NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION
FIRST APPEAL No. 248 OF 2002
Rajinder Singh Dogra
3152, Sector 28 D Appellant
Dr. P.N. Gupta
P. N. Urology and Surgical Centre
House no. 1359, Sector 40 B Respondent
HON’BLE MR. JUSTICE R. C. JAIN PRESIDING MEMBER
HON’BLE MR. ANUPAM DASGUPTA MEMBER
For the Appellant Mr. Ravi Kant Sharma, Advocate
For the Respondent Mr. Sagar Saxena, Advocate with
Mr. S. K. Rai, Advocate
Pronounced on 16th July 2012
This appeal against the order dated 27.03.2002 of the Consumer Disputes Redressal Commission, Union Territory, Chandigarh (in short, ‘the State Commission’) in complaint case no. 6 of 2001 has been filed by the complainant (Rajinder Singh Dogra). By this order, the State Commission dismissed the complaint holding that the complainant had failed to prove his allegations of medical negligence, carelessness and deficiency in service on the part of the opposite party (OP -Dr P.N. Gupta) in the treatment of his wife (Smt. Reeta Dogra). For the sake of convenience, the parties are referred to as per their status before the State Commission.
2. The undisputed facts are that the complainant’s wife (Reeta) suffered from abdominal pain for some time. On ultrasonography of the abdomen, she was diagnosed with stones in her gallbladder. The complainant and his wife approached the OP at his P.N. Urology and Surgical Centre (hereafter, ‘Centre’) for consultation on this problem. The OP advised surgery and fixed it for 11.09.2000. Some necessary preliminary tests were also advised. The surgery was conducted on 11.09.2000 as scheduled and the patient was discharged the very next day, i.e., on 12.09.2000 with the advice of follow-up visit to the Centre on 20.09.2000 for removal of stitches (and the drain). The stitches (and the drain) were removed on that date. Thereafter, the patient went to the Centre for consultation with the OP on 25.09.2000, 28.09.2000 and 30.09.2000 with complaints of stomach ache, constipation and vomiting (the last being complained of on 30.09.2000). She was treated symptomatically by prescribing a mild laxative (Isabgol) and an antacid (Ocid). On 02.10.2000 she was again taken to the OP with complaints of serious discomfort and yellow pigmentation of her eyes. The OP then advised ultrasonography and x-ray investigations. After seeing the reports of these tests, the OP admitted her to the Centre on the same day (02.10.2000). On 03.10.2000, the OP drained out about 100 cc of bile-stained fluid from the patient’s peritoneal cavity. On 04.10.2000, he conducted another surgery (laparotomy) and placed a tube drain to remove the ascitic (abdominal) fluid. This was followed by ultrasonography and chest x-ray on 10.10.2000. On 12.10.2000, the patient was referred to one Dr. Neeraj Nagpal for Endoscopic Retrograde Cholangio Pancreatography (ERCP) to evaluate the biliary system for leak, residual stones, etc. ERCP could not be conducted fully because of difficulty in cannulating the bile duct and the patient was referred back to the OP. On 13.10.2000, the OP referred the patient to the Department of Hepatology (Liver Clinic) at the Post Graduate Institute of Medical Education and Research (PGI), Chandigarh for further investigations and treatment. A repeat ERCP was done on 16.10.2000 at the PGI which showed a deformed anatomy at D1/ D2, minimal narrowing of the Central Bile Duct (CBD) and a leak in the area of the Cystic Duct. Sphincterotomy of about 7 mm was done and a 7 cm stent was put in place. Post-ERCP, the patient remained well for about 24 hours whereafter she started developing ERCP-induced pancreatitis. Despite intensive treatment at the PGI, she went on to develop sepsis and multi organ failure from which she could not recover and ultimately expired on 04.11.2000.
3. The main allegation in the complaint was that though Reeta continued to complain of pain ever since 12.09.2000 and visited the OP on 20.03.2000, 25.09.2000 and 28.09.2000 with the same complaint of persisting stomach pain, the OP did nothing more than prescribing Liquid Cremaffin and Isabgol and, on 30.09.2000, despite her complaint of vomiting, he only prescribed Ocid (an antacid). Thus, during this entire period, the OP made no attempt to advise appropriate investigations to ascertain the cause of persisting stomach pain. As a result of this prolonged neglect of her post-surgery complaints, Reeta developed obstructive jaundice and further complications. Though the OP carried out fluid aspiration on 03.10.2000 and another surgery (laparotomy) on 04.10.2000 to place a drain, he failed to make out the cause and location of bile leakage. ERCP, belatedly recommended and attempted on 12.10.2000 (at a private clinic instead of a tertiary medical care centre) was also unsuccessful. It was only thereafter that the OP thought it fit to refer Reeta to the PGI. The complainant also alleged that the OP knew from the x-ray taken on 03.10.2000 that the patient had developed lung complications but he did nothing about it. According to the complainant, it was the negligence on the part of the OP in not being able to ascertain the location of bile leakage and persisting with his line of treatment from 04.10.2000 in particular that Reeta developed various intractable complications by the time she was referred to the PGI on 13.10.2000.
4. The OP denied all the material allegations and cited a variety of medical literature in support of his contention that he had followed the standard medical protocol in carrying out the gallbladder surgery and post-operative care.
5. Before the State Commission, both the complainant and the OP were examined and cross-examined and, in addition, one Dr. Shibumon, Senior Resident (SR) in the Department of Surgery, PGI was also examined on behalf of the complainant and cross-examined by the counsel for the OP.
6. On consideration of the pleadings, evidence, documents and medical literature brought on record by the parties, the State Commission came to several findings: in particular, the State Commission observed as under:
“The aforesaid statement of the complainant will clearly go to show that he had gone to Dr. P.N. Gupta, the OP as he was satisfied about his competence in treating his wife, though earlier on he had gone to Chandigarh Medical College Hospital, Sector 32 but did not get his wife admitted for treatment there. This statement coupled with his admission that Dr. P.N. Gupta rendered all help and provided necessary relief whenever he approached him regarding the treatment of his wife and the further fact that Dr. P.N. Gupta did not charge any fee regarding the second operation clearly go to negative the allegation made by the complainant about negligence and carelessness on the part of the OP in the treatment of his wife, Smt. Reeta Dogra. It may be pointed out that in the complaint itself, the complainant has alleged in paragraph 4 that he made efforts for resolving the dispute with the OP. The OP offered a sum of Rs.25,000/- to him which he did not accept and thereafter he sent notice and filed the complaint.
The OP Dr. P.N. Gupta had advised for ERCP test to be conducted on the patient, Smt Reeta Dogra for which she was taken to Dr. Neeraj Nagpal, who, as stated above, could not successfully conduct the ERCP test. Thereafter, Dr. P.N. Gupta referred the patient to Prof. Virender Singh of the Department of Hepatology (Liver Clinic), PGIMER, Chandigarh where she was admitted on 13.10.2000. The ERCP test was conducted at PGI and thereafter the complication of pancreatitis was detected. The patient developed other complications at PGI and she eventually died at PGI on 04.11.2000. The cause of death as mentioned above was the acute pancreatitis described in medical terms as ‘Grade F Post ERCP Pancreatitis with B/L plural effusion with ARF with Sepsis with ARDS’.
The cause of death has not been connected in any manner with the surgery performed at the clinic of Dr. P.N. Gupta/OP. In any case, the complainant has not been able to show that Dr. P.N. Gupta/OP did not follow the well-established medical principles relating to the surgery in treatment for the removal of the gallbladder or for the treatment of the biliary leakage at his clinic. Dr. P.N. Gupta on the other hand claimed that he performed thousands of such operations successfully and maintained his statement that he followed the standard medical practice regarding the performance of surgery for removal of gallbladder even in the second surgery”.
7. Relying on some decisions of the Supreme Court and the National Commission, the State Commission concluded that the complainant had failed to prove his allegations of medical negligence on the part of the OP.
8. We have heard Mr. Ravi Kant Sharma, learned counsel for the appellant/complainant and Mr. Sagar Saxena, learned counsel for the respondent/opposite party and carefully considered the documents on record.
9. In the course of hearing, it was suggested by the respondent/OP that opinion of an independent medical expert may be obtained if there was any medical negligence on his part in treating Reeta. Accordingly, by its direction of 29.07.2009 this Commission made a reference to the Director, G. B. Pant Hospital, NewDelhi to constitute a Board of Doctors by observing as under:
“After arguing the matter at length, a suggestion is made from the side of the respondent that to arrive at a just and scientific finding whether there was indeed any medical negligence or deficiency in service in the treatment of Smt. Reeta Dogra, opinion of any expert may be obtained. Appellant and his counsel have no objection to such a course being adopted. Having regard to the facts and circumstances of the case and with the consent of the parties, we consider it expedient in the interest of justice to refer the case for expert opinion of a medical board in the relevant discipline(s).
Let a request be sent to the Director, G. B. Pant Hospital, New Delhi to constitute a Board of not less than three senior Doctors of the relevant discipline(s) who may examine the entire medical record of the patient Smt. Reeta Dogra and the treatment given to her by Dr. P.N. Gupta and also later at the PGIMER, Chandigarh. The Registry may send a request along with copy of the entire medical record to the Director, G. B. Pant Hospital for constitution of the Board and to submit a report of the Board on the following points, amongst others:
(i) Whether there was any medical negligence in the surgery of cholecystectomy performed by Dr. P.N. Gupta on the patient on 11.09.2000?
(ii) Whether there was a possibility of occurrence of post-operative biliary leakage and if so, what were the investigative methods available to the doctor to ascertain the incidence of leakage?
(iii) Whether the patient having undergone cholecystectomy on 11.09.2000 could have developed severe biliary leakage (leading to Biliary Peritonitis) suddenly on one date, viz., 30.09.2000?
(iv) Whether the management and surgical intervention by Dr. P.N. Gupta on 30.09.2000 and 03.10.2000 and upto his referral of the patient to the PGIMER on 13.10.2000 was according to the standard medical protocol?
(v) Whether there was any delay and/or any deficiency in providing medical service in that behalf, particularly in respect of the points at (ii) and (iv)?
(vi) Any other comments the Board may like to give regarding the treatment given to Smt. Reeta Dogra
The Board may be advised to give their reasons for their opinion.”
