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).
abstract: BACKGROUND
  Five to 22 % of the adult Western population has gallstones. Among them, 13 to 22 % become symptomatic during their lifetime. Cholecystectomy is the preferred treatment for symptomatic cholecystolithiasis. Remarkably, cholecystectomy provides symptom relief in only 60-70 % of patients. The objective of this trial is to compare the effectiveness of usual (operative) care with a restrictive strategy using a standardized work-up with stepwise selection for cholecystectomy in patients with gallstones and abdominal complaints.
  
  
  METHODS
  The SECURE-trial is designed as a multicenter, randomized, parallel-arm, non-inferiority trial in patients with abdominal symptoms and ultrasound proven gallstones or sludge. If patients meet the inclusion criteria they will be randomized to either usual care or the restrictive strategy. Patients in the usual care group will be treated according to the physician's knowledge and preference. Patients in the restrictive care group will be treated with interval evaluation and stepwise selection for laparoscopic cholecystectomy. In this stepwise selection, patients strictly meeting the preselected criteria for symptomatic cholecystolithiasis will be offered a cholecystectomy. Patients not meeting these criteria will be assessed for other diagnoses and re-evaluated at 3-monthly intervals. Follow-up consists of web-based questionnaires at 3, 6, 9 and 12 months. The main end point of this trial is defined as the proportion of patients being pain-free at 12 months follow-up. Pain will be assessed with the Izbicki Pain Score and Gallstone Symptom Score. Secondary endpoints will be the proportion of patients with complications due to gallstones or cholecystectomy, the association between the patients' symptoms and treatment and work performance, and ultimately, cost-effectiveness.
  
  
  CONCLUSIONS
  The SECURE trial is the first randomized controlled trial examining the effectiveness of usual care versus restrictive care in patients with symptomatic gallstones. The outcome of this trial will inform clinicians whether a more restrictive strategy can minimize persistent pain in post-operative patients at least as good as usual care does, but at a lower cholecystectomy rate. (The Netherlands National Trial Register NTR4022, 17th December 2012) TRIAL REGISTRATION: The Netherlands National Trial Register NTR4022 http://www.zonmw.nl/nl/projecten/project-detail/scrutinizing-inefficient-use-of-cholecystectomy-a-randomized-trial-concerning-variation-in-practi/samenvatting/.
authors.affiliation: Department of Surgery, Radboud University Medical Centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands. philip.dereuver@radboudumc.nl.
authors.forename: P R
authors.initials: PR
authors.lastname: de Reuver
authors.affiliation: Department of Surgery, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
authors.forename: A H
authors.initials: AH
authors.lastname: van Dijk
authors.affiliation: Department of Surgery, Radboud University Medical Centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.
authors.forename: S Z
authors.initials: SZ
authors.lastname: Wennmacker
authors.affiliation: Department of Gastroenterology, Hepatology, Radboud University Medical Centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.
authors.forename: M P
authors.initials: MP
authors.lastname: Lamberts
authors.affiliation: Department of Surgery, St. Antonius Hospital, Koekoekslaan 1, 3435 CM, Nieuwegein, The Netherlands.
authors.forename: D
authors.initials: D
authors.lastname: Boerma
authors.affiliation: Department of Medical and Clinical Psychology, Tilburg University, P.O. Box 90153, 5000 LE, Tilburg, The Netherlands.
authors.forename: B L
authors.initials: BL
authors.lastname: den Oudsten
authors.affiliation: Clinical Research Unit, Academic Medical Centre, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
authors.forename: M G W
authors.initials: MG
authors.lastname: Dijkgraaf
authors.affiliation: Department of Surgery, Onze Lieve Vrouwe Gasthuis, Oosterpark 9, 1091 AC, Amsterdam, The Netherlands.
authors.forename: S C
authors.initials: SC
authors.lastname: Donkervoort
authors.affiliation: Department of Medical and Clinical Psychology, Tilburg University, P.O. Box 90153, 5000 LE, Tilburg, The Netherlands.|Department of Surgery, St. Elisabeth Tweesteden Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, The Netherlands.
authors.forename: J A
authors.initials: JA
authors.lastname: Roukema
authors.affiliation: Department of IQ Healthcare, Radboud University Medical Centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.
authors.forename: G P
authors.initials: GP
authors.lastname: Westert
authors.affiliation: Department of Gastroenterology, Hepatology, Radboud University Medical Centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.
authors.forename: J P H
authors.initials: JP
authors.lastname: Drenth
authors.affiliation: Department of Surgery, Radboud University Medical Centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.
authors.forename: C J H
authors.initials: CJ
authors.lastname: van Laarhoven
authors.affiliation: Department of Surgery, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
authors.forename: M A
authors.initials: MA
authors.lastname: Boermeester
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017081:Cholecystectomy, Laparoscopic; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D005260:Female; D042882:Gallstones / Q000150:complications / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D018579:Patient Selection; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
keywords: Abdominal pain; Cholecystectomy; Cost-effectiveness; Symptomatic gallstones