Authors' objectives: Gallstone disease is a common gastrointestinal disorder in industrialised societies. The prevalence of gallstones in the adult population is estimated to be approximately 10–15%, and around 80% remain asymptomatic. At present, cholecystectomy is the default option for people with symptomatic gallstone disease. To assess the clinical and cost-effectiveness of observation/conservative management compared with laparoscopic cholecystectomy for preventing recurrent symptoms and complications in adults presenting with uncomplicated symptomatic gallstones in secondary care. Gallstone disease is one of the most common gastrointestinal disorders in industrialised societies. The prevalence of gallstones in the adult population is estimated to be approximately 10–15%, and around 80% remain asymptomatic. Prevalence increases with age and obesity and is higher in women than in men. At present, cholecystectomy is the default option for people with symptomatic gallstone disease. However, some people, after an initial episode of biliary pain or cholecystitis, do not experience persistent symptoms or complications. There is, therefore, an indication that uncomplicated symptomatic gallstone disease may not always require removal of the gallbladder and could be treated conservatively. To assess the clinical and cost-effectiveness of observation/conservative management compared with laparoscopic cholecystectomy for preventing recurrent symptoms and complications in adults presenting with uncomplicated symptomatic gallstones in secondary care.

Authors' results and conclusions: Between August 2016 and November 2019, 434 participants were randomised (217 in each group) from 20 United Kingdom centres. By 24 months, 64 (29.5%) in the observation/conservative management group and 153 (70.5%) in the laparoscopic cholecystectomy group had received surgery, median time to surgery of 9.0 months (interquartile range, 5.6–15.0) and 4.7 months (interquartile range 2.6–7.9), respectively. At 18 months, the mean Short Form-36 norm-based bodily pain score was 49.4 (standard deviation 11.7) in the observation/conservative management group and 50.4 (standard deviation 11.6) in the laparoscopic cholecystectomy group. The mean area under the curve over 18 months was 46.8 for both groups with no difference: mean difference –0.0, 95% confidence interval (–1.7 to 1.7); p-value 0.996; n = 203 observation/conservative, n = 205 cholecystectomy. There was no evidence of differences in quality of life, complications or need for further treatment at up to 24 months follow-up. Condition-specific quality of life at 24 months favoured cholecystectomy: mean difference 9.0, 95% confidence interval (4.1 to 14.0), p 

Authors' methods: Parallel group, multicentre patient randomised superiority pragmatic trial with up to 24 months follow-up and embedded qualitative research. Within-trial cost–utility and 10-year Markov model analyses. Development of a core outcome set for uncomplicated symptomatic gallstone disease. Secondary care elective settings. Adults with symptomatic uncomplicated gallstone disease referred to a secondary care setting were considered for inclusion. Participants were randomised 1: 1 at clinic to receive either laparoscopic cholecystectomy or observation/conservative management. The primary outcome was quality of life measured by area under the curve over 18 months using the Short Form-36 bodily pain domain. Secondary outcomes included the Otago gallstones’ condition-specific questionnaire, Short Form-36 domains (excluding bodily pain), area under the curve over 24 months for Short Form-36 bodily pain domain, persistent symptoms, complications and need for further treatment. No outcomes were blinded to allocation. Design Parallel-group, multicentre patient randomised superiority pragmatic trial with up to 24 months follow-up and embedded qualitative research. Within-trial cost–utility and 10-year Markov model analyses. Development of a core outcome set for uncomplicated symptomatic gallstone disease. Secondary care elective settings. Adults with symptomatic uncomplicated gallstone disease referred to a secondary care setting. Laparoscopic cholecystectomy. Observation/conservative management. An unexpected difficulty was the longer-than-expected time on the waiting list for surgery for those patients who were allocated to cholecystectomy. When designing the trial, it was anticipated that this wait would be, on average, 6 months. Therefore an 18-month follow-up was chosen as the primary outcome follow-up time to reflect a time equivalent to 12 months after surgery. However, during the study, we observed that patients often experienced longer times to surgery, initially due to limited existing NHS resources that resulted in longer waiting lists. To address this, we added a 24-month follow-up time point. Our sensitivity analyses on compliance with the treatment suggested that the waiting list was unlikely to be biasing the study findings. The existence of the waiting list may limit the generalisability to some other countries’ jurisdictions. A further limitation was the non-blinding of participants and treating surgeons to allocation.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/14/192/71

Year Published: 2024

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/MNBY3104

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/MNBY3104

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk