Restrictive Strategy vs Usual Care for Cholecystectomy in Patients With Abdominal Pain and Gallstones
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Le résumé fourni par la source
Importance: 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. Objective: 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. Design, Setting, and Participants: 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. Interventions: Patients were randomized (1:1) to receive usual care or a restrictive strategy with stepwise selection for cholecystectomy. Main Outcomes and Measures: 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. Results: 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, -7.6%; noninferiority P = .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 (P = .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; P = .001). No differences between groups were observed in biliary and surgical complications or in patient satisfaction. Conclusions and Relevance: 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. Trial Registration: CCMO Identifier: NTR4022.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Restrictive Strategy vs Usual Care for Cholecystectomy in Patients With Abdominal Pain and Gallstones
- Date Crossref
- 01/11/2024
- Éditeur
- American Medical Association (AMA)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Radboud University Nijmegen pays non établi dans la noticeUniversité ou école supérieure
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Radboud University Medical Center pays non établi dans la noticeOrganisme public
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Flevoziekenhuis pays non établi dans la noticeÉtablissement de santé
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Maaslandziekenhuis pays non établi dans la noticeÉtablissement de santé
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OLVG pays non établi dans la noticeÉtablissement de santé
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Elisabeth-TweeSteden Ziekenhuis pays non établi dans la noticeÉtablissement de santé
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Admiraal De Ruyter Ziekenhuis pays non établi dans la noticeÉtablissement de santé
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Isala pays non établi dans la noticeÉtablissement de santé
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Medisch Spectrum Twente pays non établi dans la noticeÉtablissement de santé
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Spaarne Ziekenhuis pays non établi dans la noticeÉtablissement de santé
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Spaarne Gasthuis pays non établi dans la noticeÉtablissement de santé
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St. Antonius Ziekenhuis pays non établi dans la noticeOrganisme public
Radboud University Nijmegen, Radboud University Medical Center et Flevoziekenhuis, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.