Clinical trial NCT01267981: Efficacy of Small Bowel Preparation in Capsule Endoscopy
Official title: Impact of Small Bowel Preparation Using Polyethylene Glycol for Endoscopic Video-capsule (EVC)Exploration in Unexplained Gastrointestinal Bleedings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastrointestinal Bleedings
Keywords: Small bowel
video-capsule endoscopy
gastrointestinal bleeding
polyethylene glycol
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2010-12-29
Enrollment: 858
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Compare the frequencies of the diagnoses of clinically significant lesions
timeFrame: at the end of video-capsule exploration
Secondary outcomes:
measure: The quality of the preparation and visibility of the bowel
timeFrame: at the end of video-capsule exploration
measure: The clinical tolerance
timeFrame: 8 days after video-capsule exploration
measure: The number of all the observed lesions
timeFrame: at the end of video-capsule exploration
measure: Compare different times
timeFrame: at the end of video-capsule exploration
measure: Crossing (yes or no) of ileo-cecal valve by the EVC
timeFrame: At the end of video-capsule exploration
Other outcomes:
Locations:
city: Avignon
country: France
facility: Centre Hospitalier d'Avignon
city: Beziers
country: France
facility: Cabinet privé
city: Bobigny
country: France
facility: Centre Hospitalier d'Avicenne
city: Brest
country: France
facility: CHOLET
city: Lille
country: France
facility: CHRU de Lille
city: Lomme
country: France
facility: Saint Philibert Hospital
city: Lorient
country: France
facility: CH Bretagne Sud
city: Lyon
country: France
facility: Edouard Herriot Hospital
city: Marseille
country: France
facility: Hôpital de La Conception
city: Marseille
country: France
facility: Hôpital de la Timone
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Höpital Européen Geores Pompidou
city: Quimper
country: France
facility: CH de Cornouaille Quimper
city: Saint Brieuc
country: France
facility: Centre Hospitalier de Saint Brieuc
city: Saint Priest
country: France
facility: Hôpital Privé de L'Est Lyonnais
city: Vannes
country: France
facility: CH Bretagne Atlantique
Study officials:
affiliation: CHRU Brest
name: Franck CHOLET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahmi G, Cholet F, Gaudric M, Filippi J, Duburque C, Bramli S, Quentin V, Alavi Z, Nowak E, Saurin JC, Cellier C, Queneherve L; PREPINTEST working group. Effect of Different Modalities of Purgative Preparation on the Diagnostic Yield of Small Bowel Capsule for the Exploration of Suspected Small Bowel Bleeding: A Multicenter Randomized Controlled Trial. Am J Gastroenterol. 2022 Feb 1;117(2):327-335. doi: 10.14309/ajg.0000000000001597.