Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405906
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-04
Brief Title:
A Randomized Controlled Trial Comparing Fat-free Versus Balanced WHO Diet in Gallstone Disease
Sponsor:
University Hospital of Crete
Organization:
University Hospital of Crete
Study Overview
Official Title:
Rationale Diet for Gallstone Disease RADIGAL Trial A Randomized Controlled Trial Comparing Fat-free Versus Balanced WHO Diet in Gallstone Disease
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RADIGAL
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None