Restrictive strategy versus usual care for cholecystectomy in patients with gallstones and abdominal pain (SECURE): a multicentre, randomised, parallel-arm, non-inferiority trial

Publication date: Available online 27 April 2019Source: The LancetAuthor(s): Aafke H van Dijk, Sarah Z Wennmacker, Philip R de Reuver, Carmen S S Latenstein, Otmar Buyne, Sandra C Donkervoort, Quirijn A J Eijsbouts, Joos Heisterkamp, Klass H in het Hof, Jan Janssen, Vincent B Nieuwenhuijs, Henk M Schaap, Pascal Steenvoorde, Hein B A C Stockmann, Djamila Boerma, Gert P Westert, Joost P H Drenth, Marcel G W Dijkgraaf, Marja A Boermeester, Cornelius J H M van LaarhovenSummaryBackgroundInternational guidelines advise laparoscopic cholecystectomy to treat symptomatic, uncomplicated gallstones. Usual care regarding cholecystectomy is associated with practice variation and persistent post-cholecystectomy pain in 10–41% of patients. We aimed to compare the non-inferiority of a restrictive strategy with stepwise selection with usual care to assess (in)efficient use of cholecystectomy.MethodsWe did a multicentre, randomised, parallel-arm, non-inferiority study in 24 academic and non-academic hospitals in the Netherlands. We enrolled patients aged 18–95 years with abdominal pain and ultrasound-proven gallstones or sludge. Patients were randomly assigned (1:1) to either usual care in which selection for cholecystectomy was left to the discretion of the surgeon, or a restrictive strategy with stepwise selection for cholecystectomy. For the restrictive strategy, cholecystectomy was advised for patients who fulfilled all five pre-specified criteria of the triage instrument: 1) severe pa...
Source: The Lancet - Category: General Medicine Source Type: research