Efficacy of Small Bowel Preparation in Capsule Endoscopy

Phase 3

Completed

• Conditions: Gastrointestinal Bleedings
• Interventions: 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

• Registration Number: NCT01267981
• Lead Sponsor: University Hospital, Brest

Brief 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.

Detailed 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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-12-27
• Study First Submitted QC: 2010-12-28
• Study First Posted: 2010-12-29
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-11
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 858

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preparation 1	Standard diet	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.
Preparation 2	Standard Diet + 500 ml of polyethyleneglycol	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.
Preparation 3	Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycol	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.

Primary Outcome Measures

Name	Time	Method
Compare the frequencies of the diagnoses of clinically significant lesions	at the end of video-capsule exploration	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.

Secondary Outcome Measures

Name	Time	Method
The number of all the observed lesions	at the end of video-capsule exploration	Estimate the number of all the observed lesions on the recording according to their hemorrhagic potential.
The quality of the preparation and visibility of the bowel	at the end of video-capsule exploration	Demonstrate an improvement in preparation quality and bowel visibility in the various segments of small bowel examined by video-capsule endoscopy
The clinical tolerance	8 days after video-capsule exploration	Evaluate the clinical tolerance and the acceptability of the bowel preparation with oral polyethylene glycol solution
Compare different times	at the end of video-capsule exploration	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).
Crossing (yes or no) of ileo-cecal valve by the EVC	At the end of video-capsule exploration

Trial Locations

Locations (17)

Centre Hospitalier d'Avignon; 🇫🇷 Avignon, France

Saint Philibert Hospital; 🇫🇷 Lomme, France

CH Bretagne Sud; 🇫🇷 Lorient, France

Edouard Herriot Hospital; 🇫🇷 Lyon, France

Hôpital de La Conception; 🇫🇷 Marseille, France

Hôpital de la Timone; 🇫🇷 Marseille, France

Centre Hospitalier Universitaire de Nice; 🇫🇷 Nice, France

CH de Cornouaille Quimper; 🇫🇷 Quimper, France

Hôpital Cochin; 🇫🇷 Paris, France

Höpital Européen Geores Pompidou; 🇫🇷 Paris, France

Centre Hospitalier de Saint Brieuc; 🇫🇷 Saint Brieuc, France

Hôpital Privé de L'Est Lyonnais; 🇫🇷 Saint Priest, France

Centre Hospitalier d'Avicenne; 🇫🇷 Bobigny, France

Cabinet privé; 🇫🇷 Beziers, France

CHOLET; 🇫🇷 Brest, France

CHRU de Lille; 🇫🇷 Lille, France

CH Bretagne Atlantique; 🇫🇷 Vannes, France