Prospective randomized trial using cost-utility analysis of early versus delayed laparoscopic cholecystectomy for acute gallbladder disease

Background: This randomized controlled trial compared the cost-utility of early laparoscopic cholecystectomy with that for conventional management of newly diagnosed acute gallbladder disease. Methods: Adults admitted to hospital with a first episode of biliary colic or acute cholecystitis were randomized to an early intervention group (36 patients, operation within 72 It of admission) or a conventional group (36, elective cholecystectomy 3 months later). Costs were measured from a National Health Service and societal perspective. Quality-adjusted life year (QALY) gains were calculated I month after surgery. Results: The mean(s.d.) total costs of care were V,5911(2445) for the early group and 6132(3244) pound for the conventional group (P = 0.928), Mean(s.d.) societal costs were 1322(1402) pound and 1461(1532) pound for the early and conventional groups respectively (P = 0.732). Visual analogue scale scores of health were 72.94 versus 84.63 (P = 0.012) and the mean(s.d.) QALY gain was 0.85(0.26) versus 0.93(0.13) respectively (P = 0.262). The incremental cost per additional QALY gained favoured conventional management at a cost of 3810 pound per QALY gained. Conclusion: In this pragmatic trial, the cost-utilities of both the early and conventional approaches were similar, but the incremental cost per additional QALY gained favoured conventional management. Registration number: ISRCTN81663421 (http://www.controlled-trials.com).