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

Not Applicable

Recruiting

• Conditions: Gallstone; Colic; Cholelithiases; Dietary Habits; Gallstone Disease; Postcholecystectomy Syndrome; Gallstone; Cholecystitis, Acute
• Interventions: Other: Fat-free diet; Other: Balanced WHO diet

• Registration Number: NCT06405906
• Lead Sponsor: University Hospital of Crete

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-27
• Status Verified: 2024-05
• Study First Submitted: 2024-05-04
• Study First Submitted QC: 2024-05-04
• Last Update Submitted: 2024-05-04
• Study First Posted: 2024-05-09
• Last Update Posted: 2024-05-09
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cholecystitis Group - Non-operative Treatment - RADIGAL1	Balanced WHO diet	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.
Cholecystitis Group - Cholecystectomy - RADIGAL2	Fat-free diet	Patients undergoing cholecystectomy due to acute cholecystitis will be randomly assigned to receive fat-free diet or balanced diet for 3 months.
Biliary Colic Group - Non-operative Treatment - RADIGAL1	Balanced WHO diet	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.
Biliary Colic Group - Non-operative Treatment - RADIGAL1	Fat-free diet	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.
Cholecystitis Group - Non-operative Treatment - RADIGAL1	Fat-free diet	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.
Biliary Colic Group - Cholecystectomy - RADIGAL2	Fat-free diet	Patients undergoing cholecystectomy due to biliary colic will be randomly assigned to receive fat-free diet or balanced diet for 3 months.
Biliary Colic Group - Cholecystectomy - RADIGAL2	Balanced WHO diet	Patients undergoing cholecystectomy due to biliary colic will be randomly assigned to receive fat-free diet or balanced diet for 3 months.
Cholecystitis Group - Cholecystectomy - RADIGAL2	Balanced WHO diet	Patients undergoing cholecystectomy due to acute cholecystitis will be randomly assigned to receive fat-free diet or balanced diet for 3 months.

Primary Outcome Measures

Name	Time	Method
Change in health-related quality of life as measured by the GIQLI score (RADIGAL1/2)	Baseline, 3-month follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Unplanned Emergency Department (ED) visit or hospital admission (RADIGAL1/2)	Baseline, 3-month follow-up	Patients will be asked about emergency department visits or hospital admissions related to the gallstone disease.
Symptom Recurrence (RADIGAL1/2)	Baseline, 3-month follow-up	Patients will be asked if they experienced postprandial abdominal pain, nausea, vomiting, or dyspepsia.
Unplanned or elective cholecystectomy (RADIGAL1)	Baseline, 3-month follow-up	Patients who treated non-operatively will be asked if they underwent unplanned or elective surgery.
Reason for discontinuing diet (RADIGAL1/2)	Baseline, 3-month follow-up	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.
Food categories chosen when not following diet (RADIGAL1/2)	Baseline, 3-month follow-up	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
Patient adherence to the suggested diet (RADIGAL1/2)	Baseline, 3-month follow-up	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.
Time of Diet Discontinuation (weeks or months) (RADIGAL1/2)	Baseline, 3-month follow-up	Patients will be asked how long after the first visit or discharge they stopped following the given diet.

Trial Locations

Locations (1)

Department of Surgery, University Hospital of Heraklion; 🇬🇷 Heraklion, Greece