00,000 and Rs.1,00,000 would be payable by AMRI and Dr. Mukherjee respectively.
We further direct that if any foreign experts are to be examined it shall be done only through video conferencing and at the cost of the respondents.
Summary In view of the foregoing discussion, we conclude as under:
The facts of this case viz., residence of the complainant and Anuradha (deceased) in USA and they working for gain in that country; Anuradha having been a victim of a rare and deadly disease Toxic Epidermal Necrolysis (TEN) when she was in India during April-May 1998 and could not be cured of the said disease despite her treatment at two superspeciality medical centres of Kolkata and Mumbai and the huge claim of compensation exceeding Rs.77 crores made by the complainant for the medical negligence in the treatment of Anuradha makes the present case somewhat extraordinary.
The findings given and observations made by the Supreme Court in its judgment dated 07.08.2009 are absolutely binding on this Commission not only as ratio decidendi but also as obiter dicta also, the judgment having been rendered by the Supreme Court in appeal against the earlier order passed by a three Member Bench of this Commission and, therefore, no attempt can be allowed to read down / dilute the findings and observations made by the Supreme Court because the Supreme Court has remitted the complaint to this Commission only for the purpose of determination of the quantum of compensation after recording the finding of medical negligence against the opposite parties and others.
The task entrusted to the Commission may appear to be simple but the facts of the present case and the voluminous evidence led on behalf of the complainant has made it somewhat arduous. Still difficult was the task of apprortionment of the liability to pay the awarded amount by the different opposite parties and perhaps it was for this reason that the Supreme Court has remitted the matter to this Commission.
Multiplier method provided under the Motor Vehicles Act for calculating the compensation is the only proper and scientific method for determination of compensation even in the cases where death of the patient has been occasioned due to medical negligence / deficiency in service in the treatment of the patient, as there is no difference in legal theory between a patient dying through medical negligence and the victim dying in industrial or motor accident. The award of lumpsum compensation in cases of medical negligence has a great element of arbitrariness and subjectivity.
The foreign residence of the complainant or the patient and the income of the deceased patient in a foreign country are relevant factors but the compensation awarded by Indian Fora cannot be at par which are ordinarily granted by foreign courts in such cases. Socio economic conditions prevalent in this country and that of the opposite parties / defendants are relevant and must be taken into consideration so as to modulate the relief. A complainant cannot be allowed to get undue enrichment by making a fortune out of a misfortune. The theoretical opinion / assessment made by a Foreign Expert as to the future income of a person and situation prevalent in that country cannot form a sound basis for determination of future income of such person and the Commission has to work out the income of the deceased having regard to her last income and future prospects in terms of the criteria laid down by the Supreme Court.
There exists no straight jacket formula for apportionment of the awarded compensation amongst various doctors and hospitals when there are so many actors who are responsible for negligence and the apportionment has to be made by evolving a criteria / formula which is just going by the nature and extent of medical negligence and deficiency in service established on the part of different doctors and hospitals.
On a consideration of the entirety of the facts and circumstances, evidence and material brought on record, we hold that overall compensation on account of pecuniary and non pecuniary damages works out to Rs.1,72,87,500/- in the present case, out of which we must deduct 10% amount on account of the contributory negligence / interference of the complainant in the treatment of Anuradha. That will make the net payable amount of compensation to Rs.1,55,58,750/- (rounded ofto Rs.1,55,60,000/-). From this amount, we must further deduct a sum of Rs.25,93,000/- which was payable by Dr. Abani Roy Chowdhury (deceased) or his Legal Representative as the complainant has forgone the claim against them.
In view of the peculiar facts and circumstances of the case and as a special case, we have awarded a sum of Rs. 5,00,000/- as cost of litigation in the present proceedings.
The above amount shall be paid by opposite parties no.1 to 4 to the complainant in the following manner:
(i) Dr. Sukumar Mukherjee-opposite party no.1 shall pay a sum of Rs.40,40,000/- (Rupees Forty Lakh Forty Thousand only) i.e. [Rs.38,90,000/- towards compensation and Rs.1,50,000/- as cost of litigation].
(ii) Dr. B. Haldar (Baidyanth Halder)-opposite party no.2 shall pay a sum of Rs.26,93,000/- (Rupees Twenty Six Lakh Ninety Three Thousand only) i.e. [Rs.25,93,000/- towards compensation and Rs.1,00,000/- as cost of litigation]
(iii) AMRI hospital-opposite party no.3 shall pay a sum of Rs.40,40,000/- (Rupees Forty Lakh Forty Thousand only) i.e. [Rs.38,90,000/- towards compensation and Rs.1,50,000/- as cost of litigation .