10. In response, the report of a Medical Board was received from the Medical Superintendent of the said Hospital. Each query of this Commission and the corresponding opinion of the Medical Board are reproduced in the Table below:
“The Redressal Commission has sought clarification on the following points. The point by point response to the questions raised are (sic – is) as follows:
|Sr. No.||Query||Opinion of Medical Board|
|(i)||Whether there was any medical negligence in the surgery of cholecystectomy performed by Dr. P.N. Gupta on the patient on 11.09.2000?||Bile duct injury is a well-known complication in patients undergoing Laparoscopic cholecystectomy and occurs in approximately 0.5% of cases. This cannot be termed as medical negligence as some patients may have an unsuitable anatomy as a consequence of past episodes of cholecystitis.|
|(ii)||Whether there was a possibility of occurrence of post-operative biliary leakage and, if so, what were the investigative methods available to the doctor to ascertain the incidence of leakage?||This point is covered vide supra. Bile duct injury results in biliary peritonitis or biloma formation; the standard investigation to detect this is by doing an USG/CT examination.|
|(iii)||Whether the patient having undergone cholecystectomy on 11.09.2000 could have developed severe biliary leakage (leading to Biliary Peritonitis) suddenly on one date, viz., 30.09.2000?||Biliary ascites is usually not an acute event. Gradually over a period of time the fluid goes on accumulating. When this reaches a significant level the patient becomes aware of abdominal distension or pain.|
|(iv)||Whether the management and surgical intervention by Dr. P.N. Gupta on 30.09.2000 and 03.10.2000 and upto his referral of the patient to the PGIMER on 13.10.2000 was according to the standard medical protocol?||The management of post-operative bile leak between 30.09.2000 to 03.10.2000 was as per standard protocol as he inserted a tube drain and then referred the patient for ERCP examination to Dr. N. Nagpal.|
|(v)||Whether there was any delay and/or any deficiency in providing medical service in that behalf, particularly in respect of the points at (ii) and (iv)?||In retrospect some of the investigations if done earlier could have detected the injury/bile collection; however, from the notes it appears that on clinical examination of the patient at the time, Dr. Gupta in his wisdom did not feel that further investigations were warranted and, therefore, prescribed medication for symptomatic relief. This would be medically acceptable. In hindsight this may be construed as an error of judgment on the part of the clinician but cannot be equated with medical negligence.|
11. After copies of the report were made available to the learned counsel for the parties, learned counsel for the appellant made several written submissions, objecting to some findings/interpretations of the Medical Board. These are summarised below:
“Points no. 1 & 2 – The clarification given by the expert opinion shows that (sic) in spite of the fact that there could be biliary leakage that has to be detected by USG/CT examination. But in the present case no USG was done till 02.10.2000 particularly when the patient was in acute pain even on 20.09.2000 when stitches were removed. The doctor failed to diagnose even the known complication when the patient repeatedly visited the clinic of OP on 27.09.2000 and 28.09.2000 also. Therefore, the medical negligence was apparent on the part of the OP.
Point no. 3 – As per the opinion biliary ascites is usually not an acute event. Gradually over a period of time the fluid goes on accumulating. When this reaches a significant level the patient becomes aware of pain. In the present case, the patient had all along been complaining of pain but the OP failed to pick up the leakage; rather continued to prescribe pain killers and ‘Isabgol” instead of standard investigations. Therefore, the OP cannot be absolved of medical negligence.
Point no. 4 – As per the opinion the management of post-operative bile leak between 30.09.2000 to 03.10.2000 was as per standard protocol as he inserted a tube drain and then referred the patient for ERCP examination. In the present case, no post-operative care was done (sic – taken) by the OP from 12.09.2000 to 30.09.2000 as is evident from the history of the case. In spite of the fact that the patient was complaining of acute pain no diagnostic steps were taken to find out the biliary leak as ‘Cholecystectomy’ was done on 11.09.2000 by the OP. Had the doctor given the proper post-operative care in picking up the reasons for pain at an early date, the patient would have survived. This further goes to show that there was deficiency in providing post-operative care by the OP. In spite of the fact that the patient was having bilirubin 9.0 mg, after second operation it has come down to 7.5 mg. As a matter of fact no operation should have been done as the condition of the patient was already deteriorated. Instead of managing Jaundice the OP has straight away jumped to operate a second time and that too without referring the patient for ERCP, inserted tube drain and referred the patient for ERCP on 12.10.2000, i.e., after 8 days when the ERCP was to be done before the second operation. All this goes to show that there was a clear case of medical negligence on the part of the OP.
Point no. 5 – As per the expert opinion, some of the investigations if done earlier could have detected the injury on Common Bile Duct/bile collection as is clear from the notes on the file. It appears that the OP did not feel that further investigations were required therefore prescribed medication for symptomatic relief. It has also been opined that this may be an error of judgment on the part of physician/clinician. But in the present case as the facts speak in itself that if the OP had done the investigations earlier he could have detected the injury to the bile duct and treated the patient in the right protocol immediately after the first surgery. Thus by not doing so the doctor has compromised with the condition of patient thus a clear case of medical negligence. Even the opinion of the G.B. Pant Hospital has come to the conclusion that there was an error of judgment on the part of the doctor – OP treating the patient at that time”.
12. In his response, learned counsel for the respondent/OP submitted as under:
“The expert opinion of the medical board has clearly and specifically held that the respondent cannot be held liable for medical negligence as the treatment given by the respondent was as per set medical standards.
After the receipt of the expert opinion, the appellant has filed written arguments trying to dispute even the expert opinion. As per the directions of this Hon’ble Commission and with a view to bring out correct facts, the respondent is filing its written arguments. Present appeal deserves to be dismissed qua the respondent in view of the below mentioned important facts and circumstances:
(i) It is absolutely wrong that patient was in acute pain even on 20.09.2000. She came on 20.09.2000 for the removal of stitches. No patient can remain in acute pain at home without hospitalisation. Patient came on 28.09.2000 and was attended properly and standard care was given. As per expert opinion by the medical board Bile duct injury is a well-known complication. It cannot be termed as medical negligence.
(ii) When patient did not get relief after 28.09.2000 she was admitted on 30.09.2000 and due care was taken and got investigated and biliary leak was diagnosed by standard investigation by doing ultra sound.
(iii) As per medical opinion biliary ascites means collection of bile in peritoneal cavity. Normal daily bile produced by liver is around 1000-1200 ml per day, if it would have been for very long duration then there is big distension of abdomen which would be quite obvious to the patient and as per record patient never complained that she had distension of abdomen which became easily aware to the patient.
(iv) As per expert medical opinion the management of post-operative bile leak is drainage of bile and ERCP. In this patient exactly in the same way a standard protocol has been followed.
Allegation that ERCP should be done first is absolutely baseless statement written by appellant.
The treatment of bile leak is drainage of bile by putting tube to drain the collected bile and subsequent ERCP has to be done. ERCP is always a procedure done by Gastroenterologist and not by Surgeon.
(v) The line of management did not change it was the same which respondent started initially means when ERCP was failed by Dr. Nagpal. She was referred to PGI for ERCP. Patient remained stable as far as her blood pressure, pulse, her diabetic status and her blood counts are concerned,that means there was no infection till the date 13.10.2000. Therefore even at the time of referral she was admitted in OPD in PGI. It clearly shows that she was in stable condition and the same is the opinion by the expert committee of G. B. Pant Hospital.
In medical science any clinician (doctor who is treating or operating patient) may not diagnose in time does not necessarily mean that he was neglected (sic negligent) or due care has not been given to the patient.”
13(i) Before proceeding further, we may notice that both parties have submitted copies of medical literature to bolster their respective contentions.
(ii) While learned counsel for the appellant/complainant has cited Sleisenger and Fordtran’s Gastrointestinal and Liver Disease, Editors Mark Feldman, Lawrence S. Friedman and Marvin H. Sleisenger, 7th Edition – Section titled, Complications Following Laparoscopic Cholecystectomy, learned counsel for the respondent/OP has referred to a number of Textbooks and Journal Articles, viz., Bailey & Love’s Short Practice of Surgery (21st & 22nd Editions), British Journal of Surgery, 1999 and 1989 (Vol. 76), an Article on Tropical Gastroenterology (Vol. 15, No. 1, 1994) and Maingot’s Abdominal Operations (8th Edition, Vol. 1 and 10th Edition, Vol.2)
(iii) Sleisenger’s Textbook has the following:
“COMPLICATIONS FOLLOWING LAPAROSCOPIC CHOLECYSTECTOMY
Laparoscopic cholecystectomy has largely replaced “open” surgical cholecystectomy because laparoscopic cholecystectomy results in shorter hospital stay, faster recovery and lower overall morbidity rate. Unfortunately the frequency of complications resulting from the bile duct injury has increased with the advent of laparoscopic cholecystectomy. Bile duct injury, which was observed in 0.1% of open cases, may occur in as many as 0.2% to 0.5% of laparoscopic cases. In addition, laparoscopic bile duct injuries tend to be more severe and more difficult to treat than biliary injuries produced by open surgery.
Bile duct injury that occurs during laparoscopic cholecystectomy results in two basic problems: (1) bile leak with biloma formation and (2) biliary obstruction caused by stricture formation. Patients may present with pain and fever from a biloma or jaundice because of biliary obstruction. Bile leaks result from incomplete clipping of the cystic duct or laceration or transection of central or peripheral bile ducts. Failure to recognize variant bile duct anatomy, particularly an aberrant low insertion of a segmental right duct, is a common cause of bile duct transection. Strictures tend to occur in the common hepatic duct owing to thermal injury to the hilum from cautery and dissection probes. Strictures or obstruction can also result from inadvertent ligation of aberrant ducts.
The initial work-up of patients with presumed bile duct injury includes cholangiography to assess the biliary anatomy and a cross-sectional imaging study such as CT or US to investigate the presence and location of biloma. Cholangiography is performed via an endoscopic approach when possible. Biliary tract disruption results in decompression of the bile ducts and the ducts may actually be decreased in calibre, making percutaneous cannulation difficult or even hazardous. When endoscopic cannulation of the duct is not possible or when contrast material cannot be directed into the intrahepatic ducts, PTC may be necessary. In patients with possible laparoscopic cholecystectomy injury, it is particularly important to opacify all the intrahepatic ducts by cholangiography. Inadvertent ligation of peripheral ducts may result in incomplete opacification of the biliary tree, which is difficult to notice immediately.
