Medical liability insurance claims on entry-related complications in laparoscopy

Several randomized controlled trials and meta-analyses have demonstrated that laparoscopic surgery is superior to laparotomy in terms of morbidity, postoperative recovery, and length of hospital stay. Having achieved broad acceptance, minimally invasive surgery is a fast-expanding surgical discipline.

Nevertheless, the initiation of laparoscopy, i.e., the creation of pneumoperitoneum followed by the introduction of the surgical instruments remains a potentially dangerous first step, which is exclusively associated with the laparoscopic approach.

The present study demonstrates that medical liability claims involving entry-related injuries comprised about one fifth of all laparoscopic surgery-related claims filed at MediRisk. The claims were equally distributed between general surgery and gynecologic procedures.

However, this distribution does not imply that the incidences of entry-related complications are comparable because the number of laparoscopic procedures of both specialities performed during the study period is not known.

In both the general surgery and gynecology cases the planned procedure was generally a routine one and elective in nature. Furthermore, these procedures involved mostly young female patients who planned to be operated on in a day-care setting or in short-stay surgery.

The consequences of an entry-related complication in these young patients who underwent a routine procedure is striking, however. The entry-related complication resulted in one or more laparotomies, stay in the ICU, and prolonged hospitalization.

Furthermore, 22% of the patients suffered from permanent injury. Since the first reports on entry-related complications, many articles have been published on this subject and trocars have been introduced with new design features, including retractable shields and optical trocars to allow direct viewing during insertion.

Furthermore, to avoid entry-related complications it is important to identify patients at risk, e.g., those with adhesions from previous laparotomy and obese and very thin patients. However, despite this identification, entry-related complications still occur at a constant rate.

In a recent survey of the U.S. Food and Drug Administration (FDA) Fuller et al., who reviewed all reports from January 1997 to June 2002, identified 31 fatal and 1353 nonfatal trocar injuries. Most fatalities involved vascular injuries.

In our study most claims were provoked by injuries caused by the closed-entry technique, and vascular injury was exclusively caused by the closed-entry technique.

However, this does not mean that the incidence of entry-related complications for the closed-entry technique is much higher compared with that of the openentry technique because the numbers of performed closed- and open-entry techniques are unclear.

However, retroperitoneal vascular injury is associated with ‘‘overshoot’’ of the introduction of the Veress needle or the first trocar. Theoretically, this can be avoided by using an open introduction. It is known that an open introduction might reduce the incidence of this serious complication.

On the other hand, bowel injuries are not fully avoided by the open-entry technique. Historically, gynecologists have been trained in the closed-entry technique. Although the technique of open laparoscopy was first described by the gynecologist Hasson in 1971, only a few gynecologists use the open-entry technique.

Some have reported comparable or even higher complication rates with the openentry technique in gynecologic case series. However, in these studies gynecologists did not use the open-entry technique frequently; it was used mainly in selected patients who had prior abdominal surgery.

Consequently, these patients already were at a higher risk for entry-related complications. This explains why in a systematic review by Merlin et al. the risk of major complications initially appeared to be higher for the open-entry technique.

When only prospective series were taken into account the opposite was shown, a relative risk of 0.30 (95% CI = 0.09–1.03) in favor of the open-entry technique.

It was noted that retrospective studies compared a high-risk with a low-risk patient population, while the prospective studies investigated an unselected patient population.

Furthermore, in a Japanese survey of laparoscopic surgeons, Hashizume et al. reported that during the study period 96.6% of the surgeons changed their method of establishing a pneumoperitoneum from the closed technique to the open technique to increase patient safety.

The rate of complications related to needle and/or trocar insertion subsequently decreased as the surgeons experience performing laparoscopic surgery using the open-entry technique increased. Our study also consists of a selected series of patients, because 51% of them had a history of surgery and only 46% had a normal BMI (20–25 kg/m2 ).

It is well recognized that the introduction of pneumoperitoneum and trocars in obese patients is difficult because of the lack of feeling the instruments penetrate the fascia or the insertion is too deep. However, most patients at risk are lean.

In these patients the distance between the abdominal wall and the underlying structures is short so that a Veress needle or trocar penetrating the abdominal fascia and peritoneum with a little too much force puts these structures at risk.

Furthermore, the risk of bowel injury is increased in patients who had previous abdominal surgery because of adhesions of the small bowel to the abdominal wall. Nevertheless, in the present series of patients a closed-entry technique was used despite the increased risk of complications caused by an abnormal BMI and the risk of adhesions after previous surgery.

It is remarkable that in only one third of the claims informed consent was properly given and documented, and in only 48%, were complications discussed with the patient preoperatively.

An unexpected negative outcome that is neither discussed preoperatively nor explained postoperatively is probably the most important trigger for litigation. A properly informed patient is less likely to file a claim.

This group of patients consisted of young patients who underwent routine nonadvanced surgical procedures and both surgeon and patient did not expect such a serious complication. Another factor that may have provoked litigation is that more than half of the entry-related complications were diagnosed with a delay and that several of these patients had already been discharged.

Therefore, it is important to discuss with the patient the risk of conversion to open surgery and the risk of vascular and bowel injuries in general, and to point out that not all of these injuries are diagnosed immediately.

This conversation, including the informed consent of the patient, must be documented and patients at risk (e.g., lean or obese patients or those who had previous abdominal surgery) should be identified.

Furthermore, it is important to keep in mind that entry-related complications still occur at a constant rate, even in routine procedures. This study has several limitations. First, it probably represents only a part of all entry-related complications that occur.

Furthermore, the study consists of a small, retrospectively collected, and selected population of patients, probably representing the most dramatic cases. During the study period a (growing) fraction of the hospitals in the Netherlands were insured at MediRisk.

Because of insufficient record-keeping, we were unable to clearly identify risk factors or specific trocar devices at risk. In general, this study does not present any data on the total population who had a laparoscopic procedure by the same surgeons responsible for the claims analyzed.

Therefore, the definite relationship between several factors associated with entry-related injuries could no be established. In conclusion, entry-related complications provoking litigation probably comprise one fifth of all laparoscopy-related claims.

Patients that filed a claim were mostly young females with a history of abdominal surgery who were operated on in a day-care setting or had short-stay surgery with severe consequences of the entry-related complications. Most claims involved the closed-entry technique.

Location: Indonesia