Status:
RECRUITING
A Randomized Controlled Trial Comparing Fat-free Versus Balanced (WHO) Diet in Gallstone Disease
Lead Sponsor:
University Hospital of Crete
Conditions:
Gallstone Disease
Gallstone; Colic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 undergoin...
Eligibility Criteria
Inclusion Criteria (RADIGAL1):
- 18 years old or older
- presenting with biliary colic in the ED or outpatient clinic, with the surgical team deciding to proceed with non-operative treatment (Group 1)
- presenting with acute calculous cholecystitis in the ED, with the surgical team deciding to proceed with non-operative management (Group 2)
Exclusion Criteria (RADIGAL1):
- history of gastrointestinal disease which might affect diet, e.g., inflammatory bowel disease, irritable bowel syndrome, short bowel syndrome
- inability to provide informed consent
- unwillingness to adhere to the recommended diet
- food allergies or intolerances that would prevent following the diet
- dietary habits (e.g., vegetarians, vegans) that preclude adherence to the recommended diet
- gallstone related cholangitis without biliary colic or cholecystitis
- complications from acute pancreatitis, such as pseudocysts, walled off necrosis, among others
Inclusion Criteria (RADIGAL2):
- 18 years old or older
- undergoing uncomplicated cholecystectomy (open or laparoscopic without bile duct exploration) due to a history of biliary colic (Group 1)
- undergoing uncomplicated cholecystectomy (open or laparoscopic without bile duct exploration) due to acute cholecystitis (Group 2)
Exclusion Criteria (RADIGAL2):
- history of gastrointestinal disease which might affect diet, e.g., inflammatory bowel disease, irritable bowel syndrome, short bowel syndrome
- inability to provide informed consent
- unwillingness to adhere to the recommended diet
- food allergies or intolerances that would prevent following the diet - dietary habits (e.g., vegetarians, vegans) that preclude adherence to the recommended diet
- gallstone related cholangitis without biliary colic or cholecystitis
- complications from acute pancreatitis, such as pseudocysts, walled off necrosis, among others
- choledocholithiasis
- complicated cholecystectomy
- patients undergoing subtotal cholecystectomy
- whether primary operation differs from cholecystectomy (e.g., colectomy)
- patients having treated with percutaneous cholecystostomy
Key Trial Info
Start Date :
March 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT06405906
Start Date
March 27 2024
End Date
December 1 2025
Last Update
May 9 2024
Active Locations (1)
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1
Department of Surgery, University Hospital of Heraklion
Heraklion, Greece, 71110