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)

M. Malik, P. Murchie, K. Gillies, M. Brazelli, A. Avenell, R. Hernandez, J. Norrie, J. Blazeby, C. Ramsay, I. Ahmed

Research output: Contribution to journalMeeting abstractpeer-review

Abstract

Aims: The aim of this multi-centre randomised trial is to compare outcomes of laparoscopic cholecystectomy with observation/conservative management over an 18 month follow-up period.
Methods: Study Design: This will be a multi-centre patient randomised superiority trial.
Study Centres: 3 centres will conduct initial pilot and 20 centres will be recruiting in the trial.
Study Period: Patients will be followed up for 18 months.
Inclusion Criteria: Adults with symptomatic uncomplicated gallstone disease who are referred to secondary care for consideration of cholecystectomy will be randomised to laparoscopic cholecystectomy or observation/ conservative management.
Exclusion Criteria: Unable to consent, ASA III and above, haemolytic disease, pregnancy, previous abdominal surgery, current or previous choledocholithiasis, acute pancreatitis, abnormal LFTs, empyema and/ or perforation of gallbladder.
Primary Outcomes: Quality of life (SF - 36), Incremental cost per QALY
Secondary Outcomes: Complications, Need for further treatment, Persistence of symptoms, Healthcare resource use.
Results: The results of the study will be published in high impact academic journals with open access to disseminate the results widely. The trial will also be presented at national and international conferences. NHS policy makers will be informed by Briefing Papers summarising key findings relevant to the NHS and Executive Summaries of main reports. Workshops will be held with key stakeholders (PPI group, surgeons, nursing staff, policy makers) to discuss the results in detail and determine strategies for the implementation of the findings into practice.
Conclusions: We anticipate that the results of this trial will provide basis to develop national and international guidelines and, ultimately, improve clinical practice.
Original languageEnglish
Pages (from-to)195-196
Number of pages2
JournalBritish Journal of Surgery
Volume103
DOIs
Publication statusPublished - 2 Aug 2016
EventInternational Surgical Congress of the Association-of-Surgeons-of-Great-Britain-and-Ireland - Belfast, Ireland
Duration: 1 Jan 2016 → …

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