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Medico-legal problems related to cholecystectomy: Biliary tract injuries
An article for physicians by physicians
Originally published December 2009
P0904-6-E

Laparoscopic cholecystectomy is a procedure frequently performed by general surgeons in Canada. The laparoscopic approach can lead to internal complications similar to those found with the open/laparotomy approach.

The CMPA reviewed 131 legal cases associated with surgical complications from cholecystectomy procedures (both by laparoscopy and laparotomy) that closed between 2003 and 2007. The most frequent complications were biliary tract injuries (53%), intestinal injuries (19%) and vascular/hemorrhagic injuries (11%). The remaining cases (17%) involved other complications such as incisional wound infections, acute coronary syndromes, pulmonary emboli or retained foreign body material. These legal cases named the surgeons and sometimes other physicians involved in the follow-up care of the patient.

• Most complications are usually insidious in onset and can result in symptoms that are non-specific.
• Symptoms related to biliary tract or intestinal injuries can develop from hours to several days after the surgery, often when patients have returned home. Patients may then seek care from their family physician or an emergency department.
• Major vascular injury generally results in a rapid deterioration in a patient’s clinical condition at the time of operation.

Legal outcomes

In comparison with the overall CMPA experience with legal actions in the same time period, cases involving cholecystectomies resulted in fewer favourable outcomes for the physician. In the overall CMPA experience, 32 per cent of intra-abdominal non-cholecystectomy surgeries performed by general surgeons were settled in favour of the patient/plaintiff and 32 per cent of all CMPA cases were settled in favour of the patient/plaintiff; in the cholecystectomy cases reviewed, 53 per cent were settled in favour of the patient/plaintiff, as seen in Figure 1. The settlement percentages for the three main types of complications/injuries in the cholecystectomy cases varied. Settlement occurred in 70 per cent of cases with biliary tract injury, 52 per cent of cases with intestinal injury, and 36 per cent of cases with vascular/hemorrhagic injury.

Biliary tract complications

Case study

A 37-year-old female underwent laparoscopic cholecystectomy for symptomatic cholelithiasis. When bleeding difficulties were encountered, the surgeon placed multiple hemoclips, some close to the common bile duct (CBD). The patient was kept overnight in hospital because of nausea and discharged home the next day. There was no note related to the difficulties the patient encountered placed in the patient’s record during this time.

After discharge from hospital, the patient had decreased appetite, experienced abdominal pain, remained nauseated and vomited all fluid intake. On post-operative day five, she presented to the emergency department after realizing she had had dark urine for 48 hours. The emergency physician reviewed the dictated operative report available. It did not mention any significant problems at surgery. He noted jaundice and elevated liver function tests, and the patient was admitted. Endoscopic retrograde cholangio-pancreatography (ERCP) performed on the eighth post-operative day demonstrated narrowing of the CBD with a high-grade stricture at the level of the cystic duct. The patient was treated with a biliary stent for three months. The liver function tests returned to normal values.

Family or emergency physicians may see patients post-operatively with as yet undiagnosed complications of recent laparoscopic cholecystectomy.

A legal action followed. The surgical experts consulted to review the care were critical, stating that the number of hemoclips used (as identified during the ERCP study) and their application so close to the CBD indicated substandard surgical technique; they also stated the clips were likely applied without proper appreciation of the biliary anatomy. Furthermore, the operative report did not reflect the difficulties encountered during the procedure.

A settlement was paid to the patient/plaintiff by the CMPA on behalf of the member surgeon.

Review of findings for biliary tract complications

The CMPA’s review identified 70 cases of biliary tract complications (Figure 2) among the 131 cholecystectomy procedures. Six patients (9%) died as a result of the associated complications, 26 patients had a permanent disability, and 25 a major but temporary disability secondary to the complications suffered.

In six cases, the planned approach for the cholecystectomy was a formal laparotomy. Fifty-one cases were entirely laparoscopic procedures, and 13 cases began as laparoscopic procedures but were converted to an open procedure because of adhesions, bleeding or recognition that the bile duct had been lacerated or injured.

In 58 cases (83%), there was a complete ligation or transection of the CBD or hepatic duct during surgery. The remaining 17 per cent had a lesser injury to the duct leading to a bile leak, stricture or fistula. In 37 cases (53%), there was misidentification of the anatomy. The experts were critical in all these cases.

To address the 70 biliary tract injuries, corrective procedures were performed in 67 patients (96%):

• 10 solely endoscopic or percutaneous procedures
• 15 laparotomies with drainage or a repair over a T-tube, or a stent
• 41 Roux-en-Y hepaticojejunostomy procedures
• one liver transplant

It is important to note that some patients had one or more rescue procedures to address an injured bile duct before the final corrective intervention.

The remaining three of the 70 patients did not have rescue procedures performed:

• Two patients were diagnosed as having a biliary duct injury. They were transferred to a tertiary centre but died from multiple organ failure before any procedure could be contemplated.
• One patient returned to hospital nine days post-op and died following a respiratory arrest. The autopsy showed a pulmonary embolism and significant bile peritonitis.

In 70 per cent of the medico-legal cases of biliary tract injury the patient-plaintiff was paid a settlement by the CMPA on behalf of the member surgeon.

Expert opinions

The following outlines the variety of criticisms of the surgical experts who provided opinions in the cases in this review:

• lack of comprehensive informed consent discussion, including the risks of bile duct injury, intestinal injury or vascular/ hemorrhagic complications
• failure to take the necessary steps to minimize injury during the creation of the pneumoperitoneum
• failure to convert to an open approach or perform intra-operative cholangiography when unsure of the anatomy or when experiencing difficulty
• failure to identify anatomical structures adequately before the surgical clips or ligatures were applied
• operative notes failed to reflect any difficulties that were encountered during the procedure
• inappropriate delay in post-operative investigation and intervention in symptomatic patients
• incomplete discharge instructions leading to a delay in the patient seeking care

Other medical experts criticized the care provided by subsequent attending physicians for:

• deficient assessment
• delay or failure to perform appropriate investigations
• delay or failure to refer
• premature discharge from care
• inadequate discharge instructions

Risk management considerations

Based on the review of all cholecystectomy closed legal cases, CMPA members may ask themselves the following questions: For the operating surgeon:

• Have you provided a sufficient consent discussion?
• Does the operative report in the medical record reflect any significant difficulties encountered in the procedure?
• Would it be helpful to other providers to include a timely entry in the progress notes reflecting any significant difficulties encountered in the procedure?
• Have you provided the patient with discharge instructions including potential signs and symptoms of a complication, and the urgency of seeking additional care and where?

For any physician attending in the post-operative period:

• Do you have a high index of suspicion for potential complications of the surgery?
• Are investigations and/or referral indicated to rule out, for example, bile duct or intestinal injury?
• Should the attending/operating surgeon/on-call surgeon be notified of the patient’s condition?

The bottom line

• An informed consent discussion for laparoscopic cholecystectomy should not leave the patient with the impression that it is a minor procedure without the possibility of significant complications.
• Post-operative complications of cholecystectomy (by laparoscopic or open/laparotomy approach) may be non-specific initially and develop hours to several days after the surgical procedure. Appropriate discharge instructions may prompt the patient to seek early attention.
• Family or emergency physicians will often face the challenge of assessing patients with early and nonspecific symptoms of a surgical complication.