The treatment of bile duct injury following laparoscopic cholecystectomy depends on the nature and extent of injury. Small to moderate bile duct leaks at the cystic duct stump or peripheral ducts may be cured with nonoperative therapy alone, but large leaks or transection of the main ducts often requires surgery. The treatment of small bile duct leaks includes percutaneous drainage of large or symptomatic bilomas coupled with a biliary drainage procedure to divert bile from the site of injury. The drainage catheter is initially placed into the biloma under US or CT guidance and then the collection is evacuated. External biloma drainage is continued until biliary output through the drain ceases. Biliary diversion is usually achieved endoscopically by sphincterotomy and placement of a temporary plastic endoprosthesis. Although the leak may require several stent changes to achieve complete closure, most leaks will close within six weeks.
Strictures after laparoscopic cholecystectomy may occur after an uneventful operation and may not be recognised until many months to several years after surgery. The treatment of these strictures is usually surgical – creation of a Roux-en Y hepaticojejunostomy. In selected patients who cannot undergo this surgery because of severe medical problems or cirrhosis with portal hypertension, non-operative management by means of balloon dilation and placement of a metallic endoprosthesis may be appropriate. Lillemoe and colleagues reported a success rate of 100% in the treatment of the bile duct strictures using a combination of surgery and percutaneous dilation. However, the cost of treating these patients was quite high, with mean cost of $51,000.
(iv) On the other hand, learned counsel for the respondent/OP has cited several pages of material from various sources without specifying which portions of these texts are relevant to his contentions and how. We have had, therefore, to exercise our judgment/discretion after reading these texts thoroughly to ascertain the relevant parts, which we proceed to extract below (in each case, emphasis supplied]:
(a) “Bailey & Love’s Short Practice of Surgery
3. PERITONEAL LAVAGE
In surgery for general peritonitis it is essential that after the cause has been dealt with, the whole peritoneal cavity should be explored with the sucker and mopped dry, if necessary until all seropurulent exudate is removed. The use of a large volume of antibiotic saturated saline (1-2 litres) has been shown to be very effective for cleaning the peritoneum (Matheson). (pp 1105)
Bile peritonitis – Unless there is reason to suspect that a bile duct was damaged, it is improbable that bile as a cause of peritonitis will be thought of until the abdomen has been opened and bile is seen therein. The common causes of bile peritonitis are: (1) following biliary surgery, e.g., damage to the common bile duct, slipping of a ligature on the cystic duct, leakage from a divided accessory bile duct in the gall bladder bed or dislodgement of a T-tube drain in the early postoperative phase; (2) following perforation or gangrene of the gall bladder or leakage from a choledochus cyst; and (3) following gastroduodenal surgery, e.g., duodenal cap ‘blow out’ or leakage from a suture line.
Unless the bile has extravasated slowly, when the collection becomes shut off from the general peritoneal cavity, there are signs of diffuse peritonitis with a degree of shock. After a few hours a tinge of jaundice is not unusual. Local drainage, and when necessary suprapubic peritoneal drainage, is imperative, and if performed early enough, these measures will save the patient’s life. When bile is seen issuing from perforation of some part of the biliary tree, a drainage tube should be passed through the opening and secured there. Infected bile is more lethal than sterile bile. The gall bladder, if present, should be drained. A blown duodenal stump must be drained as it is too oedematous to repair, but sometimes it can be covered by a jejunal patch. If the patient is jaundiced the surgeon must ensure that the abdomen is not closed until any possible cause of obstruction to a major bile duct has been either excluded or relieved.
(b) British Journal of SURGERY
1989, Vol 76, October 1046 – 1048
Bile leaks after simple cholecystectomy
Z. Rayter, C. Tonge, C.E. Bennett, P.S. Robinson, and M.H. Thomas
It is likely that the bile leakage comes from small biliary radicles damaged by dissection of the gallbladder bed. Bile and blood have previously been shown to be readily reabsorbed by the peritoneum. None of these leaks was clinically significant, and no patient developed a complication specifically related to bile leakage. We suggest that it is the introduction of infection into these harmless bile leaks as may happen with the placing of a drain, that can render them potentially dangerous.”
Even a plain reading of the conclusion of this article would show that it is hardly relevant because in this case, a drain was placed immediately after the surgery.
(c) British Journal of SURGERY
1999, 86, 1020 – 1024
Bacterial infection and extent of necrosis are determinants of organ failure in patients with acute necrotizing pancreatitis
- R. Isenmann, B. Rau and H. C. Berger xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
We have not extracted any part of this article because we do not see its link with the allegations against the respondent or with his defence, except to the extent that one of the precipitating causes of Reeta’s death was acute pancreatitis, which she developed after the ERCP while at the PGI.
(d) Tropical Gastroenterology – Vol. 15, No. 1, 1994, Page: 19-22
ENDOSCOPIC SPHINCTEROTOMY FOR COMMON BILE DUCT STONES WITH AND WITHOUT GALLBLADDER / ’T’ TUBE ‘IN SITU’
Virendra Singh, Kartar Singh, Prakash Kumar, Vijay Prakash, H. S. Rai,
A. Kumar, B. K. Agarwal
We have not found it necessary to quote from this article also because of its obvious lack of relevance to the case in hand, as even the title of the article would show – Reeta’s ailment was not due to any stone in the CBD.
Seymour I Schwartz, MD
Harold Ellis, DM, MCh, FRCS
With Wendy Cowles Husser, MA
Bile peritonitis is an uncommon abdominal catastrophe. However, in spite of its rarity, it forms a subject of considerable interest because of the wide range of pathologic processes, some but poorly understood, that give rise to this condition. In a review of 22 patients with bile peritonitis, we suggested the following classification (Ellis and Cronin, 1960):
1. Traumatic rupture of the gall bladder or bile ducts by either a penetrating wound or closed injury.
- 2. Postoperative leakage following surgical procedures on the biliary tract.
3. Perforation of the acutely inflamed gall bladder or duct.
4. Transudation of bile through the walls of a gangrenous but nonperforated gall bladder.
5. Rupture of a subcapsularcholangitic abscess of the liver in cholangiohepatitis.
6. Perforation of an apparently normal gall bladder or duct.
7. Idiopathic – i.e., where there is no demonstrable pathology in the biliary tract.
Two conditions must be differentiated from bile peritonitis. These are when the duodenal contents that escape on perforation are heavily bile stained, and the bilious ascites that may occur in hepatic obstruction.
McKenzie (1955) divides postoperative leakage into five groups; (1) slipping of a ligature on the cystic duct, (2) operative damage to the duct, (3) leakage from accessory ducts in the gall bladder bed (4) escape of bile from a dislodged common bile duct drainage tube, and (5) seepage through the suture line in the common duct. He makes the important point that it is often impossible to find the source of leakage at subsequent laparotomy or even autopsy examination, and this was so in 12 of 20 collected cases. Rupture of the ducts may occur as a late affair weeks or even months after cholecystectomy, usually as the result of stones left over looked in the common duct.
Two types of clinical picture have been described that can be correlated to some extent with the main aetiologic groups that we have discussed. Perforation that complicates acute cholecystitis invariable presents acutely, often associated with jaundice and shock. Postoperative bile peritonitis usually presents with a similar clinical picture of acute pain and peritonitis. However, some examples of postoperative leakage present more insidiously, with only mild abdominal pain and tenderness, abdominal distension and signs of free fluid. Rosato et al (1970) describe two such indolent examples. This also seems to be the usual manner of presentation in infants and may be due to the relatively slow leak of bile and the absence of infection.
(f) Michael J. Zinner, Seymour I Schwartz, Harold Ellis
“Second, presentation in the postoperative period may be as biliary peritonitis. This situation is serious, and the patient is often desperately ill, especially if the bile is infected. However, in some patients with sterile bile, huge volumes may accumulate within the peritoneal cavity without overt signs of shock.Management of these cases demands closure of the biliary peritoneal fistula to prevent death. Definitive repair is seldom possible since the bile ducts are collapsed and the tissues, deeply stained with bile, are friable. External drainage is the best initial approach. Such drainage may be carried out through a mobilized Roux-en Y loop of jejunum, with the external drainage tube simply being fed in a transjejunal fashion to the exterior. Such a procedure allows initial control, and the almost certain need for reoperation for stenosis at a later date should be accepted.
(g) Bailey and Love’s Short Practice of Surgery
We have refrained from quoting from this source because it is essentially a repetition of what has been stated in the Twenty-First edition quoted above.
(v) With due respect to the abovementioned literature, we feel that, to address the issues involved in this case, it would be necessary to read some more literature on the subject. Thus:
(a) “TEXT BOOK OF GASTROENTEROLOGY (Volume 2), 5th Edition
Edited by Tadataka Yamada
Published by Wiley Black
(Pages 1966 – 1967)
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxAserious direct complication of laparoscopic cholecystectomy is injury to the common bile or hepatic ducts. This may result from misidentification of the common duct for the cystic duct, resection of part of the common and hepatic ducts, or associated right hepatic arterial injury. The estimated incidence of bile duct injury varied from 0.3% – 2.7%. In contrast, biliary tract injuries are estimated to occur in 0.25% – 0.5% in open cholecystectomies. A major risk factor for bile duct injury is the experience of the surgeon. Bile duct injuries appear to be much more common early in a surgeon’s experience with the technique. Other risk factors appear to be the presence of aberrant biliary tree anatomy and the presence of local acute or chronic inflammation. Intraoperative cholangiography may reduce the risk of bile duct injuries. Bile leaks may also develop as the result of displacement of the operative clips on the cystic duct.
Bile duct injury leads to two clinical manifestations; bile leakage into the peritoneum, with resulting abdominal pain and bile peritonitis, or bile obstruction as the result of partial or complete hepatic or common duct obstruction from ductal ligation or stricture. Patients can present 3-7 days after surgery with fever, abdominal pain, anorexia, ileus, ascites, nausea or jaundice. Patients with late – onset stricture may present months later with jaundice. Biliary scintigraphy using 99mTc – IDA can be used to diagnose bile leakage. ERCP with stent placement or sphincterotomy can be used both diagnostically and therapeutically. ERCP appears to be the treatment of choice for less severe lesions, such as minor lacerations of the common bile duct. It may also be used to treat bile leakage because of displaced cystic duct clips. Lesions in the proximal biliary tree may be more amenable to percutaneous transhepatic approaches. Surgical repair may be necessary in some patients, such as those with transected common bile ducts. Intraabdominal bile collections may need to be drained percutaneously.
