{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T19:13:54Z","timestamp":1792264434540,"version":"4.4.0"},"reference-count":20,"publisher":"American Medical Association (AMA)","issue":"11","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Surg"],"published-print":{"date-parts":[[2024,11,1]]},"abstract":"\n Importance<\/jats:title>\n The 1-year results of the SECURE trial, a randomized trial comparing a restrictive strategy vs usual care for select patients with symptomatic cholelithiasis for cholecystectomy, resulted in a significantly lower operation rate after restrictive strategy. However, a restrictive strategy did not result in more pain-free patients at 1 year.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To gauge pain level and determine the proportion of pain-free patients, operation rate, and biliary and surgical complications at the 5-year follow-up.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This randomized clinical trial was a multicenter, parallel-arm, noninferiority, prospective study. Between February 2014 and April 2017, patients from 24 hospitals with symptomatic, uncomplicated cholelithiasis were included. Uncomplicated cholelithiasis was defined as gallstone disease without signs of complicated cholelithiasis, ie, biliary pancreatitis, cholangitis, common bile duct stones, or cholecystitis. Follow-up data for this analysis were collected by telephone from July 11, 2019, to September 23, 2023.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Patients were randomized (1:1) to receive usual care or a restrictive strategy with stepwise selection for cholecystectomy.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary, noninferiority end point was proportion of patients who were pain free as evaluated by Izbicki pain score at the 5-year follow-up. A 5% noninferiority margin was chosen. The secondary end points included cholecystectomy rates, biliary and surgical complications, and patient satisfaction.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Among 1067 patients, the median (IQR) age was 49.0 years (38.0-59.0 years); 786 (73.7%) were female, and 281 (26.3%) were male. At the 5-year follow-up, 228 of 363 patients (62.8%) were pain free in the usual care group, compared with 216 of 353 patients (61.2%) in restrictive strategy group (difference, 1.6%; 1-sided 95% lower confidence limit, \u22127.6%; noninferiority\n P<\/jats:italic>\n \u2009=\u2009.18). After cholecystectomy, 187 of 294 patients (63.6%) in the usual care group and 160 of 254 patients (63.0%) in the restrictive strategy group were pain free, respectively (\n P<\/jats:italic>\n \u2009=\u2009.88). The restrictive care strategy was associated with 387 of 529 cholecystectomies (73.2%) compared with 437 of 536 in the usual care group (81.5%; 8.3% difference;\n P<\/jats:italic>\n \u2009=\u2009.001). No differences between groups were observed in biliary and surgical complications or in patient satisfaction.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In the long-term, a restrictive strategy results in a significant but small reduction in operation rate compared with usual care and is not associated with increased biliary and surgical complications. However, regardless of the strategy, only two-third of patients were pain free. Further criteria for selecting patients with uncomplicated cholelithiasis for cholecystectomy and rethinking laparoscopic cholecystectomy as treatment is needed to improve patient-reported outcomes.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n CCMO Identifier:\n NTR4022<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamasurg.2024.3080","type":"journal-article","created":{"date-parts":[[2024,8,21]],"date-time":"2024-08-21T18:34:19Z","timestamp":1724265259000},"page":"1235","source":"Crossref","is-referenced-by-count":13,"title":["Restrictive Strategy vs Usual Care for Cholecystectomy in Patients With Abdominal Pain and Gallstones"],"prefix":"10.1001","volume":"159","author":[{"given":"Daan J.","family":"Comes","sequence":"first","affiliation":[{"name":"Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah Z.","family":"Wennmacker","sequence":"additional","affiliation":[{"name":"Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmen S. 