Medicolegal Issues in Laparoscopic Surgery

OVER THE PAST two decades, there have been rapid developments in medical technology, which have facilitated the ability to perform surgical operations using minimally invasive or laparoscopic (‘keyhole’) surgery. Modern laparoscopic equipment including high definition systems, provide the surgeon with an excellent view of the relevant anatomy. ‘Keyhole’ surgery has many advantages for patients in terms of a rapid recovery from surgery, less post-operative pain and better cosmetic results. Nevertheless, laparoscopic surgery is associated with specific risks and complications which are only seen in minimally invasive surgery. These may be in addition to known complications associated with traditional open surgery. Several factors influence the outcome of clinical negligence claims in relation to laparoscopic surgery.

Complications during Access to the Abdomen
The first stage common to almost all laparoscopic abdominal procedures involves gaining access to the abdominal (peritoneal) cavity and insufflating the abdomen with carbon dioxide (pneumoperitoneum). This can be achieved by use of either the Veress needle or by open cut down to insert the first port into the abdomen. Although many general surgeons now prefer the open technique, both are acceptable if performed safely and in the case of morbidly obese patients undergoing laparoscopic weight loss surgery, the use of the Veress needle is the preferred technique. A number of complications may arise during access to the abdomen so the first laparoscopic port must be inserted in a careful controlled manner. In diagnostic laparoscopy 75% of cases of alleged clinical negligence relate to bowel or vascular injuries. Damage to the small bowel may occur during placement of the first port but if this is recognized and treated correctly, a claim for negligence is unlikely to succeed. In contrast, injury to major blood vessels such as the aorta, inferior vena cava and iliac vessels usually indicates a failure of the surgeon to use adequate care when inserting the port as these structures are situated on the back of the abdomen (retroperitoneal). In this situation, major life threatening bleeding may occur and claims cannot usually be defended.

Once the first laparoscopic port has been inserted, the surgeon must ensure that they have an adequate view before inserting further ports under direct vision. For this reason, if a bowel or major vascular injury occurs during insertion of the second or subsequent ports, any claim for negligence is likely to succeed.

The Nature of the Injury
The very nature of an injury sustained during a laparoscopic procedure has a major influence on whether a claim is successful or not. One of the commonest general surgical procedures undertaken in the UK is laparoscopic cholecystectomy for the treatment of gallstones. Often now performed as a daycase, this has become the standard technique, almost completely replacing the traditional open operation. The most serious complication of laparoscopic cholecystectomy is injury to the bile duct which accounts for almost half of clinical negligence claims in relation to this procedure. Injuries vary in their severity but may have serious and life-long consequences for the patient. Major surgery is usually required to repair the injury and despite a successful repair, the patient will be at risk of complications in the future. The incidence of bile duct injuries has fallen over the past two decades, largely as a result of better training, but still occurs in approximately 0.3% of cases.

A crucial part of a laparoscopic cholecystectomy is to clearly define the biliary anatomy before dividing any structures. If the anatomy is not clear, or significant bleeding occurs which obscures the operative field, the surgeon must convert to an open operation which is necessary in up to 5% of cases. Criticism may arise where a surgeon fails to convert to an open operation as a result of which damage to major structures occurs. Bile duct injuries may not be recognised before the patient is discharged home but where an injury is recognised immediately, the surgeon must seek advice from a specialist hepatobiliary surgeon as correct surgical repair has a significant effect on long-term outcome for the patient. A bile duct injury implies that the anatomy has not been adequately displayed during the operation. This represents a breach of duty of care and any claim for negligence, is very difficult to defend.

