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.

Objective: To assess the clinical and cost effectiveness of conservative management compared with laparoscopic cholecystectomy for the prevention of symptoms and complications in adults with uncomplicated symptomatic gallstone disease.
Design: Parallel group, pragmatic randomised, superiority trial.
Setting: 20 secondary care centres in the UK.
Participants: 434 adults (>18 years) with uncomplicated symptomatic gallstone disease referred to secondary care, assessed for eligibility between August 2016 and November 2019, and randomly assigned (1:1) to receive conservative management or laparoscopic cholecystectomy.
Interventions: Conservative management or surgical removal of the gallbladder.
Main Outcome Measures: The primary patient outcome was quality of life, measured by area under the curve, over 18 months using the short form 36 (SF-36) bodily pain domain, with higher scores (range 0-100) indicating better quality of life. Other outcomes included costs to the NHS, quality adjusted life years (QALYs), and incremental cost effectiveness ratio.
Results: Of 2667 patients assessed for eligibility, 434 were randomised: 217 to the conservative management group and 217 to the laparoscopic cholecystectomy group. By 18 months, 54 (25%) participants in the conservative management arm and 146 (67%) in the cholecystectomy arm had received surgery. The mean SF-36 norm based bodily pain score was 49.4 (standard deviation 11.7) in the conservative management arm and 50.4 (11.6) in the cholecystectomy arm. The SF-36 bodily pain area under the curve up to 18 months did not differ (mean difference 0.0, 95% confidence interval -1.7 to 1.7; P=1.00). Conservative management was less costly (mean difference -£1033, (-$1334; -€1205), 95% credible interval -£1413 to -£632) and QALYs did not differ (mean difference -0.019, 95% credible interval -0.06 to 0.02).
Conclusions: In the short term (≤18 months), laparoscopic surgery is no more effective than conservative management for adults with uncomplicated symptomatic gallstone disease, and as such conservative management should be considered as an alternative to surgery. From an NHS perspective, conservative management may be cost effective for uncomplicated symptomatic gallstone disease. As costs, complications, and benefits will continue to be incurred in both groups beyond 18 months, future research should focus on longer term follow-up to establish effectiveness and lifetime cost effectiveness and to identify the cohort of patients who should be routinely offered surgery.
Trial Registration: ISRCTN registry ISRCTN55215960.
Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme: KG reports being a member of the NIHR HTA Clinical Evaluation and Trials committee member since 2020; JB reports grants from NIHR Bristol Biomedical Research Centre and being a member of the NIHR Clinical Trials Unit Standing Advisory Committee 2015-19; SC is a co-investigator on unrelated grants from NIHR (HTA and Efficacy and Mechanism Evaluation: NIHR129819, 15/130/95, 15/130/20) for which her institution has received payment; BC reports a leadership or fiduciary role in the Association of Clinical Biochemistry and Laboratory medicine as president 2021-23, and Royal College of Pathologists as trustee and Scottish chair; CR reports grants from NIHR, during the conduct of the study, and member of the NIHR HTA general funding committee from 2017 to present. No other financial relationships with any organisations that might have an interest in the submitted work in the previous three years; there are no other relationships or activities that could appear to have influenced the submitted work.
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