Safety of care

Improving patient safety and reducing risks

Shining a light on the medical-legal risks of laparoscopic surgery

Originally published May 2017
17-11-E

Laparoscopic procedures have rapidly become the standard approach for a number of common surgical treatments. Laparoscopic surgery requires advanced surgical technique, experience with specialized equipment, and dynamic and complex clinical decision-making.1 As in other types of surgery, teamwork is also essential.

The minimally invasive nature of laparoscopic procedures offers the potential benefits of less pain and bleeding, and a faster recovery than open surgery. Yet, these procedures may also carry significant risks for patients as well as medical-legal risk for healthcare providers when things do not go as planned.

The CMPA reviewed 423 closed medical-legal cases2 involving laparoscopic procedures. Peer experts were critical of the care provided in the majority of these cases (74%). Most cases were related to an intra-operative event. Forty per cent of patients experienced severe harm or died.

The laparoscopic procedures most frequently performed were cholecystectomy, hysterectomy and other gynecological procedures (e.g. salpingo-oophorectomy), appendectomy, and nephrectomy.

Medical-legal issues by surgical phases
Pre-operative issues (29%)Intra-operative issues (82%)Post-operative issues (33%)
Note: Cases may involve issues in more than one phase of surgical care; therefore the sum of proportions exceeds 100%.
  • inadequate consent discussion
  • deficient pre-operative evaluation
  • surgical injury
  • deficient intra-operative decision-making
  • non-adherence to surgical safety protocols
    • wrong surgery
    • retained surgical items
  • delay to recognize and treat surgical complications
  • inadequate/deficient communication within team or with patient/family
  • inadequate follow-up care

Patient evaluation and informed consent

Expert criticism of the pre-operative evaluation pertained to either the lack of thorough history-taking or conducting a deficient assessment, such as not ordering the appropriate tests or not reviewing available test results before surgery. This included failing to consult with a colleague with specialized expertise when dealing with a complex case. In a few cases, experts questioned the surgeon’s choice of laparoscopy over an open approach, often related to the surgeon not taking into account the patient’s co-morbid conditions such as a history of previous abdominal surgeries.

Experts were critical of surgeons for not obtaining informed consent when the documentation in the medical record could not substantiate that the surgeon had explained the treatment options and the benefits and risks of the surgery. Experts noted that consent discussions should generally include, but are not limited to, surgical injury and the need to convert to an open approach if difficulties are encountered. In at least half the cases, the consent discussion was either poorly documented or undocumented.

Adherence to surgical safety protocols

Non-adherence to surgical safety protocols and deficient clinical decision-making were leading contributors to surgical safety incidents intra-operatively. Non-adherence to surgical safety protocols was usually related to tasks commonly incorporated in a surgical safety checklist. They included failure to:

  • perform a surgical pause (time out) to confirm the procedure with the team prior to initiating surgery
  • verify that the correct materials or equipment was available and functional prior to use
  • consider potential harm from misuse of surgical equipment

These failures were associated with wrong surgery (i.e. wrong body part, procedure, or patient), surgical injury, or burns. In 11 cases, the unintentionally retained surgical items were secondary to the failure to count items not listed on the count sheet. A few cases were related to equipment failure (e.g. endobag broke during organ retrieval).

Intra-operative decision-making and situational awareness

Experts were critical of the clinical decision-making in cases where the surgeon failed to adequately define the anatomy which later led to an injury. These injuries most often involved the common bile duct during a cholecystectomy. Experts also criticized surgeons who failed to adequately visualize and protect internal structures. In some cases, a lack of situational awareness may have contributed to deficient decision making, such as failing to recognize and react to a deteriorating situation (e.g. delay in changing a technical approach or converting to an open approach).

Case example: Difficulty determining the anatomy of the bile ducts

An older woman needs major corrective surgery to repair a common bile duct transected during laparoscopic cholecystectomy. She faces a prolonged recovery as a result.

What happened?

During the original procedure, the general surgeon encountered adhesions and fibrosis in and around the gallbladder and had difficulty with the dissection. The cystic artery was identified, clipped, and divided. He isolated what he believed to be the cystic duct, and proceeded to clip and divide it. The surgeon then dissected the gallbladder off of the liver bed and noted a bile leak from what looked like a small accessory bile duct. He clipped and divided this duct. He then removed the gallbladder and placed a drain. The patient was admitted for observation. The next day, a HIDA scan confirmed a common bile duct injury, and the patient was referred to a hepatobiliary surgeon for further management.

What did peer experts say?

Experts were critical of the surgeon’s technique but acknowledged he managed the complication adequately by leaving a drain in place and appropriately referring the patient. With respect to the injury itself, experts had the following opinions:

  • There was no documentation in the operative note that the surgeon achieved the “critical view” prior to any clipping. Experts maintained surgeons must visualize the triangle of Calot to adequately confirm the surrounding anatomy.
  • The surgeon could have done an intra-operative cholangiogram, called a colleague for a second opinion, or converted to open surgical technique to facilitate the visualization or identification of structures.