(iv) Dr. Balram Prasad-opposite party no.4 shall pay a sum of Rs.26,93,000/- (Rupees Twenty Six Lakh Ninety Three Thousand only) i.e. [Rs.25,93,000/- towards compensation and Rs.1,00,000/- as cost of litigation] The opposite parties are directed to pay the aforesaid amounts to the complainant within a period of eight weeks from the date of this order, failing which the amount shall carry interest @ 12% p.a. w.e.f. the date of default."
Now in the present case it has become clear that the opposite party did not take the proper step. The consent taken is defective. They did not get the copy of ultrasound report from the patient and now they say it was the negligence of the patient and not of the doctor. They did not give the patient post-operative care. The knew that in such procedure, there may be bile duct leakage but they did not perform any test for the confirmation of bile duct leakage. They simply refer the patient to some other hospital which shows that they lack necessary equipments for emergency. They did not tell the patient all the pros and cons of the laparoscopic cholecystectomy. No doctor has put his signature on the consent form. All these show the negligence on the part of the opposite parties. After considering all the facts and circumstances of the appellant case and also after perusing the judgement of the only Supreme Court and Hon ble NCDRC we come to the conclusion that the complainant is entitled for the following reliefs from the opposite parties.
The complainant is entitled to get Rs.20 lakhs from the opposite parties jointly and severally with interest at a rate of 12% from 06.07.2017 if paid within 60 days from the date of judgement of this complaint case otherwise the rate of interest shall be 15% from 06.07.2017 till the date of actual payment.
The complainant is entitled to get Rs.10 lakhs from the opposite parties, jointly and severally for the expenses in various diagnostic centres and medicines including the major surgery at Jaypee hospitalwith interest at a rate of 12% from 06.07.2017 if paid within 60 days from the date of judgement of this complaint case otherwise the rate of interest shall be 15% from 06.07.2017 till the date of actual payment.
The complainant is entitled to get Rs.20 lakhs from the opposite parties, jointly and severally for mental torture, harassment, depression, agony etc with interest at a rate of 12% from 06.07.2017 if paid within 60 days from the date of judgment of this complaint case otherwise the rate of interest shall be 15% from 06.07.2017 till the date of actual payment.
The complaint case is decided accordingly.
ORDER The complaint is allowed with cost. The opposite parties no.1 & 2 jointly and severally are directed to pay to the complainant Rs.20 lakhs with interest at a rate of 12% from 06.07.2017 if paid within 60 days from the date of judgement of this complaint case otherwise the rate of interest shall be 15% from 06.07.2017 till the date of actual payment.
The opposite parties no.1 & 2 jointly and severally are directed to pay to the complainant Rs.10 lakhs for the expenses in various diagnostic centres and medicines including the major surgery at Jaypee hospitalwith interest at a rate of 12% from 06.07.2017 if paid within 60 days from the date of judgement of this complaint case otherwise the rate of interest shall be 15% from 06.07.2017 till the date of actual payment.
The opposite parties no.1 & 2 jointly and severally are directed to pay to the complainant Rs.20 lakhs from the opposite parties, jointly and severally for mental torture, harassment, depression, agony etc with interest at a rate of 12% from 06.07.2017 if paid within 60 days from the date of judgment of this complaint case otherwise the rate of interest shall be 15% from 06.07.2017 till the date of actual payment.
If the said amount has not been paid within 60 days from the date of judgment of this complaint case, the complainant shall be free to file execution case at the cost of the opposite parties.
The stenographer is requested to upload this order on the Website of this Commission today itself.
Certified copy of this judgment be provided to the parties as per rules.