Certain clinical scenarios remain controversial, such as the management of patients with acute cholecystitis; in particular, the timing and route of cholecystectomy. Although laparoscopic cholecystectomy has been performed successfully in acute cholecystitis, this group of patients has a higher incidence of common bile duct stones, and the procedure may be technically more difficult and last longer. In this setting, intraoperative cholangiograms may be more difficult to obtain and bile duct injuries more common. Randomized trials comparing early surgery (<3 days) with delayed surgery (4-6 weeks) for acute cholecystitis show no benefit to delaying surgery. Patients in the early surgery group had longer operating times, but they had similar rates of conversion to open cholecystectomy and shorter hospital stays. Laparoscopic cholecystectomy appears to provide similar outcomes compared to open cholecystectomy in this setting. Early cholecystectomy for acute cholecystitis, initially using laparoscopic route, may therefore be appropriate.
Conversion to an open cholecystectomy should be undertaken if the operative field is not adequately visualised or variant anatomy is encountered. Conversion to an open procedure should not be considered a complication. In most series, conversion rates are higher with emergency operations. Reported rates range from 1.5% – 15%, with most reporting rates around 5%. With experience, the operative conversion rate appears to fall.
Many studies suggest that the indications for cholecystectomy are broader with the availability of laparoscopy. Cholecystectomy may be performed in some patients whose symptoms are not clearly biliary in origin. In contrast, some patients with symptomatic gallstones may not receive surgery in a timely fashion. Glasgow and colleagues found that 1.3 per 1000 people underwent cholecystectomy for symptomatic gallstone disease in California in 1996. Of these, 56% had biliary colic, and the remainder had more severe complications such as acute cholecystitis, gallstone pancreatitis, or cholangitis. Patients presenting with biliary colic were more likely to undergo laparoscopic surgery electively, while those with the more severe complications were more likely to require an emergency or open procedure. In many patients, surgery was significantly delayed after the development of initial symptoms. Patients being treated for complicated gall stone disease had significantly longer hospital stay and costs. There is evidence for both underuse and overuse of laparoscopic cholecystectomy. Clarifying the appropriate indications for surgery and ensuring timely recognition and treatment of gallstone symptoms remain as priorities to improve clinical care of these patients.
Stones may be removed from the common bile duct by means of ERCP with sphincterotomy. Larger stones may require mechanical lithotripsy. In the postoperative period, endoscopic and radiographic techniques may be used to extract stones through a T-tube tract. Stones may be extracted or fragmented with the help of a choledochoscope. In all of these modalities, the gallbladder is left in situ, allowing the possibility of recurrent stone formation. Patients undergoing sphincterotomy alone for treatment of their gallstone disease have a much higher rate of future biliary complications than patients who also undergo cholecystectomy. Therefore, cholecystectomy should be considered in all patients who have common bile duct stones even if a sphincterotomy is performed.”
(vi) The next piece of medical literature that is necessary to read is the section in Bailey and Love’s Short Practice of Surgery, dealing with open cholecystectomy (the surgical procedure stated to have been adopted by the respondent). Thus,
Bailey and Love’s Short Practice of Surgery, 25th Edition
Edited by Norman S. Williams
Christopher J. K. Bulstrode
& P. Ronan O’Connell
(Pages 1124 – 1126)
For patients in whom a laparoscopic approach is not indicated or in whom conversion from a laparoscopic approach is required, an open cholecystectomy is performed.
A short right upper transverse incision is made centred over the lateral border of the rectus muscle. The gall bladder is appropriately exposed, and packs are placed on the hepatic flexure of the colon, the duodenum and the lesser omentum to ensure a clear view of the anatomy of the porta hepatis. These packs may be retracted using the hand of the assistant (‘it is the left hand of the assistant that does all the work’ – Moynihan), or a stabilised ring retractor is used to keep the packs in position. A Duval forceps is placed on the infundibulum of the gall bladder, and the peritoneum overlying Calot’s triangle is placed on a stretch. The peritoneum is then divided close to the wall of the gall bladder, and the fat in Calot’s triangle is carefully dissected away to expose the cystic artery and the cystic duct. The cystic duct is dissected to the common bile duct, whose position is clearly ascertained. The cystic artery is tied and divided. The whole of the triangle of the Calot is displayed to ensure that the anatomy of the ducts is clear and the cystic duct is then divided between ligatures. The gall bladder is then dissected away from the gall bladder bed.
Some golden rules in case of difficulty:
- When the anatomy of the triangle of Calot is unclear, blind dissection should stop.
- Bleeding adjacent to the triangle of Calot should be controlled by pressure and not by blind clipping or clamping.
- When there is doubt about the anatomy, a ‘fundus-first’ or ‘retrograde’ cholecystectomy dissecting on the gall bladder wall down to the cystic duct can be helpful.
- If the cystic duct is densely adherent to the common bile duct and there is the possibility of a Mirizzi syndrome (a gallstone ulcerating through into the common duct), the infundibulum of the gall bladder should be opened, the stone removed and the infundibulum oversewn.
- A cholecystostomy is rarely indicated but, if necessary, as many stones as possible should be extracted, and a large Foley catheter (14 F) placed in the fundus of the gall bladder with a direct track externally. By so doing, should stones be left behind in the gall bladder, these can be extracted with a choledochoscope.
Late symptoms after cholecystectomy
In 15% patients, cholecystectomy fails to relieve the symptoms for which the operation was performed. Such patients may be considered to have a ‘post-cholecystectomy’ syndrome. However, such problems are usually related to the preoperative symptoms and also merely a continuation of these symptoms. Full investigation should be undertaken to confirm the diagnosis and exclude the presence of a stone in the common bile duct, a stone in the cystic duct stump or operative damage to the biliary tree. This is best performed by MRCP or ERCP. The latter has the added advantage that, if a stone is found in the common bile duct, it can be removed.
Management of bile duct obstruction following cholecystectomy
Patients with symptoms developing either immediately or delayed after a cholecystectomy, particularly if jaundice is present, need urgent investigation. This is especially true if the jaundice is associated with infection, a condition called cholangitis.
The first step in management is to undertake an immediate ultrasound scan. This will demonstrate whether there is intra-or extrahepatic ductal dilatation. The anatomy needs to be defined by either an ERCP or an MRCP. The latter investigation will also allow for therapeutic manoeuvres such as removal of an obstructing stone or insertion of a stent across a biliary leak. If a fluid collection is present in the subhepatic space, drainage catheters may be required. These can be inserted under radiological control or, if this expertise is not available, at open operation. Small biliary leaks will usually resolve spontaneously, especially if there is no distal obstruction. Should the common bile duct be damaged, the patient should be referred to an appropriate expert for reconstruction of the duct.
About 15% injuries to the bile ducts are recognised at the time of operation. In 85% of cases, the injury declares itself post-operatively by: (1) a profuse and persistent leakage of bile if drainage has been provided, or bile peritonitis if such drainage has not been provided; and (2) deepening obstructive jaundice. When the obstruction is incomplete, jaundice is delayed until subsequent fibrosis renders the lumen of the duct inadequate.
Any change in bilirubin or suggestion of duct damage requires investigation and the nature of the bile duct injury clarified. The surgical repair and subsequent outcome is related to the level of injury, which is determined using the Bismuth classification (Table 63.1)
Type I Low common bile duct; stump >2 cm
Type II – Middle common hepatic duct; stump <2cm
Type III – Hilar-confluence of right and left ducts intact
Type IV – Right and left ducts separated
Type V – Involvement of the intrahepatic ducts.
In the debilitated patient, temporary external biliary drainage may be achieved by passing a catheter percutaneously into an intrahepatic duct. Also, stents may be passed through strictures at the time of ERCP and left to drain into the duodenum. When the general condition of the patient has improved, definitive surgery can be undertaken. The principles of surgical repair are maintenance of duct length and restoration of biliary drainage. For benign stricture or duct transection, the preferred treatment is immediate Roux-en-Y choledochojejunostomy by an experienced surgeon. For a stricture of recent onset through which a guidewire can be passed, balloon dilatation with insertion of a stent is an acceptable alternative provided that the services of an experienced endoscopist are available. The outcome of such surgery is good, with 90% of patients having o further cholangitis or stricture formation.”
(vii) We may now read a short article of direct relevance to one of the medical symptoms that Reeta developed, namely, Jaundice. Though this article is of 2007, the main thrust of reading/referring to it is to understand the standard treatment of obstructive jaundice, which was recorded as one of the post-cholecystectomy ailments of Reeta. However, we have omitted the Tables of data, as they are mainly illustrative of the points made in the body of the article.
SURGERY 25:2 74 © 2007 Published by Elsevier Ltd.
Investigation and management of obstructive jaundice
C D Briggs, M Peterson
Obstructive jaundice is a medical emergency. Local guidelines should be in place and widely publicized to facilitate timely investigation and management and avoid complications. Management must involve a multidisciplinary team that can offer a full range of investigative techniques (cross-sectional imaging, percutaneous procedures, endoscopic retrograde cholangiopancreatography).
Keywords obstructive jaundice; cholestasis; gallstones; cholangiocarcinoma; Klatskin tumour; pancreatic cancer; bile duct stones; biliary stricture; cholecystectomy
Jaundice can be defined as an increase in the concentration of bilirubin in serum leading to the clinical manifestation of yellowing of the skin and sclera (icterus). This may be secondary to partial or complete obstruction of the outflow of bile and its components from the liver into the alimentary tract (cholestasis).
Cholestasis may occur within the liver in the hepatic ductules (hepatic cholestasis) or in the extrahepatic bile duct system due to mechanical obstruction (extrahepatic cholestasis or obstructive jaundice).
Obstructive jaundice is not a definitive diagnosis and early investigation to find the cause of cholestasis is of great importance because pathological changes (e.g. secondary biliary cirrhosis) can occur if obstruction is unrelieved.
This contribution discusses the initial investigative process, potential diagnoses and therapeutic alternatives that may be encountered.
Pre-hepatic jaundice is due to increased bilirubin load on the hepatocytes (usually due to haemolysis). The increase in serum bilirubin is mainly unconjugated and the concentrations of transaminases and alkaline phosphatase are normal.
Hepatic jaundice is failure of excretion of bile from the hepatocytes. Conjugated serum bilirubin is raised. Transaminases are raised, dependent on the cause (e.g. viral or drug-induced).
Cholestatic jaundice is caused by failure of formation of bile or of bile transport. This may occur at any point from the hepatocyte to the ampulla of Vater. Serum conjugated bilirubin is elevated and alkaline phosphatase is increased. Cholestatic jaundice may be intra- or extra-hepatic (vide infra).
