System approach to prevent common bile duct injury and enhance performance of laparoscopic cholecystectomy.

Experience collected from 5200 cases of laparoscopic cholecystectomy (LC) and 29 patients (6 ours, 23 referred) with major common bile duct (CBD) injury during LC in our institute between December 1990 and July 2004 was reported to demonstrate that the system approach we applied in performing LC prevents CBD injury and enhances surgical performance. Each case of CBD injury was meticulously analyzed to identify causative factors. We developed preventive strategies focusing on 4 dimensions: patient, environment, procedure, and operator. Surgical performance was then evaluated to demonstrate improvements. Incidence of CBD injury was calculated for early and latter halves of the series to compare 5 parameters of surgical performance: patient selection, operation time, indwelling drainage tube, surgeon, and conversion rate. Results of accident analysis demonstrated that CBD injury followed definite mechanisms; several warning signs appearing before and during injury were identified and classified. According to these results, we designed strategies to prevent injury, including: setting up patient-selection program, controlling surgical environment, developing error-proof procedures, and constructing training programs. Incidence of CBD injury in the whole series was 0.12% (6/5200), 0.27% in early half (6/2224), and zero (0/2967) in latter half. Attending doctors had significantly shorter operation times in latter period for both elective and emergent LC. Rate of using drainage tubes for elective surgery by attending doctors was significantly decreased in latter period. Operation time for elective surgery by residents was similar in both early and latter periods. However, residents in latter period had longer operation times (around 23 min long, P<0.001) for emergent LC. Steps of our system approach include: (1) detailed accident analysis focusing on patient, environment, procedure, and surgeon; (2) developing 4 strategies directly responding to accident analysis results, including proper patient selection, control of environment, error-proof procedures, and a well-designed training program; and (3) demonstrating improved patient safety and surgical performance. Consistent use of systems approach promises continuing quality improvement. We believe our working model will help perform safer LC and also benefit other medical disciplines.