Intra-operative injuries also included laceration or damage to the bowel, vessels, ureter, reproductive organs, or nerves. Bowel and vessel injuries usually occurred during laparoscopic access with a Veress needle or trocar, but also during dissection. Intra-operative injuries were often associated with patient co-morbidities such as obesity and adhesions from previous surgeries.

Importantly, in 45% of cases where a surgical injury occurred, peer experts acknowledged that, despite good technique, the injury was a recognized risk inherent to the procedure. Experts’ opinions supported the care when there was clear documentation in the medical record that the surgeon identified and appropriately managed the injury in a timely manner, including consulting other specialists.

Case example: A bowel injury goes undetected

A woman requires repeated surgeries and a prolonged ICU stay for the management of intra-abdominal abscesses that resulted from the delayed diagnosis of a small bowel perforation from her first surgery.

What happened?

Due to dense adhesions encountered soon after beginning the laparoscopic removal of a pelvic mass, the gynecological surgeon converted to an open approach and proceeded with an apparently uneventful procedure.

On the second day of her hospital stay, the patient developed shortness of breath, tachycardia, and an elevated white blood cell count. The surgeon consulted an internist who diagnosed pneumonia and ordered antibiotics. On the third morning, the surgeon noted that the patient was progressing well. Later that day, the internist assessing the patient noted that the patient’s abdomen was distended and bowel sounds were reduced. The next day, the patient’s condition significantly deteriorated, with shortness of breath and discomfort. She was admitted to the ICU, and an abdominal and pelvic CT scan showed significant free air in the peritoneal cavity consistent with bowel perforation.

What did peer experts say?

Peer experts were of the opinion that the small bowel perforation likely occurred from the introduction of the Veress needle or the trocar during the laparoscopic phase of the surgery. They also agreed this injury is an inherent risk of surgery.

Experts theorized there was a slight delay in diagnosing the perforation because the respiratory complications diverted the surgeon’s attention from a developing abdominal complication. They noted that small bowel injuries generally take longer to detect than injuries to the colon. Nevertheless, the surgeon failed to consider that the patient's symptoms might indicate a bowel injury, and experts felt the surgeon should have assessed the patient more thoroughly and monitored her more closely and frequently.

Post-operative follow-up and early recognition of surgical injury

Some of the injuries that occurred during surgery (e.g. ureteric, bowel) remained undiagnosed until the patient became symptomatic in the post-operative period. Even then, surgeons sometimes failed to consider the possibility of a surgical injury. In some cases, experts felt the surgeon should have been more suspicious of injury, even when the surgery had been straightforward or uneventful.

Miscommunication between members of the healthcare team or with the patient and family was also identified as a problem in this phase of surgery. Deficiencies in team communication usually involved not sharing relevant information about the patient’s status and treatment decisions.

Communication problems were also found to exist with the patient and family, which included the physician’s failure to appreciate the patient’s or family’s voiced concerns, and inadequate disclosure and apology following a surgical incident. Unclear and insufficient discharge instructions sometimes affected continuity of care. For example, continuity of care was affected when discharge instructions failed to convey important information alerting patients to the possible symptoms of complications that would have prompted them to seek timely medical attention.

In some cases, the physician did not clearly document conversations that occurred during patient visits, as well as discharge instructions and telephone advice.

Strategies to provide safe surgical care during laparoscopic surgery

Based on expert opinions in the medical-legal cases, strategies to reduce surgical safety incidents related to laparoscopic surgery include the following:

For the surgical team

  • Carefully consider and communicate to the team any relevant risk factors, including comorbidities and surgical or family history that could have an impact on the patient's surgical management.
  • Implement standardized surgical safety protocols (e.g. surgical safety checklist) to ensure inter-disciplinary team situational awareness (i.e. keeping track of what is happening and anticipating what might need to be done) and improve verification practices (e.g. patient, site, procedure, and count.)
  • Consider altering technique, consulting a colleague, or promptly converting to an open procedure when difficulties are encountered.
  • Inform patients about any difficulties encountered or suspicion of a possible complication during surgery, possible post-operative complications, and alternate or emergency procedures performed during surgery.
  • Conduct a thorough examination of the patient’s fitness for discharge with consideration given to factors such as the complexity of the surgery, any difficulties encountered during or after surgery, patient age, and overall condition. Inform the patient about symptoms and signs that should alert them to seek further medical attention, and when and whom to consult in the event of complications.

For healthcare leaders

  • Facilitate and encourage maintenance of skills training (e.g. drills and simulation, peer observation, coaching) to practise dynamic decision-making, situational awareness, and effective team communication.




References

  1. Sarker SK, Chang A, Vincent C. Decision making in laparoscopic surgery. Int J Surg. 2008 Apr; 6;2:98-105.
  2. Legal, medical regulatory authority (College), and hospital cases that closed between 2011–2015

DISCLAIMER: The information contained in this learning material is for general educational purposes only and is not intended to provide specific professional medical or legal advice, nor to constitute a "standard of care" for Canadian healthcare professionals. The use of CMPA learning resources is subject to the foregoing as well as the CMPA's Terms of Use.