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Objective To assess the clinical and cost effectiveness of conservative management compared with laparoscopic cholecystectomy for the prevention of symptoms and complications in adults with uncomplicated symptomatic gallstone disease.
Design Parallel group, pragmatic randomised, superiority trial.
Setting 20 secondary care centres in the UK.
Participants 434 adults (>18 years) with uncomplicated symptomatic gallstone disease referred to secondary care, assessed for eligibility between August 2016 and November 2019, and randomly assigned (1:1) to receive conservative management or laparoscopic cholecystectomy.
Interventions Conservative management or surgical removal of the gallbladder.
Main outcome measures The primary patient outcome was quality of life, measured by area under the curve, over 18 months using the short form 36 (SF-36) bodily pain domain, with higher scores (range 0-100) indicating better quality of life. Other outcomes included costs to the NHS, quality adjuste
Up to $650 in compensation available to patients who were notified in 2011 and 2012 that their records had been inappropriately accessed by employees, following lengthy class action suit.