• Sarah Z Wennmacker, Aafke H van Dijk, DrenthJoost P HJPHGastroenterology and Hepatology, Radboud University Medical Centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands., Sandra C Donkervoort, Djamila Boerma, Gert P Westert, van LaarhovenCornelis J H MCJHMDepartment of Surgery, Radboud University Medical Centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands., Marja A Boermeester, DijkgraafMarcel G WMGWClinical Research Unit, Academic Medical Centre, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands., and Philip R de Reuver.
• Department of Surgery, Radboud University Medical Centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.
• Trials. 2018 Nov 3; 19 (1): 604.

BackgroundCholecystectomy is the preferred treatment for symptomatic cholecystolithiasis. However, persistent pain after cholecystectomy for symptomatic cholecystolithiasis is reported in up to 40% of patients. The aim of the SECURE trial is to compare the effectiveness of usual care with a restrictive strategy using a standardized work-up with stepwise selection for cholecystectomy in patients with gallstones and abdominal complaints. 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. Randomization was performed to either usual care (standard practice, according to the physician's knowledge and experience, and physician's and patient's preference) or a restrictive standardized strategy: treated with interval evaluation and stepwise selection for laparoscopic cholecystectomy based on fulfilment of pre-specified criteria. This article presents in detail the statistical analysis plan (SAP) of this trial and was submitted before outcomes were available to the investigators.ResultsThe primary 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. Secondary endpoints will be the proportion of patients with complications due to gallstones or cholecystectomy, quality of life, the association between the patients' symptoms and treatment, work performance, and cost-effectiveness.DiscussionThe data from the SECURE trial will provide evidence whether or not a restrictive strategy in patients with symptomatic cholecystolithiasis is associated with similar patient reported outcomes and a reduction in the number of cholecystectomies compared to usual care. The data from this trial will be analyzed according to this pre-specified SAP.Trial RegistrationThe Netherlands National Trial Register NTR4022 . Registered on 5 June 2013.

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