Careful history-taking, clinical examination and investigations point to the cause of jaundice (Table 1). Serum biochemistry confirms the diagnosis of jaundice with an elevated serum bilirubin, usually ≥40 μmol/l when detectable clinically. An obstructive pattern is recognizable in the other liver function tests, i.e., a high alkaline phosphatase and only mild increase in the concentration of transaminases (Table 1).
Having diagnosed a cholestatic picture, the priority is to establish whether there is biliary dilation, which differentiates extrahepatic cholestatic jaundice, or obstructive jaundice from intrahepatic causes. This is most easily assessed by ultrasonography.
• shows the size of the bile ducts
• defines the level of the obstruction
• identifies the cause (in some cases)
• gives other information related to the disease (e.g. hepatic metastases, gallstones, hepatic parenchymal change). The level of biliary obstruction will help to guide further investigation (Figure 1) if the cause of the obstruction is not apparent.
Distal obstruction – dilation of the intra- and extrahepatic bile ducts is present; most patients will have a gallstone in the common bile duct (see below) or carcinoma of the head of pancreas (see below). Both diagnoses may be apparent on ultrasound, but often the distal bile duct is poorly seen with ultrasound due to overlying bowel gas. Distal obstruction may also be caused by a duodenal or ampullary lesion. These can be investigated by duodenoscopy and biopsied if directly seen.
Proximal obstruction – proximal biliary dilation usually results from obstruction at the porta hepatis and is recognized by dilation of the intrahepatic ducts without enlargement of the distal common bile duct. This is an uncommon finding, but is the classical appearance of a hilar cholangiocarcinoma (Klatskin tumour). Other disease processes may simulate this appearance. Local infiltration of a gallbladder tumour, severe inflammation in the gallbladder causing compression of the extrahepatic biliary tree (Mirizzi syndrome) or metastatic malignant disease in and around the porta hepatis may give rise to hilar biliary obstruction. Further cross-sectional imaging is required to elucidate the cause.
Dilated common bile duct only – isolated dilation of the common bile duct may be present with abnormal liver function in certain special cases. of portal hypertension may be present, indicating chronic underlying liver disease as the possible cause. Further imaging is unlikely to be helpful in the absence of biliary dilation or other abnormality on ultrasound, and investigation should focus on the medical causes of jaundice. Ultrasound assessment may be suboptimal in some cases (e.g., obesity) and further imaging with CT or MRCP is appropriate. Biliary stenting to relieve obstruction and a biopsy for histological confirmation may be undertaken if metastatic disease is present. Liver biopsy is contraindicated if there is an obstruction of the bile duct due to the risk of a bile leak and subsequent biliary peritonitis. A biopsy of the primary lesion is therefore often taken during placement of a biliary stent. Figure 3 shows an imaging algorithm for assessing jaundice.
(vii) The next piece of medical literature that we would like to refer to is also a research article but of May 2000, i.e., contemporaneous with the surgery in this case. This article provides, with detailed reasons, some illuminating clarifications on how to deal with post-cholecystectomy complaints of pain, discomfort, etc., when these symptoms are mild. In reproducing this article, we have omitted the Tables and also some paragraphs as well as the references, which can be easily read by referring to the original article available on the JAMA (Journal of American Medical Association) website.
“Postcholecystectomy Abdominal Bile Collections
Lawrence W. Way, MD; Lygia Stewart, MD; Crystine M. Lee, MD
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.
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 Thisstudy defines the syndromes associated with abdominal bile collections and shows how best to manage patients with this problem.
TYPE AND LOCATION OF BILIARY INJURIES
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.
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.
PATIENTS WITH SERIOUS COMPLICATIONS
The initial clinical presentation was not different between those who developed serious complications and those who did not.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
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 … … …
To define the biliary anatomy, a percutaneous transhepatic cholangiography was obtained in 73% of cases and endoscopic retrograde cholangiopancreatography (ERCP) in 70%.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
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.
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.
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.
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.
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 (e.g., 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 situation. 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. Then, a specific operative treatment plan can be devised.
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 (e.g., 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 (i.e., 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 (i.e., 6-0, 5-0, or 4-0), absorbable, monofilament suture. End-to-end repairs of injured bile ducts are rarely successful.
(viii) The last piece of medical literature that we would cite is also an article, published in 2001 in the Official Journal of the International Hepato-Pancreato-Biliary Association, Americas Hepato-Pancreato-Biliary Association and European-African Hepato-Pancreato-Biliary Association and available free on the websitehttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC2020798/. In quoting from this article we have omitted the details, Tables and references in most sections, except the Results and Discussion, which are reproduced in full:
“Minimally invasive management of bile leak after laparoscopic cholecystectomy
Bile leakage is an uncommon complication of cholecystectomy. The bile may originate from the gallbladder bed, the cystic duct or rarely from injury to a major bile duct. This study aims to evaluate the efficacy of minimal access endoscopic and percutaneous techniques in treating symptomatic bile leak.
Patients and methods
Twenty-one patients with symptomatic bile leak following laparoscopic cholecystectomy underwent assessment of the extent of the bile leak via ultrasound/CT and ERCP. Following diagnosis, the patients were treated by sphincterotomy and biliary drainage and, if necessary, percutaneous drainage of the bile collection.
Percutaneous drainage of a collection under US/CT guidance was used before ERCP in six patients and laparoscopic lavage in three before ERCP. In another patient, laparoscopic lavage was performed in the immediate post-ERCP period. One patient also required chest drainage of a right-sided emphysema complicating a subhepatic collection.
Common bile duct (CBD) cannulation and cholangiography at ERCP was successful in all cases. In one referred patient, cholangiogram revealed complete division of the right hepatic duct, and this patient subsequently underwent Roux-en-Y hepaticojejunostomy. Cystic stump leak was documented in 16 cases. In four patients choledocholithiasis was present; in three of these, bile duct stones had been noted at intra-operative cholangiography, and a decision had been made to treat them by postoperative ERCP and sphincterotomy. In these patients, the bile leak was unsuspected and only noted at the time of ERCP. Common hepatic duct (CHD) leak was present in three cases (one with choledocholithiasis), and leakage from the choledochotomy site was demonstrated in the patient who had undergone laparoscopic exploration. Endoscopic treatment was attempted in 20 of the 21 patients (95%); the patient with complete transection of the right hepatic duct (Strasberg type C injury) underwent open reconstruction. Endoscopic sphincterotomy was used alone in five cases, in combination with stent placement in 13 cases, in combination with nasobiliary catheter in one, while in one patient a stent was placed without sphincterotomy. There was only one complication relating to the endoscopic procedure; this patient developed pancreatitis of moderate severity, which settled conservatively after a 7-day stay in hospital. Another patient developed deep venous thrombosis during hospitalisation with no further consequences.
Bile leaks have been reported more commonly after laparoscopic than cholecystectomy and usually occur as a result of injury to a minor duct that remains in continuity with the CBD, a type A injury according to the Strasberg classification. The cystic duct stump and small peripheral right hepatic ducts within the liver bed account for most injuries of this type; those originating from the liver bed often remain asymptomatic. When symptomatic they present with pain, nausea, vomiting, abdominal distension, fever and jaundice or bile leakage in a surgical drain. Cystic stump leaks can occur from faulty clip application, slipping of the clips or necrosis of the cystic duct stump proximal to the clip, probably related to diathermy injury. Retained CBD stones can increase intraluminal pressure and therefore promote bile leakage, as seemed to be the case in three of our patients.
The ideal endoscopic approach – whether endoscopic sphincterotomy, long versus short stent placement or nasobiliary tube drainage – has not yet been established. It largely depends on personal experience based on small series, there being no prospective comparative studies. The use of endoscopic sphincterotomy to reduce distal bile duct pressure and facilitate closure of leaking cystic ducts is well described. Short stent placement, if possible without sphincterotomy so as to avoid sphincterotomy complications, was thought to achieve the same purpose, as it effectively eliminates sphincter resistance. However, reduction in intraductal pressure is only part of the leak closure process, as illustrated by our one failure in a patient with sphincterotomy alone without stenting. By contrast, stent placement not only satisfies the pressure reduction criterion but also ‘covers’ the leaking point and allows it to heal.
Nasobiliary tube placement has been used variably. It avoids the need for a second ERCP, but at the expense of disadvantages such as the risk of accidental tube removal, patient discomfort and inconvenience. Furthermore, a higher failure rate has been reported, although comparative studies do not exist. In a recent series 18 out of 19 patients with cystic duct leak were treated successfully with nasobiliary tube drainage, saving the patients a repeat ERCP.
Most published series focus on the role of ERCP in the diagnosis of bile leak after laparoscopic cholecystectomy, but in many cases endoscopic management can treat the original cause of the problem, i.e. stop the leak. Supplementary measures may be required to deal with the localised or diffuse bile collections secondary to the leak. In this series, a combination of endoscopic and radiological or laparoscopic procedures was used successfully, avoiding the need for open intervention in all but one patient.
This series is complementary to previous reports that confirm the safety and efficacy of minimally invasive procedures in the management of symptomatic bile leak following minor biliary injuries associated with laparoscopic cholecystectomy. Endoscopic treatment by means of ERCP is the cornerstone of management, supplemented by either interventional radiological or laparoscopic procedures.
SUMMARY OF MEDICAL LITERATURE
- Thus, after extensive review of medical literature on post-cholecystectomy complications from a wide variety of sources, we find that the standard view on the subject can be summarised as under:
- Anatomically, the biliary tree consists of the left and right hepatic ducts joining to form the common hepatic duct, cystic duct from the gallbladder joining the common hepatic duct to form the common bile duct (CBD) and CBD and the pancreatic duct joining together at the ampulla of Vater in the D2 (second) part of the duodenum.
- With laparoscopic cholecystectomy widely replacing open cholecystectomy, the incidence of post-operative bile leakage due to iatrogenic (any adverse condition in a patient resulting from treatment by a physician or surgeon) injuries to the common bile duct or any of the preceding biliary ducts has increased more than two-fold. However, even then, it remains a “known complication” with a low probability/incidence (0.3% – 2.7%, i.e., 3-27 in 1000 cases of LC and 0.25% – 0.5%, i.e., 2.5-5 in 1000 cases of OC). Bile leakage due to slipping of the ligature of or injuries to the cystic duct is also a known complication. Cystic stump leaks can occur from faulty clip application, slipping of the clips or necrosis of the cystic duct stump proximal to the clip, probably related to diathermy injury.
