Actively Recruiting
A Randomized Controlled Trial Comparing Fat-free Versus Balanced (WHO) Diet in Gallstone Disease
Led by University Hospital of Crete · Updated on 2024-05-09
242
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Randomized Controlled Trial Comparing Fat-free Versus Balanced (WHO) Diet in Gallstone Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- presenting with biliary colic and planned for non-operative treatment (RADIGAL1 Group 1)
- presenting with acute calculous cholecystitis and planned for non-operative management (RADIGAL1 Group 2)
- undergoing uncomplicated cholecystectomy due to biliary colic (RADIGAL2 Group 1)
- undergoing uncomplicated cholecystectomy due to acute cholecystitis (RADIGAL2 Group 2)
You will not qualify if you...
- history of gastrointestinal diseases affecting diet such as inflammatory bowel disease, irritable bowel syndrome, or short bowel syndrome
- unable to provide informed consent
- unwillingness to follow the recommended diet
- food allergies or intolerances preventing adherence to the diet
- dietary habits like vegetarianism or veganism that prevent following the diet
- gallstone-related cholangitis without biliary colic or cholecystitis
- complications from acute pancreatitis such as pseudocysts or walled-off necrosis
- choledocholithiasis (for RADIGAL2)
- complicated cholecystectomy (for RADIGAL2)
- subtotal cholecystectomy (for RADIGAL2)
- primary surgery other than cholecystectomy (for RADIGAL2)
- prior treatment with percutaneous cholecystostomy (for RADIGAL2)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Surgery, University Hospital of Heraklion
Heraklion, Greece, 71110
Actively Recruiting
Research Team
K
Konstantinos Lasithiotakis, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
4
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