RESUMO
BACKGROUND: Health care providers need solid evidence based data on cost differences between alternative surgical procedures for common surgical disorders. We aimed to compare small-incision open cholecystectomy (SIOC) and laparoscopic cholecystectomy (LC) concerning costs and health-related quality of life using data from an expertise-based randomised controlled trial. METHODS: Patients scheduled for cholecystectomy were assigned to undergo LC or SIOC performed by surgeons in two different expert groups. Total costs were calculated in USD. Reusable instruments were assumed for the cost analysis. Quality of life was measured using the EuroQol 5-D 3-L (EQ 5-D-3L), at five postoperative time points and calculated to Area Under Curve (AUC) for 1 year postoperatively. Two hospitals participated in the trial, which included both emergency and elective surgery. RESULTS: Of 477 patients that underwent a cholecystectomy during the study period, 355 (74.9%) were randomised and 323 analysed, 172 LC and 151 SIOC patients. Both direct and total costs were less for SIOC than for LC patients. The total costs were 5429 (4293-6932) USD for LC and 4636 (3905-5746) USD for SIOC, P = 0.001. The quality of life index did not differ between the LC and SIOC groups at any time. Median values (25th and 75th percentiles (p25-p75)) for AUC at 1 year were as follows: 349 (337-351) for LC and 349 (338-350) for SIOC. CONCLUSIONS: In this expertise-based randomised controlled trial LC was a more costly procedure and quality of life did not differ after SIOC and LC. (ClinicalTrials.gov Identifier: NCT00370344, August 30, 2006).