(Sushil Kumar) (Rajendra Singh) Member Presiding Member Judgment dated/typed signed by us and pronounced in the open court. Consign to record. (Sushil Kumar) (Rajendra Singh) Member Presiding Member Dated 31.5.2023 JafRi, PA I Court 2 (सुरक्षित) राज्य उपभोक्ता विवाद प्रतितोष आयोग , उ0प्र0, लखनऊ परिवाद संख्या-392/2018 श्रीमती अनीता भाटी बनाम गार्गी हॉस्पिटल तथा अन्य माननीय सदस्य , श्री सुशील कुमार द्वारा दिया गया भिन्न निष्कर्ष 31 .05.2023 :-
1. प्रस्तुत परिवाद संख्या-392/2018, श्रीमती अनीता भाटी बनाम गार्गी हॉस्पिटल तथा अन्य में माननीय सदस्य, श्री राजेन्द्र सिंह द्वारा दिए गए निर्णय से मैं (सुशील कुमार) सहमत नहीं हूँ, इसलिए इस निष्कर्ष के विपरीत (पृष्ठ संख्या-208 के आगे) मेरे द्वारा निम्नलिखित निष्कर्ष/आदेश दिया जा रहा है :-
2. परिवादिनी द्वारा इलाज के खर्च में कुल 20 लाख रूपये की मांग की गई है, जिसमें से अंकन 16 लाख रूपये वह भी शामिल हैं, जो जेपी हॉस्पिटल में मेजर सर्जरी में खर्च किए गए हैं। परिवादिनी द्वारा इलाज से संबंधित खर्च की जो रसीदें प्रस्तुत की गई हैं, उनके अवलोकन से जाहिर होता है कि शपथ पत्र के साथ पृष्ठ संख्या-14 में जो रसीद संलग्न की गई है, उसमें अंकन 4,500/-रू0 अंकित है। इसी प्रकार जो रसीद पूर्व में प्रस्तुत की गई है, जिनको शपथ पत्र के साथ दोहराया गया है, उनमें दस्तावेज संख्या-25 पर अंकन 12,860/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-26 पर अंकन 13067/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-27 पर अंकन 250/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-28 पर अंकन 1,540/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-29 पर अंकन 5,500/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-30 पर अंकन 400/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-31 पर अंकन 399/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-32 पर अंकन 586/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-33 पर रू0 71.52 पैसे की रसीद संलग्न है, दस्तावेज संख्या-34 पर अंकन 389/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-35 पर अंकन 616/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-36 पर अंकन 600/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-37 पर अंकन 600/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-38 पर अंकन 400/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-39 पर अंकन 350/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-40 पर अंकन 400/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-41 पर अंकन 1,540/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-42 पर अंकन 700/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-43 पर अंकन 700/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-44 पर अंकन 700/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-45 पर अंकन 12,705/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-46 पर अंकन 2,594/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-47 पर अंकन 744/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-48 पर अंकन 600/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-49 पर अंकन 62/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-50 पर अंकन 537/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-51 पर अंकन 993/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-52 पर अंकन 600/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-53 पर अंकन 1,540/-रू0 की रसीद संलग्न है, दस्तावेज संख्या-54 लगात 61 पर अंकन 2,20,000/-रू0 की रसीद संलग्न हैं तथा दस्तावेज संख्या-62 लगात 71 पर अंकन 3,37,424/-रू0 की रसीद संलग्न है। इन कुल रसीदों का योग रू0 6,23,467.52 पैसे होता है। अत: परिवादिनी इस मद में केवल रू0 6,23,467.52 पैसे प्राप्त करने के लिए अधिकृत है। परिवादिनी द्वारा इस राशि पर 18 प्रतिशत की दर से ब्याज दिलाए जाने की प्रार्थना की गई है, परन्तु चूंकि इस आयोग द्वारा अधिकांश मामलों में 09 प्रतिशत की दर से ब्याज अदा करने का आदेश पारित किया गया है। अत: इस राशि पर परिवाद प्रस्तुत करने की तिथि से वास्तविक अदायगी की तिथि तक ब्याज 09 प्रतिशत प्रतिवर्ष की दर से देय होगा।
3. परिवादिनी द्वारा अनुतोष के क्रमांक तृतीय में मानसिक प्रताड़ना की मद में अंकन 50 लाख रूपये की मांग की गई है। प्रस्तुत केस की समस्त विवेचना के पश्चात यह निष्कर्ष निकलता है कि विपक्षी हॉस्पिटल/डॉ0 द्वारा उचित रूप से सहमति प्राप्त नहीं की गई। मरीज से अल्ट्रासाउण्ड रिपोर्ट प्राप्त नहीं की गई तथा आपरेशन के पश्चात समुचित देखभाल नहीं की गई, जिसके कारण Bile Duct Leecage संभव हो सकती है और उनके द्वारा इस संभावना को दृष्टिगत रखते हुए कोई परीक्षण नहीं कराया गया और मरीज को दूसरे हॉस्पिटल में रेफर कर दिया गया। अत: इस समुचित लापरवाहीपूर्ण कृत्य के लिए मानसिक प्रताड़ना की मद में केवल 05 लाख रूपये की क्षतिपूर्ति का आदेश देना उचित है। तदनुसार प्रस्तुत परिवाद आंशिक रूप से स्वीकार होने योग्य है।
