C-GALL
Research type
Research Study
Full title
A randomised controlled trial comparing laparoscopic cholecystectomy with observation/conservative management for preventing recurrent symptoms and complications in adults with uncomplicated symptomatic gallstones
IRAS ID
201313
Contact name
Irfan Ahmed
Contact email
Sponsor organisation
University of Aberdeen
ISRCTN Number
ISRCTN55215960
Duration of Study in the UK
4 years, 5 months, 30 days
Research summary
Gallstones are common, especially in women, but in many people they do not cause any symptoms. About one in three people with gallstones develop symptoms. Symptoms usually include a severe pain in the upper right-hand side of the abdomen (known as ‘biliary colic’), and sometimes nausea and vomiting. At times the pain is accompanied by inflammation of the gallbladder (cholecystitis). Once gallstones start giving symptoms, painkillers, anti-inflammatory medicines and antibiotics are usually prescribed initially and surgery is advised to medically fit patients.\n\nSurgery to remove the gallbladder, known as cholecystectomy, is the most common way to treat biliary pain or cholecystitis due to gallstones. Approximately 70,000 cholecystectomies are performed every year in the UK, with significant costs for the NHS.\nIn the UK, surgery is commonly offered to people who present at secondary care with pain or cholecystitis due to gallstones. However, it is known that some patients do not have any more symptoms after the initial episode of pain and that surgery may not be necessary. A policy of ‘conservative management’ (painkillers/antibiotics and lifestyle advice) could, therefore, be appropriate in this group of people. \n\nThe C-GALL study will identify patients referred by general practitioners with symptomatic gallstone disease when they attend an NHS hospital. Patients will be recruited following informed consent and allocated randomly to either receive a surgical procedure to remove the gallbladder or to receive conservative management. Apart from treatment allocation and measurement of study outcomes, participants will have standard NHS follow up. Based on statistical calculations, we aim to recruit 430 participants across 20 UK NHS hospitals. \n\nThe main outcome of the study will be the difference between the two policies in the participants’ quality of life across an 18 month period from enrolment. Longer term benefits of either policy will predicted using a mathematical model.
REC name
North of Scotland Research Ethics Committee 2
REC reference
16/NS/0053
Date of REC Opinion
23 May 2016
REC opinion
Further Information Favourable Opinion