OBJECTIVE:To perform a cost-effectiveness analysis (CEA) of restrictive strategy versus usual care in patients with gallstones and abdominal pain. SUMMARY BACKGROUND DATA:A restrictive selection strategy for surgery in patients with gallstones reduces cholecystectomies, but the impact on overall costs and cost-effectiveness is unknown. METHODS:Data 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. RESULTS:All 1067 randomized patients (49.0 years, 73.7% females) were included. After 12 months, 56.2% of patients was 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. CONCLUSIONS:A 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 one extra pain-free patient, the lower the probability that the restrictive strategy will be cost-effective. TRIAL REGISTRATION:The Netherlands National Trial Register NTR4022. Registered on 5 June 2013.