C-Gall: A randomised controlled trial comparing the clinical effectiveness and cost-effectiveness of laparoscopic cholecystectomy compared with observation/conservative management for preventing recurrent symptoms and complications in adults with uncomplicated symptomatic gallstones
Gallstones are common but only one in three people develop symptoms (severe abdominal pain, nausea and vomiting). These are sometimes accompanied by inflammation of the gallbladder (cholecystitis). Painkillers, anti-inflammatory medicines and antibiotics are usually prescribed initially and surgery to remove the gallbladder (cholecystectomy) is advised for medically fit patients. Approximately 70,000 cholecystectomies are performed every year in the UK, with significant costs for the NHS. However, it is known that some patients do not have any more symptoms after the initial episode of pain and that surgery might not be necessary.
This study will identify, across 20 UK hospitals, 430 patients that will be randomly allocated to either receive surgery or conservative management. Participants will be followed for 18 months and the primary outcome measure will be quality of life throughout that period (measured by the area under the curve using the SF-36 instrument).
This study will include a full economic evaluation. We will also consider a model to extend the analysis beyond the clinical follow-up period. The primary economic outcome measure will be incremental cost per QALY.
Centre for Healthcare Randomised Trials (CHaRT)
National Institute for Health Research (NIHR)
HERU researchers involved in this research project: Rodolfo Hernández
External collaborators: I Ahmed (NHS Grampian); C Ramsay, J Norrie, K Gillies, A Avenell, M Brazzelli (HSRU, University of Aberdeen) and P Murchie (Other Applied Health Sciences, University of Aberdeen)