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

Study Overview
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Brief Summary
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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. 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). 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.

Detailed Description
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This study is a single blind randomised controlled trial (RCT) that will be conducted at gastrointestinal endoscopy center division of gastroenterology, integrated procedure room division of hepatobiliary, department of internal medicine, gastroenterology clinic, hepatobiliary clinic, internal medicine ward, high care unit (HCU) and intensive care unit (ICU) Cipto Mangunkusumo Hospital - Faculty of Medicine Universitas Indonesia from May 20, 2021-November 1, 2021. The proposed number of subjects are 130 patients. Interventions will be given in the form of early clear fluid diet initiation compared to active comparator in the form of late clear fluid diet initiation in eligible liver cirrhosis patients who undergo esophageal variceal ligation (EVL) at Cipto Mangunkusumo Hospital. In early diet group diet, the 100 ml of clear fluid will be initiated at 1 hour after EVL followed by standard protocol (clear fluid, soft porridge, porridge, soft rice, regular rice) explained in the arms and intervention column below. In late diet group, the 100 ml of clear fluid will be initiated at 6 hours after EVL, followed by standard protocol (clear fluid, soft porridge, porridge, soft rice, regular rice) explained in the arms and intervention column below. Other routine and standardised drugs for liver cirrhosis patients will still be given. Statistical analysis will use Chi square test with alternative Fisher test for categorical dependent variables and independent T-test with alternative Mann-Whitney test for two group numerical dependent variables.

Official Title
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A Comparison of Clear Fluid Diet Initiation Time on Rebleeding Rate and Convenience Level in Liver Cirrhosis Patients Underwent Esophageal Variceal Ligation at Cipto Mangunkusumo Hospital

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Dietary Supplement: Early Diet Group
* Dietary Supplement: Late Diet Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Liver cirrhosis patients who underwent esophageal variceal ligation Exclusion Criteria: Hemodynamic instability (shock) Possible perforation of the esophagus Esophageal diverticula Esophageal strictures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Diet Group<br>1st diet: 100 ml of clear fluid (1 hour after esophageal variceal ligation) 2nd diet: 100 ml of clear fluid (4 hours after the 1st diet) 3rd diet: soft porridge (the amount will be calculated according to patient's caloric needs) which will be given 4 hours after the 2nd diet 4th diet: soft porridge (the amount will be calculated according to patient's caloric needs) which will be given 6 hours after the 3rd diet 5th diet: porridge (the amount will be calculated according to patient's caloric needs) which will be given 6 hours after the 4th diet 6th diet: porridge (the amount will be calculated according to patient's caloric needs) which will be given 6 hours after the 5th diet 7th diet: soft rice (the amount will be calculated according to patient's caloric needs) which will be given 6 hours after the 6th diet 8th diet: regular rice (the amount will be calculated according to patient's caloric needs) which will be given 6 hours after the 7th diet | Dietary Supplement: Early Diet Group<br>* Initiation of clear fluid diet 1 hour after esophageal variceal ligation<br>|
| Active Comparator: Late Diet Group<br>1st diet : 100 ml of clear fluid (6 hours after esophageal variceal ligation) After the 1st diet (Day 1): 6x100 ml of clear fluid for 24 hours Day 2: soft porridge (the amount will be calculated according to patient's caloric needs) for 24 hours Day 3: porridge (the amount will be calculated according to patient's caloric needs) for 24 hours Day 4: soft rice (the amount will be calculated according to patient's caloric needs) for 24 hours Day 5: regular rice (the amount will be calculated according to patient's caloric needs) for 24 hours and beyond | Dietary Supplement: Late Diet Group<br>* Initiation of clear fluid diet 6 hours after esophageal variceal ligation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early rebleeding event after esophageal variceal ligation | Early rebleeding event is hematemesis, melena and/or hematochezia that occurs within 5 days (120 hours) after esophageal variceal ligation | This outcome (early rebleeding) will be assessed within 5 days after esophageal variceal ligation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late rebleeding event after esophageal variceal ligation | Late rebleeding event is hematemesis, melena and/or hematochezia that occurs between over than 5 days until 28 days after esophageal variceal ligation | This outcome (late rebleeding) will be assessed between over than 5 days until 28 days after esophageal variceal ligation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Initiation of Diet, Esophageal Varices After Ligation, Liver cirrhosis