Healthcare Issues Related to Bile Duct Injury

Abstract

Most bile duct injuries will occur in the hands of a general surgeon. The injuring surgeon should avoid the temptation to repair the bile duct injury as results of this repair are going to be poor; it is also associated with increased costs and an increased risk of litigation. The injuring surgeon should, after resuscitation and stabilization, refer the patient to a biliary center for further management. Established benign biliary stricture should be repaired by a biliary surgeon.

Also see Invited Commentary on Healthcare Issues Related to Bile Duct Injury by Philip R de Reuver (pp 209–211)

Invited Commentary on Healthcare Related Issues to Bile Duct Injury

• P. R. de Reuver 

1. Department of Gastrointestinal Surgery, Radboudumc, Nijmegen, Netherlands

   P. R. de Reuver

Bile duct injury (BDI) is a feared surgical complication of laparoscopic cholecystectomy with an estimated incidence of 0.5%. BDI is associated with increased morbidity, mortality, high rates of litigation claims, and poor long-term quality of life. In this chapter, Professor Kapoor summarizes the persistent difficulties of primary repair, adequate referral and definitive multi-disciplinary treatment in these complex cases. Despite the good functional outcome in BDI patients reported by several tertiary centres, the patient-reported outcome remains unsatisfactory. Healthcare related issues to bile duct injury in terms of quality of life, medical litigation, costs and work related limitations are a significant burden to the health care system and society.

17.1.1 Quality of Life

Quality of life assessment in BDI patients was initiated by our group as patients who had been treated for BDI reported many undefined abdominal complaints, whereas objective symptoms of recurrent jaundice or cholangitis could be demonstrated in only a few patients [13]. Patients told us they were still preoccupied with the unexpected course of events after the removal of the gall bladder. They remained disappointed by the prolonged hospital stay, the occasionally delayed diagnosis, the additional invasive interventions or even relaparotomy in the worst cases.

Data from the Academic Medical Center (AMC), Amsterdam group assessed by a survey in a large number of BDI patients showed that after a mean follow-up of 5.5 years generic quality of life (SF36) in injured patients was significantly lower in 3 of the 8 domains compared to patients who underwent cholecystectomy without an injury [14]. In 7 of the 8 QoL domains, injured patients scored significantly worse than the healthy population norms (p < 0.05). No improvement was found in a longitudinal study after 5.5 and 11 years of follow-up. Clinical characteristics such as the type of injury and type of treatment did not affect outcome. In patients who filed a malpractice claim after BDI QoL was worse. However, these patients reported better QoL if the claim was resolved in their favour compared to patients whose claim was rejected.

17.1.2 Claims

Malpractice litigation among BDI patients is common with a variation in incidence from 19% in the Dutch series up to >80% in studies from the USA [15]. Clinical factors associated with initiation of a litigation claim are young age, the severity of the injury and definitive surgical treatment. Socio-economic factors as employment during the initial cholecystectomy and postoperative use of social securities were also associated with litigation. Data analysis from the largest Dutch hospital insurer for medical liability showed that a complete transection of the common bile duct is an independent predictive factor for starting a claim procedure (OR 7.53, CI 1.85–30.63). In this Dutch series the median compensation was € 9826 (range € 1588 – € 55,301), which is in sharp contrast with the average payment in the United States. In 2006, McLean [16] reported an average payment of US$ 508,341 in 104 patients who underwent a complicated laparoscopic cholecystectomy, but compensations up to US$ 800,000 are reported [17]. Of interest is a Dutch survey which demonstrated the frail agreement among surgical experts in malpractice litigation. In one of the ten BDI cases, unanimous agreement among the experts was obtained. In the majority of cases, half of the reviewers judged that negligence had occurred while the others judged the opposite, or could not determine whether negligence of care had occurred based on the presented medical histories [18]. Therefore it was concluded that defendants, plaintiffs, experts, and lawyers should be aware of the drawbacks of expert witness testimonies.

17.1.3 Costs

The large socio-economic impact of BDI is illustrated by the significant increase in hospital costs but also costs associated with the absence from work, and the use of disability benefits. An analysis from 24 BDI patients in Sweden estimated that the overall costs for the society for the management of both mild and severe bile duct injuries would be between € 473,690 and € 608,789 annually per million inhabitants. These estimations were based on calculations on the total costs based on information on cholecystectomy, incidence, complications and costs in Scandinavia [19]. Previous studies for the United States estimated BDI related overall hospital costs ranging from US$ 100,000 to US$ 30,000, strongly depending on inclusion of costs associated with loss of work, caretaker costs, loss of eventual productivity, pain and suffering, and court claims [20].

17.1.4 Conclusion

BDI results in clinical and socio-economic long term consequences in terms of quality of life, claims and costs. Immediate honest post-operative communication to patients and relatives about diagnosis, treatment and prognosis are of great importance. The unexpected course after the cholecystectomy, the prolonged hospital stay, and the occasionally delayed diagnosis will probably remain, and form a patient’s physical and mental burden. Although an association between malpractice litigation and quality of life in BDI patients was shown in previous studies, the causality dilemma remains unanswered: what came first? Is it the poor quality of life that causes the patient to file a claim, or does the litigation process have a detrimental influence on a patient’s mental and physical wellbeing? Surgeons should be aware of the possibility of being sued after the occurrence of BDI. Honest and open communication with the patient and adequate documentation of clinical findings and therapeutical considerations might prevent a long and distressing litigation process [14, 21].