Expertise-based randomized clinical trial of laparoscopic versus small-incision open cholecystectomy

Background: Several randomized clinical trials have compared laparoscopic cholecystectomy (LC) and small-incision open cholecystectomy (SIOC). Most have had wide exclusion criteria and none was expertise-based. The aim of this expertise-based randomized trial was to compare healthcare costs, quality of life (QoL), pain and clinical outcomes after LC and SIOC. Methods: Patients scheduled for cholecystectomy were randomized to treatment by one of two teams of surgeons with a preference for either LC or SIOC. Each team performed their specific method (SIOC or LC) as a first-choice operation, but converted to open cholecystectomy and common bile duct exploration when necessary. Intraoperative cholangiography was carried out routinely. The intention was to include all patients undergoing cholecystectomy, including emergency operations and procedures involving surgical training for residents. Results: Some 74.9 per cent of all patients undergoing cholecystectomy were included. Of 355 patients randomized, 333 were analysed. Self-estimated QoL scores in 258 patients, analysed by the area under the curve method, were significantly lower in the SIOC group at 1 month after surgery: median 2326 (95 per cent confidence interval 2187 to 2391) compared with 2411 (2334 to 2502) for the LC group (P = 0.030). The mean(s.d.) duration of operation was shorter for SIOC: 97(41) versus 120(48) min (P < 0.001). There were no significant differences between the groups in conversion rate, pain, complications, length of hospital stay or readmissions. Conclusion: SIOC had comparable surgical results but slightly worse short-term QoL compared with LC. Registration number: NCT00370344 (http://www.clinicaltrials.gov).