- c. ‘When the anatomy of the triangle of Calot is unclear, blind dissection should stop.’ The ‘triangle of Calot’ is the triangular anatomical space bounded by the cystic duct – inferiorly, cystic artery – superiorly and the common hepatic duct – medially). ‘Dissection in the triangle of Calot is ill-advised until the lateral-most structures have been cleared and identification of the cystic duct is definitive. According to SESAP 12 (produced and distributed by the American College of Surgeons) dissection in the triangle of Calot is the #1 cause of common bile duct injuries’ (vide http://en.wikipedia.org/wiki/Cystohepatic_triangle).
- A major risk factor for bile duct injury is the experience of the surgeon. Bile duct injuries appear to be much more common early in a surgeon’s experience with the technique. Other risk factors appear to be the presence of aberrant biliary tree anatomy and the presence of local acute or chronic inflammation.
e. ‘In 85% of cases, the injury declares itself post-operatively by: (1) a profuse and persistent leakage of bile if drainage has been provided, or bile peritonitis if such drainage has not been provided; and (2) deepening obstructive jaundice. When the obstruction is incomplete, jaundice is delayed until subsequent fibrosis renders the lumen of the duct inadequate.’
- ‘Careful history-taking, clinical examination and investigations point to the cause of jaundice. Serum biochemistry confirms the diagnosis of jaundice with an elevated serum bilirubin, usually ≥40 μmol/l when detectable clinically. An obstructive pattern is recognizable in the other liver function tests, i.e., a high alkaline phosphatase and only mild increase in the concentration of transaminases.’
- For patients ‘who have anything less than a smooth postoperative course’, diagnostic imaging is warranted ‘even in the absence of pain, fever, leukocytosis, or abdominal tenderness.’
- h. ‘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 drainage of bile collection but before starting any definitive line of treatment, ERCP (or, MRCP) is the procedure of widest choice to determine the source of the bile leakage and/or the existence of stone and/or stricture in the biliary tree anatomy. The former has the added advantage of therapeutic use in certain situations.
- Reverting to the expert opinion and the contentions of the parties thereon (paragraphs 10-12), we deem it necessary to see if it is prima facie clear that in arriving at its conclusions, the Medical Board considered the entire medical record of Reeta’s treatment at the respondent’s Centre.
(i) The first, rather unusual aspect that comes to notice is that before the State Commission (and also among the documents filed during hearing of the appeal), there were two sets of medical records: one that was given to the complainant by the respondent/OP and filed by the former along with the complaint with a complete index and the other that was filed by the respondent with his written version: the medical record filed by the respondent has many more pages and, on most of the comparable pages, it has more details.
(a) For example, the ‘Operation Notes’ on the cholecystectomy (apparently recorded by the respondent in his own hand) in the set of papers given to the complainant read as under:
“Date Operation SURGEON P. N. GUPTA
D 11/9/00 Anaesthetist
- Dr. Suchi (Illegible)
(Under – downward arrow sign) GA with all aseptic care
Gallbladder – (Illegible)
Cystic duct & artery ligated
with 2-0 vikryl
Suturing done (Illegible)
putting (Illegible) corrugated drainage tube
Sd/- P.N. Gupta”
(b) On the other hand, the ‘Surgeon Notes’ filed by the respondent (much after the complainant filed the records given to him by the Centre with his complaint, copy of which was surely given to the respondent) read as under:
(Under – downward arrow sign) GA with all aseptic care
Path – Gallbladder distended adherent
to all surrounding structures, thick wall
CBD – palpated. No stone
Cystic duct and artery could not be
separated individually. Using 1-0 vikryl suture ligation done
Complete gallbladder removed
Corrugated drainage tube was
put in gall bladder fossa,
gallbladder sent for histopath
Sd/- P.N. Gupta”
(c) Neither Note, however, recorded that a Laparoscopic Cholecystectomy (LC) was attempted, abandoned and converted into Open Cholecystectomy (OC) in view of adhesions of the gallbladder to the surrounding structures (though the latter fact was mentioned in the Surgeon Notes). The Anaesthetist’s Notes filed by the respondent also do not clarify if LC was attempted and then converted to OC. This point is of some significance because in an OC the post-operative hospital stay of the patient is considerably longer as both common experience and medical research papers show.However, in this case, though Reeta underwent (LC converted to) OC on 11.09.2000, she was admittedly released from the Centre the very next day, i.e., 12.09.2000!
(d) The standard requirement in case of an OC is to record the basic details of the surgical process – this was not done nor was the standard note on “closing the wound” recorded. Moreover, the ‘Surgeon Notes’ filed by the respondent did not mention if there was any calculus at all, though the ‘Operation Note’ given to the complainant mentioned ‘M. calculi (presumably meaning, multiple calculi).
(e) That the CBD was not only fully visualised but also palpated and no stone was found therein and that the gallbladder was fully removed were mentioned only in the ‘Surgeon Notes’ (and not in the Operation Notes) but strangely, the former Notes failed to mention if there was any stone at all in the gallbladder – something that was mentioned in the ‘Operation Note’ as ‘M. calculi’!
(f) Even the size (represented by diameter of individual suture strands) of the ‘vikryl’ suture (the term is actually ‘vicryl’, a trade-name of a widely used variety of absorbable surgical sutures manufactured by a subsidiary of Johnson & Johnson) is recorded as 2-0 in the Operation Notes and 1-0 in the Surgeon Notes. 1-0 stands for a thicker diameter, representing higher tensile strength of the suture strands. The variation in thickness has an important bearing on the stability of the sutures in holding up the ligated ducts/arteries.
(f) More important, both the Notes mention that the cystic duct and the cystic artery could not be separated, i.e., the triangle of Calot could not be fully exposed. In such a situation, the strong advice (termed one of the ‘Golden Rules’) in Bailey & Love’s Short Practice of Surgery (a medical textbook cited by the respondent) is: ‘When the anatomy of the triangle of Calot is unclear, blind dissection should stop.’ and ‘Dissection in the triangle of Calot is ill-advised until the lateral-most structures have been cleared and identification of the cystic duct is definitive.’ (vide para. 14 c. above). The respondent, however, went ahead with the ligation of both the cystic duct and the cystic artery and claimed it to be a successful surgery – obviously, since the two could not be separated, they were ligated together! It is highly doubtful if this is a standard practice in such a situation –the medical literature cited by the respondent or those reviewed by us does not say it is.
(ii)(a) Among the numerous photocopies of handwritten medical and nursing notes as well as of typed diagnostic reports relating to Reeta filed by the respondent, there is no copy of the Discharge Summary of 12.09.2000 though there is a photocopy of the Discharge Summary dated 12/(13?).10.2000. On the other hand, among the papers filed by the complainant before the State Commission, there is a page, not designated as “Discharge Summary” but containing some comparable entries dated 12.09.2000 as under:
1. Tab Atenol 25 mg *‑‑‑‑‑‑‑‑‑‑‑‑‑*
2. Tab Daovil 1‑‑‑‑‑‑‑‑‑‑‑‑‑1/2
3. Tab Cifran CT
after BF *‑‑‑‑‑‑‑‑‑‑‑‑‑* (Dinner)
for 5 days
4. Tab Droxyl – 500 *‑‑‑‑‑‑‑‑‑‑‑‑‑‑*
for 7 days
5. Tab Rantac – 150 mg *‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑*
6. Tab (Illegible) Forte 1 OD
after 7 days for stitch removal.
Sd/- P.N. Gupta”
(b) This page also has two more entries, both undated and unsigned recording as under:
“Liq. Cremaffin Pink 3 TSF HS with milk
Isogel 3-4 TSF AN”
(iii) In the complaint as well as the OP’s written version, the date of post-operative visit of the patient to the Centre for removal of stitches was stated to be 20.09.2000. However, in the ‘Brief History’ recorded on 12.10.2000 by way of reference to Dr. Neeraj Nagpal (who performed the unsuccessful ERCP on Reeta), the date of removal of stitches was shown as 22.09.2000.
(iv) In the ‘Brief History’ for reference to Dr. Neeraj Nagpal, it was also recorded, “Patient had mild pain throughout”, below the entry “22/9/00 – Removal of stitches” and thereafter, “On 27th Pt had sudden pain, was unable to move.”
(v)(a) The complainant alleged that the Reeta and he went to the Centre on 25.09.2000 and Reeta complained of continuing stomach pain and constipation. The respondent prescribed Liq. Cremaffin. On 28.09.2000, they again went to see the respondent at his Centre with the same complaint of pain and constipation but, after examination, the respondent only prescribed Isabgol.
(b) However, in his written version, the respondent denied altogether the visit of the patient on 28.09.2000 stating, “As per the history record patient never visited as claimed … …” Yet, the fact remains that as per the record made available to the patient, even their visit of 25.09.2000 when Liq. Cremaffin was prescribed (which the respondent also admitted in the written version) did not have any entry except the undated prescription of Liq. Cremaffin (vide sub-para (ii)(b) above). So, the respondent’s denial of the visit of the patient and her husband/complainant on 28.09.2000 on the strength of absence of any entry in the “history record” of the Hospital/Centre is rather strange.
(c) It cannot also be overlooked that in the ‘Brief History’ referred to above (recorded by the respondent in his own hand), the complaint of sudden pain suffered by Reeta on 27.09.2000 (because of which she was unable to move) was specifically mentioned. If Reeta did not complain of any serious pain nor did she come to the Centre on 28.09.2000, as claimed by the respondent, how did he ascertain this fact and why did he find it necessary to make this specific entry with date in his reference to Dr. Nagpal?
(vi)(a) Further, the respondent called for ultrasonography of Reeta’s abdomen on 02.10.2000, which was done the same day. The findings included ‘minimalcollection of fluid’ ‘in the peritoneal cavity, in paracolic gutters, in the pelvis and around the liver’, and normal calibre of the CBD, with no evidence of stone in the visualised portion thereof. It is rather surprising that though the ultrasonography report mentioned fluid collection in practically all relevant regions of the peritoneum, including its deepest (i.e., the pelvis), it was still described as ‘minimal’ by the Radiologist. Be that as it may!
(b) According to the respondent, a second abdominal ultrasonography was done on 03.10.2000 because, on seeing the report of 02.10.2000, the ‘OP had doubt of Biliary Leak.’ According to him, this ultrasonography report (i.e., that of 03.10) ‘showed more collection of fluid in the peritoneal cavity’ and that led him to do needle aspiration of fluid from the Pouch of Douglas (the extension of the peritoneal cavity between the rectum and back wall of the uterus in the female human body, i.e., deep inside the pelvic region) in the evening of 03.10.2000, draining about 100-150 cc of bile stained fluid.
