Efficacy of Small Bowel Preparation in Capsule Endoscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Inclusion Randomization Video-capsule exploration Reading of the video-capsule exam by endoscopist doctors who are in blind.

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

Conditions
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Gastrointestinal Bleedings

Intervention / Treatment
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* Drug: Standard diet
* Drug: Standard Diet + 500 ml of polyethyleneglycol
* Drug: Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 18 years old. Patients who have an indication for video-capsule endoscopy exploration for unexplained gastrointestinal bleeding associated with anaemia (man : haemoglobin <13 g/dl and woman haemoglobin <12g/dl) Less than one year Endoscopic assessment by colonoscopy and gastroscopy Not participated to an another clinic study. Written consent. Exclusion Criteria: Age<18 years old. General physical health deterioration such as dehydration or cardiac insufficiency. Clinical or radiological suspicion of digestive stenosis. Oral iron taking in the 4 days before video-capsule exploration. Functional or organic disorders of the gulp Pregnant women. Sensibility known about the polyethylene glycol. No signed consent.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Preparation 1<br>Standard diet: the day before video-capsule exploration : Drink only clears liquids after the lunch, fasting from 22 hours except usual drugs with a mouthful water. | Drug: Standard diet<br>* After the lunch the day before the exploration, drink only clear liquids and stop solid food. From 10 pm, stay fasting, don't drink except the usual drugs taken with mouthful of water until the exploration by video-capsule endoscopy.<br>|
| Active Comparator: Preparation 2<br>Standard diet : the day before video-capsule exploration : Drink only clears liquids after the lunch, fasting from 22 hours except usual drugs with a mouthful water. 500 ml of polyethylene glycol 30 minutes after the ingestion of video-capsule endoscopy. | Drug: Standard Diet + 500 ml of polyethyleneglycol<br>* Apply the standard diet and drink 500 ml of polyethylene glycol 30 minutes after the endoscopy video-capsule ingestion.<br>|
| Active Comparator: Preparation 3<br>Standard diet : the day before video-capsule exploration : Drink only clears liquids after the lunch, fasting from 22 hours except usual drugs with a mouthful water. 2 liters of polyethylene glycol between 7 pm and 9 pm. 500 ml of polyethylene glycol, 30 minutes after the ingestion of video-capsule endoscopy. | Drug: Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycol<br>* apply the standard diet and drink 2 liters of polyethylene glycol between 19h and 21h the day before exploration. Then drink 500 ml of polyethylene glycol 30 minutes after the endoscopy video-capsule ingestion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the frequencies of the diagnoses of clinically significant lesions | Compare the frequencies of the diagnoses of clinically significant lesions (P1 or P2)obtained with and without polyethylene glycol preparation for patients investigated by video-capsule endoscopy who have an unexplained digestive bleeding. | at the end of video-capsule exploration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The quality of the preparation and visibility of the bowel | Demonstrate an improvement in preparation quality and bowel visibility in the various segments of small bowel examined by video-capsule endoscopy | at the end of video-capsule exploration | 
| The clinical tolerance | Evaluate the clinical tolerance and the acceptability of the bowel preparation with oral polyethylene glycol solution | 8 days after video-capsule exploration | 
| The number of all the observed lesions | Estimate the number of all the observed lesions on the recording according to their hemorrhagic potential. | at the end of video-capsule exploration | 
| Compare different times | Compare gastric emptying time, the bowel transit time and the percentage complete medical exploration of small bowel for every group of patients (ileo- cecal valve exceeded). | at the end of video-capsule exploration | 
| Crossing (yes or no) of ileo-cecal valve by the EVC |  | At the end of video-capsule exploration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small bowel, video-capsule endoscopy, gastrointestinal bleeding, polyethylene glycol