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

NCT ID: NCT06405906

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-27
• Study Completion Date: 2025-12-01

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 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

Gallstone Disease; Gallstone; Colic; Gallstone; Cholecystitis, Acute; Cholelithiases; Postcholecystectomy Syndrome; Dietary Habits

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Biliary Colic Group - Non-operative Treatment - RADIGAL1

Patients presenting with biliary colic and treated non-operatively will be randomly assigned to receive fat-free diet or balanced WHO diet for 3 months.

Group Type: EXPERIMENTAL

Fat-free diet

Intervention Type: OTHER

The low-fat diet will consist of instructions to avoid fatty foods.

Balanced WHO diet

Intervention Type: OTHER

The balanced WHO diet will adhere to the recommendations of the World Health Organization (WHO) and the Dietary Guidelines for Americans 2020-2025

Cholecystitis Group - Non-operative Treatment - RADIGAL1

Patients presenting with acute cholecystitis and treated non-operatively will be randomly assigned to receive fat-free diet or balanced WHO diet for 3 months.

Group Type: EXPERIMENTAL

Fat-free diet

Intervention Type: OTHER

The low-fat diet will consist of instructions to avoid fatty foods.

Balanced WHO diet

Intervention Type: OTHER

The balanced WHO diet will adhere to the recommendations of the World Health Organization (WHO) and the Dietary Guidelines for Americans 2020-2025

Biliary Colic Group - Cholecystectomy - RADIGAL2

Patients undergoing cholecystectomy due to biliary colic will be randomly assigned to receive fat-free diet or balanced diet for 3 months.

Group Type: EXPERIMENTAL

Fat-free diet

Intervention Type: OTHER

The low-fat diet will consist of instructions to avoid fatty foods.

Balanced WHO diet

Intervention Type: OTHER

The balanced WHO diet will adhere to the recommendations of the World Health Organization (WHO) and the Dietary Guidelines for Americans 2020-2025

Cholecystitis Group - Cholecystectomy - RADIGAL2

Patients undergoing cholecystectomy due to acute cholecystitis will be randomly assigned to receive fat-free diet or balanced diet for 3 months.

Group Type: EXPERIMENTAL

Fat-free diet

Intervention Type: OTHER

The low-fat diet will consist of instructions to avoid fatty foods.

Balanced WHO diet

Intervention Type: OTHER

The balanced WHO diet will adhere to the recommendations of the World Health Organization (WHO) and the Dietary Guidelines for Americans 2020-2025

Interventions

Fat-free diet

The low-fat diet will consist of instructions to avoid fatty foods.

Intervention Type: OTHER

Balanced WHO diet

The balanced WHO diet will adhere to the recommendations of the World Health Organization (WHO) and the Dietary Guidelines for Americans 2020-2025

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Crete

OTHER

Sponsor Role: lead

Responsible Party

Konstantinos Lasithiotakis

Assistant Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Konstantinos Lasithiotakis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, University Hospital of Heraklion

Locations

Department of Surgery, University Hospital of Heraklion

Heraklion, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Konstantinos Lasithiotakis, MD, PhD

Role: CONTACT

k.lasithiotakis@uoc.gr

00302810392677

Facility Contacts

Konstantinos Lasithiotakis

Role: primary

k.lasithiotakis@uoc.gr

00302810392677

Other Identifiers

5414/27-03-2024

Identifier Type: -

Identifier Source: org_study_id