CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
Early refeeding group +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03306095
NCT03306095N/ACompleted

Comparison of Early Vs Delayed Feeding on Rebleeding Following Endoscopic Ligation for Acute Esophageal Variceal Bleeding

Dayanand Medical College and Hospital·observational·Posted Oct 10, 2017·Updated Jul 31, 2018

In Brief

An observational study evaluating Early refeeding group and Delayed refeeding group for Acute Gastroesophageal Variceal Bleeding. Completed, enrolled 200 participants across 1 site.

Detailed Summary

Following endoscopic therapy of variceal bleeding, the issue of when to refeed these patients has rarely been investigated. This may imply that feeding is generally regarded as a negligible factor in the management of bleeding varices. On the other hand, it is usually believed that systematic fasting is required in case of patients with upper gastrointestinal bleeding. Some researchers in their studies demonstrated that immediate refeeding has similar outcomes to delayed refeeding among patients with low risk of nonvariceal bleeding. The situation of variceal bleeding is quite different from that of peptic ulcer bleeding as demonstrated by studies of other researchers who made a review on feeding of patients with upper gastrointestinal bleeding, and recommended that feeding should be delayed for at least 48 hours after endoscopic therapy because early refeeding may cause a shift in blood flow to the splanchnic circulation, which in turn could lead to an increase in pressure and an increased risk of rebleeding from the varices. The other important reason of delay in feeding may be ascribed to the fear of occurrence of early rebleeding induced by refeeding. In addition, repeated endoscopic examination and therapy may be required in patients with very early rebleeding. The decision to delay feeding is usually based on clinicians 'experience or experts' opinion rather than evidence based. That is why we planned this study.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 10, 2017
Enrollment StartMay 2, 2017
Primary CompletionMay 1, 2018
Study CompletionJul 16, 2018
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.7 years ago

Interventions

Early refeeding groupother

Food Intake by patient with in 4 hours i.e \<4 hours after the EVL procedure

Delayed refeeding groupother

Food Intake by patient after 4 hours i.e \> 4 hours after the EVL procedure