• Annals of surgery · Aug 2022

    Randomized Controlled Trial Multicenter Study

    Cost-Effectiveness of Restrictive Strategy Versus Usual Care for Cholecystectomy in Patients With Gallstones and Abdominal Pain (SECURE-Trial).

    • Carmen S S Latenstein, Sarah Z Wennmacker, Aafke H van Dijk, DrenthJoost P HJPHDepartment of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The Netherlands., Gert P Westert, van LaarhovenCornelis J H MCJHMDepartment of Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands., Marja A Boermeester, Philip R de Reuver, DijkgraafMarcel G WMGWDepartment of Epidemiology and Data Science, Amsterdam UMC - Location AMC, Amsterdam, The Netherlands., and SECURE trial collaborators.
    • Department of Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands.
    • Ann. Surg. 2022 Aug 1; 276 (2): e93-e101.

    ObjectiveTo perform a cost-effectiveness analysis of restrictive strategy versus usual care in patients with gallstones and abdominal pain.Summary Of Background DataA restrictive selection strategy for surgery in patients with gallstones reduces cholecystectomies, but the impact on overall costs and cost-effectiveness is unknown.MethodsData of a multicentre, randomized-controlled trial (SECURE-trial) were used. Adult patients with gallstones and abdominal pain were included. Restrictive strategy was economically evaluated against usual care from a societal perspective. Hospital-use of resources was gathered with case-report forms and out-of-hospital consultations, out-of-pocket expenses, and productivity loss were collected with questionnaires. National unit costing was applied. The primary outcome was the cost per pain-free patient after 12 months.ResultsAll 1067 randomized patients (49.0 years, 73.7% females) were included. After 12 months, 56.2% of patients were pain-free in restrictive strategy versus 59.8% after usual care. The restrictive strategy significantly reduced the cholecystectomy rate with 7.7% and reduced surgical costs with €160 per patient, €162 was saved from a societal perspective. The cost-effectiveness plane showed that restrictive strategy was cost saving in 89.1%, but resulted in less pain-free patients in 88.5%. Overall, the restrictive strategy saved €4563 from a societal perspective per pain-free patient lost.ConclusionsA restrictive selection strategy for cholecystectomy saves €162 compared to usual care, but results in fewer pain-free patients. The incremental cost per pain-free patient are savings of €4563 per pain-free patient lost. The higher societal willingness to pay for 1 extra pain-free patient, the lower the probability that the restrictive strategy will be cost-effective.Trial RegistrationThe Netherlands National Trial Register NTR4022. Registered on 5 June 2013.Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.

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