Delay in the Management of a Recognised Complication
In other cases, it is not the nature of the complication, but how that complication is managed, which influences the outcome of a claim. Post-operative bleeding is a recognised complication of any laparoscopic operation. Bleeding may occur from the operative site such as the cystic artery in laparoscopic cholecystectomy or the appendicular artery in laparoscopic appendicectomy. Alternatively, significant bleeding may occur from the port sites on the abdominal wall. If bleeding is recognized early, the patient returned to the theatre and bleeding controlled, a claim for negligence is unlikely to succeed. If, however, there is a failure to recognise bleeding and to treat it appropriately, this may be life threatening and result in a successful claim for negligence.

In laparoscopic cholecystectomy, the second commonest reason for a medicolegal claim is a bile leak. This is a recognised complication and does not necessarily imply that the surgeon has performed a substandard operation. Indeed, if a bile leak is recognised and treated correctly, the patient should make a full recovery and a claim for negligence may not be successful. A major issue cited in many cases however, is that a delay occurs in the investigation and diagnosis of a possible bile leak which results in mismanagement of this complication. This may result in an increase in morbidity and even prove fatal. Failure to recognise and treat any recognised complication of laparoscopic surgery appropriately may represent a breach of duty of care and a clinical negligence claim under these circumstances is likely to succeed.

Experience & Subspecialty of the Operating Surgeon
All surgery, whether open or laparoscopic, must be performed by appropriately trained surgeons. Surgeons in training must be adequately supervised in a manner appropriate to their operative competency and experience. There have been several clinical negligence cases in which laparoscopic procedures have been performed by a junior doctor operating independently and unsupervised by a consultant. All trainee surgeons must be appropriately supervised until they have sufficient operative experience in a given procedure and have been assessed and deemed competent to undertake that procedure independently.

Increasing sub-specialisation within general surgery, means that consultant surgeons must also be able to demonstrate where required that they audit their own results and that they undertake laparoscopic procedures with sufficient frequency. In the case of laparoscopic cholecystectomy, it is recommended that surgeons should undertake a minimum of 40 procedures per year (NHS Institute for Innovation and Improvement 2006) which means that this operation will increasingly only be undertaken by specialist upper gastrointestinal or hepatobiliary surgeons.

The Impact of Clinical Guidelines
There are a vast number of clinical guidelines in medicine, some of which have potentially very important medico-legal implications. Acute pancreatitis is a very common acute surgical emergency which is most commonly due to gallstones. Guidelines issued by the UK Working Party on Acute Pancreatitis in 2005, established that patients diagnosed with acute gallstone pancreatitis should have definitive treatment of their gallstones within two weeks of discharge from hospital or preferably during the same hospital admission. There have now been a number of successful medico-legal claims in relation to patients discharged after an episode of acute pancreatitis, who have subsequently died from severe gallstone pancreatitis whilst on the waiting list for a cholecystectomy. Many hospitals in the UK however, struggle to meet these guidelines often due to a lack of resources and an interval of several weeks or even months may pass before a laparoscopic cholecystectomy is performed, during which time the patient is at risk of another attack of pancreatitis which could be fatal.

Negligence Due to Failure of Informed Consent
Any patient undergoing laparoscopic surgery must be consented for the possibility of conversion to open surgery. The most common complication of all laparoscopic procedures is damage to the bowel, cited in approximately one third of claims reported to the NHSLA. Although the risk is only 1 in 1000, if a bowel injury occurs the consequences are potentially very serious with the need for major surgery to rectify the problem and potential long term sequelae. Furthermore, in patients who have a history of previous abdominal surgery, the risk of bowel injury is significantly higher and this must be emphasized to the patient during consent. Similarly, in laparoscopic hernia repair, surgeons must have an adequate discussion during the consent process explaining the advantages and disadvantages of both laparoscopic and open hernia repair. The laparoscopic operation is associated with a small but definite risk of very serious complications such as major vascular or bowel injury which in some cases has resulted in death.

Conclusions
The increasing utilization of ‘keyhole’ surgery has been paralleled by a steady rise in the proportion of clinical negligence claims in relation to laparoscopic surgery. The vast majority of claims are settled out of court and expert witnesses have a vital role in this process.