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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06405906
Other study ID # 5414/27-03-2024
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 27, 2024
Est. completion date December 1, 2025

Study information

Verified date May 2024
Source University Hospital of Crete
Contact Konstantinos Lasithiotakis, MD, PhD
Phone 00302810392677
Email k.lasithiotakis@uoc.gr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 242
Est. completion date December 1, 2025
Est. primary completion date December 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Fat-free diet
The low-fat diet will consist of instructions to avoid fatty foods.
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

Locations

Country Name City State
Greece Department of Surgery, University Hospital of Heraklion Heraklion

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Symptom Recurrence (RADIGAL1/2) Patients will be asked if they experienced postprandial abdominal pain, nausea, vomiting, or dyspepsia. Baseline, 3-month follow-up
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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