(c) Once again very strangely, however, neither the records handed over to the complainant and filed by him nor those filed by the respondent include a copy of the report of this ultrasonogram of 03.10.2000 (unlike that of 02.10.2000 – part of the findings of which have been quoted in (a) above).
(d) According to the written version of the respondent, having thus diagnosed the problem as ‘biliary leak’, he ‘started the treatment of biliary leakage, which is drainage of bile’. ‘Therefore, the patient was again operated on October 4, 2000 and complete bile was sucked and to drain bile a wide bore 32 size drain was put in sub hepatic space’ (vide para. 13 (x) of the written version). Thus, what the respondent did on 04.10.2000 was a laparotomy (a major open surgery by itself) for drainage of accumulated bile/fluid (which was described as ‘minimal collection’ in the ultrasonograph of 02.10.2000), sucking out collected fluid, peritoneal lavage (toilet) and placement of a wide-bore sub-hepatic drain for continuing drainage of fluid accumulation due to leakage.
(e) The medical literature relied on by the respondent himself does not support his line of management, extracted above. For example, Bailey and Love’s Short Practice of Surgery (21st as well as 22nd Editions) – relied upon by the respondent – has the following to say on management of bile peritonitis: ‘… … … …Local drainage, and when necessary suprapubic peritoneal drainage, is imperative, and if performed early enough, these measures will save the patient’s life.’However, … If the patient is jaundiced the surgeon must ensure that the abdomen is not closed until any possible cause of obstruction to a major bile duct has been either excluded or relieved.’ Similarly, Maingot’s Abdominal Operations (also cited by the respondent) has an even more sombre injunction regarding management of bile peritonitis: ‘Management of these cases demands closure of the biliary peritoneal fistula to prevent death.’ Thus, while drainage of the fluid collection is the first part of the recommended standard practice for immediate management of bile ascites/peritonitis, the literature mandates steps to ascertain if the patient’s jaundice (as was the case here) is due to obstruction of any of the bile ducts and, if so, to relieve that obstruction (or, to close the biliary fistula – biliary fistula being ‘an abnormal passage from the gallbladder, a bile duct, or the liver to an internal organ or the surface of the body) before closing the abdomen. However, leave alone locating and closing of the biliary fistula, the ‘treatment’ given by the respondent (i.e., exploratory laparotomy for peritoneal lavage and placing a drain) did not include even an attempt to ascertain what had caused the bile accumulation in the peritoneum in the first place and, if there was any obstruction to the flow of bile through any of the major bile ducts or through a biliary fistula and if not, and what led to the jaundice.
(f) Not only recommended by all the medical literature cited above but also admitted by the respondent is the latter’s statement (vide para. 3 (xiii) of his written version and para. 7 of his affidavit evidence) regarding ERCP, “… … the treatment of biliary leakage is drainage of bile and ERCP.” and, “Thus Smt. Dogra had to be referred for ERCP.” Thus, the imperative need for an ERCP to be conducted at the earliest (in order to determine the source of bile leakage / biliary fistula or biliary obstruction before closing of the abdomen opened to drain biliary accumulation) was very much known to the respondent. In fact, he also made a very bold statement in his cross-examination, “… … … As I have deposed in para. 6 of my affidavit, the deponent diagnosed the case of Smt. Dogra of Biliary Leak. This diagnosis resulted from the perusal of the ultrasound report. The patient could be referred to PGI right at that time but I thought I was competent to treat the patient for the illness which was diagnosed by me and, therefore, I proceeded to operate her and the date of operation was fixed as 4.10.2000. … … …”
(g) According to repeated claims of the respondent, the general condition of Reeta was stable and she was ambulatory throughout her in-patient stay in his Centre. If that was so, there was no earthly reason for the respondent (who claimed to have done ‘thousands of such operations’) to defer referring Reeta for ERCP to 12.10.2000, i.e., for full 8 days since the laparotomy of 04.10.2000.
(h) After the laparotomy, a drain was placed to enable drainage of fluid collection, if any, in the peritoneum after the procedures of laparotomy + lavage.Observation of the drained fluid to see whether the fluid leakage gradually decreased and finally stopped or it showed continuous increase of both bile and blood leakage was thus mandatory. Yet, the nursing record produced by the respondent does not show any entry regarding the volume or nature of the drainage.
(i) The respondent has repeatedly stated that Reeta did not have fever after the cholecystectomy and also after the laparotomy. However, except for one entry (98.2*F) of 06.10.2000, there is no entry at all of Reeta’s temperature in the daily nursing charts from 04.10.2000, despite there being a specific column therefor in the printed forms.
(j) While still at the Centre, Reeta was transfused one unit of blood in the late evening (7.20 pm – 10 pm) of 12.10.2000 but, for some reason undisclosed, this was done at the PGI. The reasons for this transfusion were not mentioned in the written version. The blood report of 12.10.2000 on record did not include any entry of the Hb value though those of 04.10.2000 and 06.10.2000 showed Hb dropping from 9.9 to 8.5 mg/dl.
(k) Printed reports of blood picture from the Diagnostic Laboratory are available on record for the dates 04.10, 06.10 and 12.10.2000. These show serum bilirubin (SB) and serum alkaline phosphatase (SAP) values of:
04.10 SB: 7.50/6.90 (total/direct) SAP: Not recorded
06.10 9.00/7.10 SAP: 733
12.10 10.8/8.7 SAP: 2800
It was claimed that blood picture readings were also taken 09.10.2000 but (apart from hand-written entries) there is no printed report as for the other dates. The readings (that were supported by printed reports of pathology laboratory) clearly show a gradually worsening picture of the jaundice
(l) In the records produced by the respondent, there is a printed consent form for operation/procedure that was signed by Reeta, her husband and the respondent on 02.10.2000 at 3.00 pm. Though this form required that the specific name of the surgery/procedure be mentioned, the form on record left this part blank. Moreover, among the papers filed by the respondent, there is a handwritten note of the respondent that is dated 03.10.2000. Among other things, it records the needle aspiration of the Douglas Pouch and goes on to note, “Diagnosis of Biliary leakage with peritonitis established.”
- Expl. laparotomy + peritoneal lavage & ext. Biliary drainage.”
According to the respondent, even the needle aspiration of the pouch of Douglas was done in the evening of 03.10.2000, after seeing the ultrasonograph of 03.10.2000, which is not on record. Therefore, the serious question that arises is if the plan for laparotomy (or, even needle aspiration) was decided on 03.10.200, why and how the consent for the operation/procedure was obtained on 02.10.2000 and why the name/nature of the surgery/procedure was not mentioned in the consent form.
(m) The omission to advise the patient of the nature of surgery/procedure so as to enable her to understand the implications, pro and con, appears to be rather chronic because even in the consent form signed by the patient and the respondent on 11.09.2000 – i.e., for the cholecystectomy – the space marked for the details of the surgery/procedure was left completely blank!
- To summarise, the respondent/OP:
(i) in carrying out Reeta’s cholecystectomy, converted the laparoscopic procedure to open but was admittedly unable to separate the cystic duct and the cystic artery – yet he proceeded with the surgery and ligated the duct and the artery, which was not in keeping with the express opinion in the textbook of surgery (Bailey and Love’s) that he himself later submitted in support of his case;
(ii) failed to issue a proper discharge certificate after the aforesaid cholecystectomy;
(iii) failed/omitted to take due notice of Reeta’s repeated complaints of abdominal pain and advise suitable investigations till she displayed visible signs of jaundice on 02.10.2000, though even according to the respondent himself, she had mild pain throughout and severe pain on 27.09.2000;
(iv) failed to take proper and specific consent for the cholecystectomy of 11.09.2000 as well as the needle aspiration done on 03.10.2000 and for the open laparotomy done on 04.10.2000;
(v) conducted an open exploratory laparotomy on Reeta on 04.10.2000 to only drain out the accumulated bile and put an external drainage and failed/omitted to even attempt identification of the cause/source of the bile leakage, leave alone repairing/rectifying the offending opening/fistula in her biliary anatomy – that he was unable to diagnose the cause of bile leakage on 04.10.2000 is clear not only from his handwritten notes of that date but also from his undated referral note (presumably of 12/13.10.2000) to Dr. Virender Singh of the PGI in which the respondent for the first time wrote, “?Biliary leakage, ?Slipping of ligature (after 3 wks of surgery)”;
(vi) perhaps most important in the situation mentioned in sub-paragraph (v) above, referred Reeta, after a totally unexplainable delay of 8 days since the laparotomy, a period during which Reeta’s condition worsened markedly, to a private gastro-enterologist instead of the local tertiary medical care centre (PGI) for investigation and identification of the source of biliary leakage and possible treatment by means of endoscopic retrograde cholangiopancreatography (ERCP) – a procedure widely accepted as the gold standard for this purpose – though, by his own admission, he was fully aware of the need for this procedure and also that he could not have carried out that procedure himself;
(vii) to compound his several acts of omission and commission, he wrote the records of the case with material difference between the entries in one set of papers that he made over to the complainant and those in another that he subsequently filed before the State Commission; and
(viii) perhaps as a sign of guilty conscience, pleaded error of judgment in explaining (vi) above, though couched in legalese sought to be sanctified by quotations from various court decisions.
- We are aware that the medical board to which a reference had been made was also of the view that the respondent was not guilty of medical negligence but perhaps made an error of judgment. However, we are of the considered view (as demonstrated in the detailed discussion above) that the medical board did not analyse the case records closely enough nor did it clearly state if ligation of the cystic duct and the cystic artery without separating them is a standard medical practice even for an open cholecystectomy and whether it was also in keeping with standard medical protocol to do an exploratory laparotomy in such a case only for drainage of accumulated bile or the identification of the cause/source of leakage was an equally important objective.
The Legal Position
- We may now notice the law on the points relevant to this case, as laid down by the Apex Court in two of its well-known judgments:
(i)(a) In Jacob Mathew v State of Punjab [(2005) 6 SCC 1], the Court held, inter alia, vide paragraph 48-
(3) A professional may be held liable for negligence on one of the two findings: either he was not possessed of the requisite skill which he professed to have possessed, or, he did not exercise, with reasonable competence in the given case, the skill that he did possess. The standard to be applied judging whether the person charged has been negligent or not would be that of an ordinary competent person exercising ordinary skill in that profession It is not possible for every professional to possess the highest level of expertise or skills in that branch which he practices. A highly skilled professional may be possessed of better qualities, but that cannot be made the basis or the yardstick for judging the performance of the professional proceeded against on indictment of negligence.
