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Medico-legal problems related to cholecystectomy Vascular/hemorrhagic complications
An article for physicians by physicians
Originally published June 2010
W10-010-E

The laparoscopic approach is used for diagnosis or treatment of many abdominal pathologies. Cholecystectomy is a frequent procedure performed by general surgeons in Canada. In contrast to 20 years ago, most of these procedures are now performed by laparoscopy in an ambulatory setting.

The CMPA reviewed 131 legal cases associated with surgical complications from cholecystectomy procedures (both by laparoscopy and laparotomy) that were 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%) related to various other complications.

Vascular/hemorrhagic complications
Case study
A 30-year-old patient with previous abdominal surgery presented with symptomatic cholelithiasis. After a consent discussion, the patient opted to have a laparoscopic cholecystectomy.

Figure 1: Complications from cholecystectomy

The surgeon had been given a demonstration of a new trocar instrument in a previous setting but had not had the opportunity to use it. Without creating a pneumoperitoneum, and in a patient with a very flaccid abdominal wall, towel clips were used to hold up the abdominal wall and the instrument was inserted at an 85 to 90 degree angle. Although the surgeon thought the insertion went without incident, the patient rapidly became unstable. An open laparotomy revealed a probable aortic injury.

The patient was transferred to a larger centre where a surgical exploration confirmed a through and through injury to the aorta and damage to the renal vein. The patient suffered many complications and died four months later.

In the ensuing legal action, experts were not supportive of the surgeon, relating that whatever method of entering the abdominal wall, the abdomen musculature has to be held away from the spine and the abdominal contents as the entry is performed. It was felt that in this case, it was particularly important to do so due to the flaccidity of the abdomen wall, as a tenting effect can occur and internal organs such as the aorta can be in the immediate vicinity.

In the absence of surgical expert support, a settlement was paid to the patient’s estate by the CMPA on behalf of the member surgeon.

Review of findings for vascular/ hemorrhagic complications
Although a hemorrhagic complication can occur from the surgical dissection during a laparotomy, all of the vascular/hemorrhagic complications in this review occurred in the setting of a laparoscopic approach. There were 14 cases with this type of complication, resulting in three patient deaths. In six cases, the site of injury was at the level of a major vessel, either the aorta or the iliac vessels. In two cases, there was internal hemorrhage at the level of the abdominal wall, in two cases at the liver bed, and three cases were related to cystic artery hemorrhages. There was one case of hematoma from an injury to the mesenteric vessels.

In 10 of the 14 vascular/hemorrhagic cases, the blood vessel injury was identified during surgery. Nine of the 10 cases required an immediate conversion to laparotomy to control the bleeding; one patient’s cystic artery hemorrhage was treated using laparoscopy, but the patient’s condition subsequently deteriorated over several hours from a slow unrecognized intra-abdominal hemorrhage. The patient died before she could be taken back to the operating room. The remaining four of 14 cases of operative bleeding required a subsequent laparotomy for control of hemorrhage.

Hemorrhage during the creation of the pneumoperitoneum with the first instrument entry was identified in seven of the 14 cases: two cases using a needle instrument, four cases a trocar, and it was unclear in one case whether the use of the needle or the trocar resulted in the injury at the beginning of the surgery.

Forty-three per cent of these vascular/hemorrhagic cases resulted in a legal outcome in favour of the patient. This percentage is higher than the overall CMPA experience with legal actions.

Expert opinions
In the reviewed cases, the surgical experts stated that significant bleeding as a complication of laparoscopic surgery is rare, and usually presents in one of two different clinical patterns. The patient can become hemodynamically unstable immediately following the peritoneal access technique or during the dissection. A more subtle presentation with signs of ileus and decreasing hemoglobin over time can also occur in the first few hours post-operatively, demonstrating a “silent” hemorrhage of lesser magnitude. 

The surgical expert criticisms in the vascular/ hemorrhagic cases included the following:

• related to the technique for inserting either the trocar or the needle instrument: too deep, at a wrong angle, too many attempts at insertion, or a flaccid abdominal wall was not held away as the entry to the peritoneum was performed
• delay in converting to an open approach
• inadequate follow up of a patient’s condition in the immediate post-operative period

Risk management considerations
Based on the review of all cholecystectomy patients, closed legal files involving vascular/hemorrhagic complications, the following are suggested:

• Is the peritoneal access technique appropriate to your patient?
  
• If a bleeding complication is encountered, do you have a back-up plan to address this?
  
• Did your last inspection of the peritoneal cavity demonstrate controlled hemostasis?
  
• Do the operative note and the post-operative progress note in the medical record reflect any significant difficulties encountered in the procedure?
  
• Is an extended period of monitoring required following the procedure?
  
• Is an investigation or referral indicated to rule out potential vascular/hemorrhagic complication?

The bottom line
As with all surgical procedures, the indications and surgical approach should be reasonable, with consideration of the patient’s characteristics, the surgeon’s expertise and the support available. The informed consent discussion with the patient should outline the risks.¹  Documentation of the discussions, including alternatives to the proposed treatment, should be placed in the medical record. It is helpful if the surgeon documents in the operative note any significant difficulties encountered, and the steps taken to manage the difficulties and obtain assistance when indicated.

If signs of hemodynamic instability are present during the surgery or in the post-operative period, surgical experts emphasize the importance of having these addressed promptly by the surgical team. Consideration of additional consultation may be required.

These risk management principles apply to all laparoscopic procedures, not only to cholecystectomies.

For a discussion of the biliary tract and intestinal complications, see the articles “Medico-legal problems related to cholecystectomy—Biliary track injuries” and “Medico-legal problems related to cholecystectomy—Intestinal complications”.

1. The Canadian Medical Protective Association (CMPA). Consent: A guide for Canadian physicians, 4th edition. Ottawa (ON): The Association; 2006 May. 23 p.