• Sylke Haal, Maimoena S S Guman, L Maurits de Brauw, Ruben Schouten, Ruben N van Veen, Paul Fockens, GerdesVictor E AVEADepartment of Internal Medicine, Spaarne Gasthuis, Hoofddorp, the Netherlands.Departme... more nt of Internal and Vascular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, the Neth, Rogier P Voermans, and DijkgraafMarcel G WMGWDepartment of Epidemiology and Data Science, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.Amsterdam Public Health, Methodology, Amsterdam, the Netherlands.. less
• Department of Internal Medicine, Spaarne Gasthuis, Hoofddorp, the Netherlands.
• Br J Surg. 2022 Oct 14; 109 (11): 111611231116-1123.

BackgroundThe aim was to evaluate the cost-effectiveness and cost-utility of ursodeoxycholic acid (UDCA) prophylaxis for the prevention of symptomatic gallstone disease after Roux-en-Y gastric bypass (RYGB) in patients without gallstones before surgery.MethodsData from a multicentre, double-blind, randomized placebo-controlled superiority trial were used. Patients scheduled for laparoscopic RYGB or sleeve gastrectomy were randomized to receive 900 mg UDCA or placebo for 6 months. Indicated by the clinical report, prophylactic prescription of UDCA was evaluated economically against placebo from a healthcare and societal perspective for the subgroup of patients without gallstones before surgery who underwent RYGB. Volumes and costs of in-hospital care, out-of-hospital care, out-of-pocket expenses, and productivity loss were assessed. Main outcomes were the costs per patient free from symptomatic gallstone disease and the costs per quality-adjusted life-year (QALY).ResultsPatients receiving UDCA prophylaxis were more likely to remain free from symptomatic gallstone disease (relative risk 1.06, 95 per cent c.i. 1.02 to 1.11; P = 0.002) compared with patients in the placebo group. The gain in QALYs, corrected for a baseline difference in health utility, was 0.047 (95 per cent bias-corrected and accelerated (Bca) c.i. 0.007 to 0.088) higher (P = 0.022). Differences in costs were -€356 (95 per cent Bca c.i. €-1573 to 761) from a healthcare perspective and -€1392 (-3807 to 917) from a societal perspective including out-of-pocket expenses and productivity loss, both statistically non-significant, in favour of UDCA prophylaxis. The probability of UDCA prophylaxis being cost-effective was at least 0.872.ConclusionUDCA prophylaxis after RYGB in patients without gallstones before surgery was cost-effective.© The Author(s) 2022. Published by Oxford University Press on behalf of BJS Society Ltd.

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