आदेश
4.(क). प्रस्तुत परिवाद आंशिक रूप से स्वीकार किया जाता है। विपक्षीगण को एकल एवं संयुक्त दायित्व के तहत आदेशित किया जाता है कि परिवादिनी को रू0 6,23,467.52 पैसे (छ: लाख तेईस हजार चार सौ सढ़सठ रूपये बावस पैसे) की राशि परिवाद प्रस्तुत करने की तिथि से वास्तविक भुगतान की तिथि तक मय 09 प्रतिशत प्रतिवर्ष ब्याज के साथ 03 माह की अवधि के अंदर अदा करें। यदि 03 माह की अवधि के अंदर यह राशि अदा नहीं की जाती है तब इस राशि पर 12 प्रतिशत प्रतिवर्ष की दर से ब्याज देय होगा।
(ख) विपक्षीगण को एकल एवं संयुक्त दायित्व के तहत आदेशित किया जाता है कि परिवादिनी को मानसिक प्रताड़ना की मद में अंकन 5,00,000/-रू0 (पांच लाख रूपये) की राशि 03 माह की अवधि के अंदर अदा करें। यदि 03 माह की अवधि के अंदर यह राशि अदा कर दी जाती है तब इस राशि पर कोई ब्याज देय नहीं होगा और यदि 03 माह के अंदर यह राशि अदा नहीं की जाती है तब इस राशि पर परिवाद प्रस्तुत करने की तिथि से वास्तविक भुगतान की तिथि तक 12 प्रतिशत प्रतिवर्ष की दर से ब्याज देय होगा।
(ग) विपक्षीगण को एकल एवं संयुक्त दायित्व के तहत आदेशित किया जाता है कि परिवादिनी को परिवाद व्यय के रूप में अंकन 25,000/-रू0 (पच्चीस हजार रूपये) 03 माह की अवधि के अंदर अदा करें। यदि 03 माह की अवधि के अंदर यह राशि अदा कर दी जाती है तब इस राशि पर कोई ब्याज देय नहीं होगा और यदि 03 माह के अंदर यह राशि अदा नहीं की जाती है तब इस राशि पर परिवाद प्रस्तुत करने की तिथि से वास्तविक भुगतान की तिथि तक 12 प्रतिशत प्रतिवर्ष की दर से ब्याज देय होगा।
आशुलिपिक से अपेक्षा की जाती है कि वह इस आदेश को आयोग की वेबसाइट पर नियमानुसार यथाशीघ्र अपलोड कर दे।
(सुशील कुमार) सदस्य लक्ष्मन, आशु0, कोर्ट-2 C/392/2018 Smt. Anita Bhati V/s Gargi Hospial and another 12-07-2023 The case is called out.
As prayed by learned Counsel for the parties list on 24-07-2023.
( Justice Ashok Kumar ) President Pnt Court-1 STATE CONSUMER DISPUTES REDRESSAL COMMISSION, UTTAR PRADESH, LUCKNOW C/392/2018 Smt. Anita Bhati V/s Gargi Hospital and another BY MR. JUSTICE ASHOK KUMAR, PRESIDENT ORDER The instant complaint has been heard by Division Bench of Sri Rajendra Singh, Presiding Member and Sri Sushil Kumar, Member. The judgment has been delivered by the aforesaid bench on 31-05-2023. Though the learned Members are agreed with regard to the deficiency of the opposite party/the hospital/Doctor, however, there is difference of opinion between the learned Members with regard to the payment of cost of damages and payment of cost under the heading permanent disability and cost of the case.
I have heard Sri Rishi Raj Singh alongwith Sri Hemraj Mishra, learned Counsel for the complainant and on behalf of opposite parties No. 01 and 02 Sri Adeel Ahmad and for opposite party No.03 Sri Zafar Aziz.
The name of the complainant is Smt. Anita Bhati.
After hearing the learned Counsel for the respective parties and after perusing the entire record as well as after analysing the judgments of learned Members very carefully, I am in agreement with the opinion of both the learned Members with regard to deficiency in service committed by the opposite party and in allowing the complaint but I am disagreeing with the view of learned Presiding Member Sri Rajendra Singh with regard to the compensation, cost and interest etc. awarded by him in his judgment.
In my considered opinion, the compensation, cost and interest etc. awarded by learned Presiding Member are too much on the higher side.
As regards the compensation, cost and interest awarded by learned Member Sri Sushil Kumar in his judgment, I am in fully agreement with his view and the judgment of learned Member Sri Sushil Kumar is fully justified and it should be upheld.
On the basis of the above analysis, I do hereby concur with the :2: judgment pronounced by learned Member Mr Sushil Kumar and in view of the above, I am in agreement with the opinion of Sri Sushil Kumar, Member.
The judgment of mine and of Sri Sushil Kumar, Member will prevail majority judgment.
Let copy of this order is made available to the parties as per rules.
The Stenographer is requested to upload this order on the website of this Commission at the earliest.
(JUSTICE ASHOK KUMAR ) PRESIDENT Pnt.
[HON'ABLE MR. JUSTICE PRESIDENT] PRESIDENT [HON'BLE MR. Rajendra Singh] JUDICIAL MEMBER [HON'BLE MR. SUSHIL KUMAR] JUDICIAL MEMBER