Efficacy of Small Bowel Preparation in Capsule Endoscopy — PREPINTEST  

Gastrointestinal Bleedings Clinical Trial

Official title: Impact of Small Bowel Preparation Using Polyethylene Glycol for Endoscopic Video-capsule (EVC)Exploration in Unexplained Gastrointestinal Bleedings

Status Completed

Clinical Trial Summary

The best preparation of small bowel is still unknown. The primary aim of this study is to evaluate the polyethylene glycol (PEG) impact of small bowel preparation for unexplained gastrointestinal bleeding exploration. Three different preparations are evaluated in this study.

Clinical Trial Description

Now days, the endoscopic video-capsule is the more appropriate exam for unexplained gastrointestinal bleeding exploration. The responsible damage of this unexplained bleeding are frequently small vascular damages, hard to be detected in the bowel or ulcerations or tumors. The exam quality can be limited by food residues, bubbles or bile.

30% of damage are probably undetectable because of a lack of visibility. An efficient preparation will probably increased the quality of the video-capsule exploration.

The bowel exploration by endoscopy video-capsule will be realized in the usual condition. The study included 4 steps:

1. Inclusion

2. Randomization

3. Video-capsule exploration

4. Reading of the video-capsule exam by endoscopist doctors who are in blind. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Bleedings
• Gastrointestinal Hemorrhage
• Hemorrhage

• NCT number: NCT01267981
• Study type: Interventional
• Source: University Hospital, Brest
• Status: Completed
• Phase: Phase 3
• Start date: September 2010
• Completion date: January 2016