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Randomized Controlled Trial Comparative Study
Prospective randomized trial using cost-utility analysis of early versus delayed laparoscopic cholecystectomy for acute gallbladder disease.
- D A L Macafee, D J Humes, G Bouliotis, I J Beckingham, D K Whynes, and D N Lobo.
- Division of Gastrointestinal Surgery, Nottingham Digestive Diseases Centre Biomedical Research Unit, Nottingham University Hospitals, Queen's Medical Centre, Nottingham, UK.
- Br J Surg. 2009 Sep 1; 96 (9): 1031-40.
BackgroundThis randomized controlled trial compared the cost-utility of early laparoscopic cholecystectomy with that for conventional management of newly diagnosed acute gallbladder disease.MethodsAdults 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 h 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 1 month after surgery.ResultsThe mean(s.d.) total costs of care were pound 5911(2445) for the early group and pound 6132(3244) for the conventional group (P = 0.928), Mean(s.d.) societal costs were pound 1322(1402) and pound 1461(1532) 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 pound 3810 per QALY gained.ConclusionIn 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.(c) 2009 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
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