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NCT04890210: IDEAL

Initiation of Diet in Esophageal Varices After Ligation (IDEAL) Study

Status unknown NA Last updated 18 May 2021
What this trial tests

NA trial testing Early Diet Group in Liver Cirrhosis in 130 participants. Status unknown.

Timeline
20 May 2021
Primary endpoint
1 November 2021
1 December 2021

Quick facts

Lead sponsorDr Cipto Mangunkusumo General Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment130
Start date20 May 2021
Primary completion1 November 2021
Estimated completion1 December 2021

Drugs / interventions tested

Conditions studied

Sponsor

Dr Cipto Mangunkusumo General Hospital

Who can join

18 and older, any sex, with Liver Cirrhosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

1. Objective The purpose of this study is to evaluate whether there is a significant difference of early rebleeding rate (within the first 5 days after esophageal variceal ligation), late rebleeding rate (more than 5 days until 28 days after esophageal variceal ligation), and convenience level between cirrhotic patients in early diet group versus late diet group. 2. Method This study is a single blind randomised clinical trial. Subjects will be selected based on inclusion and exclusion criteria, then the subjects will be randomly divided into 2 groups, the early diet group (clear fluid diet is initiated 1 hour after esophageal variceal ligation) and the late diet group (clear fluid diet is initiated 6 hours after esophageal variceal ligation). The intervention arm is the early diet group, while the control arm is the late diet group. The primary outcome is the early rebleeding rate. The secondary outcomes are late rebleeding rate and patient's convenience level which will be measured using Visual Analogue Scale (VAS). 3. Expected result The expected result is there will be no difference in early bleeding rate, late bleeding rate, and convenience level between early diet group versus late diet group.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Liver Cirrhosis

Currently open trials in the same condition.

Other Dr Cipto Mangunkusumo General Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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