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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dietary Habits; Cholelithiases; Postcholecystectomy Syndrome; Gallstone Disease; Gallstone; Colic; Gallstone; Cholecystitis, Acute
• Intervention / Treatment: Other: Fat-free diet; Other: Balanced WHO diet

• Study Type: Interventional
• Enrollment (Estimated): 242
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Konstantinos Lasithiotakis, MD, PhD; Phone Number: 00302810392677; Email: k.lasithiotakis@uoc.gr

Study Locations

• Greece
  • Heraklion, Greece, 71110
    • Recruiting
    • Department of Surgery, University Hospital of Heraklion
    • Contact: Konstantinos Lasithiotakis; Phone Number: 00302810392677; Email: k.lasithiotakis@uoc.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Fat-free diet; The low-fat diet will consist of instructions to avoid fatty foods.; 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
Experimental: 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.	Other: Fat-free diet; The low-fat diet will consist of instructions to avoid fatty foods.; 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
Experimental: 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.	Other: Fat-free diet; The low-fat diet will consist of instructions to avoid fatty foods.; 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
Experimental: 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.	Other: Fat-free diet; The low-fat diet will consist of instructions to avoid fatty foods.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in health-related quality of life as measured by the GIQLI score (RADIGAL1/2)	The GIQLI questionnaire contains 36 questions on gastrointestinal symptoms (19 items), physical status (7 items), emotional status (5 items), and social function status (5 items). Patient responses are recorded as 'all the time, most of the time, some of the time, a little of the time, or never'. The most favorable option is scored as 4 points, whereas the least favorable option receives 0 points.	Baseline, 3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient adherence to the suggested diet (RADIGAL1/2)	Patients will be queried if they followed the given diet daily, more than half the days of the month, less than half the days of the month or not at all.	Baseline, 3-month follow-up
Unplanned Emergency Department (ED) visit or hospital admission (RADIGAL1/2)	Patients will be asked about emergency department visits or hospital admissions related to the gallstone disease.	Baseline, 3-month follow-up
Symptom Recurrence (RADIGAL1/2)	Patients will be asked if they experienced postprandial abdominal pain, nausea, vomiting, or dyspepsia.	Baseline, 3-month follow-up
Unplanned or elective cholecystectomy (RADIGAL1)	Patients who treated non-operatively will be asked if they underwent unplanned or elective surgery.	Baseline, 3-month follow-up
Time of Diet Discontinuation (weeks or months) (RADIGAL1/2)	Patients will be asked how long after the first visit or discharge they stopped following the given diet.	Baseline, 3-month follow-up
Reason for discontinuing diet (RADIGAL1/2)	Patients will be asked if the reason for discontinuing the given diet is one of the following: Improvement or absence of symptoms; No improvement of symptoms; Worsening of symptoms; Personal reasons; Inability to adhere to the diet for such a long period; Hospital admission; Advice from another surgeon.	Baseline, 3-month follow-up
Food categories chosen when not following diet (RADIGAL1/2)	Patients will be asked which of the following food categories they chose to consume when they stopped following the suggested diet: Fatty and red meats; Fried and butter products; Sugar, soft drinks, sweets, and processed snacks; Fatty dairy products; High salt and cold cuts	Baseline, 3-month follow-up

Collaborators and Investigators

• Sponsor: University Hospital of Crete
• Investigators: Principal Investigator: Konstantinos Lasithiotakis, MD, PhD, Department of Surgery, University Hospital of Heraklion

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 4, 2024
• First Submitted That Met QC Criteria: May 4, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 4, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: cholecystectomy; gallstone disease; cholecystitis; gallbladder diet
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute; Gallstones; Cholelithiasis; Cholecystolithiasis; Postcholecystectomy Syndrome
• Other Study ID Numbers: 5414/27-03-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No