Gallstone disease (cholelithiasis) is one of the most common gastrointestinal disorders in industrialised societies. In the UK and North America, the number of surgical procedures for gallstone disease increased between 1950s and 1990s, reflecting both the rise in prevalence of gallstone disease and the use of cholecystectomy as the treatment of choice.
The aim of the C-GALL trial was to assess the clinical and cost effectiveness of laparoscopic cholecystectomy with observation/conservative management for preventing recurrent symptoms and complications in adults (aged 18 and over) presenting with uncomplicated symptomatic gallstones in a secondary care setting and considered suitable for cholecystectomy. The primary outcome was bodily pain (using the SF-36) up to 18 months post-randomisation. Participants completed the SF-26 at entry into the trial (baseline) and then at 3, 9, 12 and 18 months. The primary economic outcome measure was incremental cost per QALY.
The C-GALL trial recruited 434 participants from 20 UK secondary care sites: 217 were randomised to the observation/conservative management group and 217 to the laparoscopic cholecystectomy group.
By 18 months, 54 (25%) participants in the observation/conservative management group and 146 (67%) in the cholecystectomy group had received surgery. The mean SF-36 norm based bodily pain score was 49.4 (standard deviation 11.7) in the observation/conservative management group and 50.4 (11.6) in the cholecystectomy group. The SF-36 bodily pain area under the curve up to 18 months did not differ between groups (mean difference 0.0, 95% confidence interval −1.7 to 1.7; P=1.00). The results have been published in the British Medical Journal.
The C-GALL trial is led by Professor Irfan Ahmed (NHS Grampian) and Professor Craig Ramsay (University of Aberdeen) and was funded by the NIHR HTA Programme.
For more information please see the C-GALL Study Website
Contacts
- Seonaidh Cotton; s.c.cotton@abdn.ac.uk
Status
CompletedPublications
Innes K, Ahmed I, Hudson J, Hernández R, Gillies K, Bruce R, et al. Laparoscopic cholecystectomy versus conservative management for adults with uncomplicated symptomatic gallstones: the C-GALL RCT. Health Technol Assess 2024;28(26) https://doi.org/10.3310/MNBY3104
Ahmed I, Hudson J, Innes K, Hernández R, Gillies K, Bruce R et al. 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 BMJ 2023; 383 :e075383 doi:10.1136/bmj-2023-075383
Ahmed I, Innes K, Brazzelli M, et al. Protocol for a randomised controlled trial comparing laparoscopic cholecystectomy with observation/conservative management for preventing recurrent symptoms and complications in adults with uncomplicated symptomatic gallstones (C-Gall trial) BMJ Open 2021;11:e039781. doi: 10.1136/bmjopen-2020-03978