A Randomized Controlled Trial Comparing Fat-free Versus Balanced (WHO) Diet in Gallstone Disease

Change in health-related quality of life as measured by the GIQLI score (RADIGAL1/2)

The goal of this trial is to assess the effect on the quality of life (QoL) of recommending a
 fat-free diet versus a balanced WHO diet in symptomatic patients with gallstones and in
 patients undergoing cholecystectomy for gallstone disease. The main question it aims to
 answer is:
 
 • Is balanced WHO diet as good as low-fat diet in terms of patient reported outcomes when
 gallstone disease is managed non-operatively (RADIGAL-1) or cholecystectomy is performed
 (RADIGAL-2)?
 
 A validated QoL questionnaire (Gastrointestinal Quality of Life Index - GIQLI) will be
 administered both at baseline and during follow-up. Analysis of covariance with ordinary
 least squares estimation will be applied to estimate between-group differences in GIQLI
 scores at 3 months (primary endpoint). Patient adherence and the disease-related symptoms
 occurrence or hospitalizations will also be appraised (secondary endpoint).
 
 Participants presenting with biliary colic or acute cholecystitis (RADIGAL-1) or undergoing
 cholecystectomy for gallstones (RADIGAL-2) will:
 
 - be randomly assigned to recommending either a fat-free or a balanced WHO diet .
 
 - be contacted via phone call to complete the GIQLI questionnaire and document overall
 adherence to the diets and secondary outcome events.
 
 This trial examines the impact of diet on adverse events in gallstone disease, representing
 the first randomized study to focus on this aspect.