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A. C.","family":"Stockmann","sequence":"additional","affiliation":[{"name":"Department of Surgery, Spaarne Gasthuis, Hoofddorp, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Djamila","family":"Boerma","sequence":"additional","affiliation":[{"name":"Department of Surgery, Antonius Ziekenhuis, Nieuwegein, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joost P. H.","family":"Drenth","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Amsterdam UMC \u2013 Location AMC, Amsterdam, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cornelis J. H. M.","family":"van Laarhoven","sequence":"additional","affiliation":[{"name":"Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marja A.","family":"Boermeester","sequence":"additional","affiliation":[{"name":"Department of Surgery, Amsterdam UMC \u2013 Location AMC, Amsterdam, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcel G. W.","family":"Dijkgraaf","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Data Science, Amsterdam UMC \u2013 Location AMC, Amsterdam, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip R.","family":"de Reuver","sequence":"additional","affiliation":[{"name":"Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","reference":[{"key":"soi240057r1","doi-asserted-by":"publisher","first-page":"16024","DOI":"10.1038\/nrdp.2016.24","article-title":"Gallstones.","volume":"2","author":"Lammert","year":"2016","journal-title":"Nat Rev Dis Primers"},{"issue":"1","key":"soi240057r2","doi-asserted-by":"publisher","first-page":"146","DOI":"10.1016\/j.jhep.2016.03.005","article-title":"EASL clinical practice guidelines on the prevention, diagnosis and treatment of gallstones.","volume":"65","author":"European Association for the Study of the Liver (EASL)","year":"2016","journal-title":"J Hepatol"},{"issue":"10","key":"soi240057r3","doi-asserted-by":"publisher","first-page":"2368","DOI":"10.1007\/s00464-010-1268-7","article-title":"SAGES guidelines for the clinical application of laparoscopic biliary tract surgery.","volume":"24","author":"Overby","year":"2010","journal-title":"Surg Endosc"},{"issue":"10188","key":"soi240057r4","doi-asserted-by":"publisher","first-page":"2322","DOI":"10.1016\/S0140-6736(19)30941-9","article-title":"Restrictive strategy versus usual care for cholecystectomy in patients with gallstones and abdominal pain (SECURE): a multicentre, randomised, parallel-arm, non-inferiority trial.","volume":"393","author":"van Dijk","year":"2019","journal-title":"Lancet"},{"key":"soi240057r5","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2023-075383","article-title":"Effectiveness of conservative management versus laparoscopic cholecystectomy in the prevention of recurrent symptoms and complications in adults with uncomplicated symptomatic gallstone disease (C-GALL trial): pragmatic, multicentre randomised controlled trial.","volume":"383","author":"Ahmed","year":"2023","journal-title":"BMJ"},{"issue":"4","key":"soi240057r6","doi-asserted-by":"publisher","first-page":"270","DOI":"10.1159\/000329464","article-title":"A randomized controlled study of uncomplicated gallstone disease with a 14-year follow-up showed that operation was the preferred treatment.","volume":"28","author":"Schmidt","year":"2011","journal-title":"Dig Surg"},{"issue":"1","key":"soi240057r7","doi-asserted-by":"publisher","first-page":"46","DOI":"10.1186\/s12893-016-0160-3","article-title":"A randomized controlled trial to compare a restrictive strategy to usual care for the effectiveness of cholecystectomy in patients with symptomatic gallstones (SECURE trial protocol).","volume":"16","author":"de Reuver","year":"2016","journal-title":"BMC Surg"},{"issue":"1","key":"soi240057r8","doi-asserted-by":"publisher","first-page":"604","DOI":"10.1186\/s13063-018-2989-5","article-title":"Statistical analysis plan of a randomized controlled trial to compare a restrictive strategy to usual care for the effectiveness of cholecystectomy (SECURE trial).","volume":"19","author":"Wennmacker","year":"2018","journal-title":"Trials"},{"issue":"4","key":"soi240057r9","doi-asserted-by":"publisher","first-page":"904","DOI":"10.1002\/hep.1840080433","article-title":"The epidemiology of gallstone disease in Rome, Italy: part I, prevalence data in men.","volume":"8","author":"The Rome Group for Epidemiology and Prevention of Cholelithiasis (GREPCO)","year":"1988","journal-title":"Hepatology"},{"issue":"4","key":"soi240057r10","doi-asserted-by":"publisher","first-page":"907","DOI":"10.1002\/hep.1840080434","article-title":"The epidemiology of gallstone disease in Rome, Italy: part II, factors associated with the disease.","volume":"8","author":"The Rome Group for Epidemiology and Prevention of Cholelithiasis (GREPCO)","year":"1988","journal-title":"Hepatology"},{"issue":"1","key":"soi240057r11","doi-asserted-by":"publisher","first-page":"70","DOI":"10.1080\/003655200750024560","article-title":"Abdominal symptoms: do they predict gallstones? 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