(4) The test for determining medical negligence as laid down in Bolam case, WLR at p. 586 holds good in its applicability in India.
(b) Going back in reading the same judgment, vide para. 19, the Court observed-
“19. An oftquoted passage defining negligence by professionals, generally and not necessarily confined to doctors, is to be found in the opinion of McNair, J in Bolam v Friern Hospital Management Committee, WLR p. 586 in the following words: (ALL ER p. 121 D-F)
“[W]here you get a situation which involves the use of some special skill or competence, then the test as to whether there has been negligence or not is not the test of the man on the top of a Clapham omnibus, because he has not this special skill. … It is well-established law that it is sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular art.” (Charlesworth & Percy, ibid., para. 8.02)”
(c) Further, in para. 20, the Court cited with approval:
“20. The water of Bolam test has ever since flown and passed under several bridges, having been cited and dealt with in several judicial pronouncements, one after the other and has continued to be well-received by every shore it has touched as a neat, clean and a well-condensed one. After a review of various authorities Bingham, L.J. in his speech in Eckersley v Binnie summarised the Bolam test in the following words: (Con LR p. 79)
“From the general statements it follows that a professional man should command the corpus of knowledge which forms part of the professional equipment of the ordinary member of his profession. He should not lag behind other ordinary assiduous and intelligent members of his profession in the knowledge of new advances, discoveries and developments in his field. He should have such an awareness as an ordinarily competent practitioner would have of the deficiencies in his knowledge and the limitations on his skill. He should be alert to the hazards and risks in any professional task he undertakes to the extent that other ordinarily competent member of the profession would be alert. He must bring to any professional task he undertakes no less expertise, skill and care than ordinarily competent members of his profession would bring, but need bring no more. The standard is that of the reasonable average. The law does not require of a professional man that he be a paragon combining the qualities of polymath and prophet.”
We may notice that the “ordinary physician” contemplated here (by Bingham, L.J.) is (a) equipped with knowledge and skills of his profession/specialty, (b) assiduous, (c) intelligent and (d) abreast of the latest developments and discoveries in his field as muh as an ordinary fellow member. He is not only possessed of knowledge and other attributes mentioned above to the extent possessed by an ordinary fellow member of his profession but is also aware of the limitations of his knowledge, skills, etc., as such an ordinary member would also be. In our respectful view, this “ordinary” physician is thus not expected to be either a clodhopper or a feckless practitioner of the profession as much as he is not expected to be a “paragon combining the qualities of polymath or prophet”.
(d) As regards error of judgment in the case of a professional, the Court stated:
“25. A mere deviation from normal professional practice is not necessarily negligence. Let it be also noted that a mere accident is not evidence of negligence. So also an error of judgment on the part of a professional is not negligence per se. Higher the acuteness in emergency and higher the complication, more are the chances of error of judgment. At times, the professional is confronted with making a choice between the devil and the deep sea and he has to choose the lesser evil. The medical professional is often called upon to adopt a procedure which involves higher element of risk, but which he honestly believes as providing greater chances of success for the patient rather than a procedure involving lesser risk but higher chances of failure. Which course is more appropriate to follow would depend on the facts and circumstances of a given case. The usual practice prevalent nowadays is to obtain consent of the patient or of the person in-charge of the patient if the patient is not in a position to give consent before adopting a given procedure. So long as it can be found that the procedure which was in fact adopted was acceptable to medical science as on that date, the medical practitioner cannot be held negligent merely because he chose to follow one procedure and not another and the result was a failure.”
(ii) In respect of consent, we refer to the Apex Court’s judgment in the case of “Samira Kohli v Dr. Prabha Manchanda & Another” [(2008) 2 SCC 1]:
“49. We may now summarise the principles relating to consent as follows:
(i) A doctor has to seek and secure the consent of the patient before commencing a “treatment” (the term “treatment” includes surgery also). The consent so obtained should be real and valid, which means that: the patient should have the capacity and competence to consent; his consent should be voluntary; and his consent should be on the basis of adequate information concerning the nature of the treatment procedure, so that he knows what he is consenting to.
(ii) The ‘adequate information’ to be furnished by the doctor (or, a member of his team) who treats the patient, should enable the patient to make a balanced judgment as to whether he should submit himself to the particular treatment or not. This means that the doctor should disclose (a) nature and procedure of the treatment and its purpose, benefits and effect; (b) alternatives if any available; (c) an outline of the substantial risks; and (d) adverse consequences of refusing treatment. But there is no need to explain remote or theoretical risks involved, which may frighten or confuse a patient and result in refusal of consent for the necessary treatment. Similarly, there is no need to explain the remote or theoretical risks of refusal to take treatment which may persuade a patient to undergo a fanciful or unnecessary treatment. A balance should be achieved between the need for disclosing necessary and adequate information and at the same time avoid possibility of the patient being deterred from agreeing to a necessary treatment or offering to undergo an unnecessary treatment.
(iii) Consent given only for a diagnostic procedure cannot be considered as consent for therapeutic treatment. Consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure. The fact that the unauthorised additional surgery is beneficial to the patient, or that it would save considerable time and expense to the patient, or would relieve the patient from pain and suffering in future, are not grounds of defence in an action in tort for negligence or assault and battery. The only exception to this rule is where the additional procedure, though unauthorised, is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay such unauthorised procedure until the patient regains consciousness and takes a decision.
(iv) There can be a common consent for diagnostic and operative procedures where they are contemplated. There can also be a common consent for a particular surgical procedure and an additional or further procedure that may become necessary during the course of surgery.
(v) The nature and extent of information to be furnished by the doctor to the patient to secure the consent need not be of the stringent and high degree mentioned in Canterbury but should be of the extent which is accepted as normal and proper by a body of medical men skilled and experienced in the particular field. It will depend upon the physical and mental condition of the patient, the nature of treatment, and the risk and consequences attached to the treatment.”
- In conclusion, we are of the view that the respondent has to be held guilty of medical negligence/deficiency in service at least on four counts. The respondent did not pay any attention to the patient’s persistent complaints of pain (as he himself admitted in his referral note for ERCP) till she presented with visible signs of jaundice and thus unduly delayed the diagnostic tests that were taken only on 02.10.2000. Secondly, having conducted an “exploratory” laparotomy on 04.10.2000, he failed to even attempt locating the cause of the bile leakage suffered by the patient though all standard literature (including that cited by the respondent) pointed to cystic duct stump leak as one of the most frequent causes of such leakage – such a situation was particularly likely in this case because the cholecystectomy was proceeded with by the respondent despite his inability to clearly separate the cystic duct and the cystic artery before their dissection and ligature. Further, after conducting the laparotomy, he delayed referring the patient for ERCP for no rhyme or reason though all standard literature (and hence the corpus of knowledge and practice based thereon expected of an ordinary medical practitioner of the relevant specialty) mandated such an investigation at the earliest because that is the most widely recommended way of both diagnosing and, in some situations also treating, bile anatomy injury/obstruction evidenced by either stricture/obstruction in the biliary tree or fistular leakage of bile flow. The respondent himself knew of this, according to his repeated admissions. It is really strange that this failure could be pleaded as an error of judgment. A physician can commit an error of judgment in a case of more than one options of (or, approaches to) diagnosis and/or treatment of a patient’s condition and he honestly believing one of them to be more appropriate than the other/s for that patient, though in retrospect that may turn out to be not so appropriate or advantageous to the patient. Here, in this case, the respondnet knew full well that the patient must undergo ERCP (or, an equivalent diagnostic or diagnostic-cum-therapeutic procedure), which he was not professionally competent to conduct. Why he delayed this reference to a qualified gastro-enterologist/endoscopist, or, in this case to the PGI, when he had not even been able to identify the patient’s biliary anatomy injury, leave alone repair it, may be a ‘judgment’ of sorts of this particualr surgeon but certainly not an error of judgment that an average informed and careful surgeon would make. Finally, there is incontrovertible evidence in the form of the signed consent documents that the respondent did not discharge the duty of disclosure in case of either surgery (cholecystectomy or laparotomy) as required of him under the law governing consent. We cannot also overlook the fact that this respondent’s recording of important treatment records could be interpreted to suggest an attempt at “improving” his case but perhaps that was not deliberate. It is unfortunate that the medical board did not go into these questions with the seriousness expected of an independent body of experts. However, there is no evidence at all that the acts of the respondent /OP were the proximate cause of Reeta’s eventual death and the respondent/OP cannot be held to account for that.
- That brings us to the question of quantum of compensation. The complainant asked for Rs. 8.25 lakh (consisting of Rs. 5 lakh towards compensation for loss/damage due to medical negligence, Rs. 1.25 lakh for reimbursement of medical expenses and Rs. 2 lakh towards mental agony), with interest thereon @ 24% from the date of dispute till payment and costs of Rs. 5,000/-. In the case of “Lata Wadhwa & Others v State of Bihar & Others [(2001) 8 SCC 197], the Apex Court had taken the value of earnings of a simple housewife at Rs. 36,000/- p.m. while going into the question of compensation on account of deaths of several people that occurred in an accident in 1989. Smt. Reeta Dogra was also a simple housewife who died in 2000. Considering only the inflation since 1989, it would be reasonable to accept the sum of Rs. 10,000/- p.m. as the equivalent earning in December 2000. Applying the deduction of 1/3rd towards personal maintenance expenses, the contribution would work out to Rs. 80,000/- approx. per annum. Reeta was 46 at the time of her death and hence a multiplier of even 10 would lead to a compensation amount of Rs.8 lakh, which would have been payable in 2001 on which interest @ 9% per annum since 2001 would not be unreasonable. However, since we cannot attribute Reeta’s death solely to the acts of negligence on the part of the respondent/OP, the interest of equity would be met if his liability for compensation were restricted to Rs.7 lakh.
- As a result, the appeal is partly allowed and the order of the State Commission is set aside. The respondent is directed to pay to the appellant/complainant the sum of Rs.7 lakh as consolidated compensation, including cost, within four weeks from the date of this order, failing which the sum would be liable to be paid with interest @ 12% per annum from the date of this order till realisation.
[R. C. Jain, J]