PREPINTEST: Efficacy of Small Bowel Preparation in Capsule Endoscopy

Sponsor

University Hospital, Brest (Other)

Overall Status

Completed

CT.gov ID

NCT01267981

Collaborator

Ministry of Health, France (Other)

858

Enrollment

Locations

Arms

Duration (Months)

50.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Bleedings	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	Phase 3

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:

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

Study Design

Study Type:

Interventional

Actual Enrollment :

858 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Preparation 1 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 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.
Active Comparator: Preparation 2 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 Apply the standard diet and drink 500 ml of polyethylene glycol 30 minutes after the endoscopy video-capsule ingestion.
Active Comparator: Preparation 3 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 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.

Arm

Intervention/Treatment

Placebo Comparator: Preparation 1

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

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.

Active Comparator: Preparation 2

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

Apply the standard diet and drink 500 ml of polyethylene glycol 30 minutes after the endoscopy video-capsule ingestion.

Active Comparator: Preparation 3

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

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.

Outcome Measures

Primary Outcome Measures

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

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
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.
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Hospitalier d'Avignon	Avignon	France	84000
2	Cabinet privé	Beziers	France
3	Centre Hospitalier d'Avicenne	Bobigny	France	93000
4	CHOLET	Brest	France	29200
5	CHRU de Lille	Lille	France	59037
6	Saint Philibert Hospital	Lomme	France	59160
7	CH Bretagne Sud	Lorient	France	56100
8	Edouard Herriot Hospital	Lyon	France	69437
9	Hôpital de La Conception	Marseille	France	13274
10	Hôpital de la Timone	Marseille	France	13385
11	Centre Hospitalier Universitaire de Nice	Nice	France	06202
12	Hôpital Cochin	Paris	France	75014
13	Höpital Européen Geores Pompidou	Paris	France	75015
14	CH de Cornouaille Quimper	Quimper	France	29000
15	Centre Hospitalier de Saint Brieuc	Saint Brieuc	France	22000
16	Hôpital Privé de L'Est Lyonnais	Saint Priest	France	69800
17	CH Bretagne Atlantique	Vannes	France	56017