Efficacy of Small Bowel Preparation in Capsule Endoscopy
NCT ID: NCT01267981
Last Updated: 2024-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
858 participants
INTERVENTIONAL
2010-09-30
2016-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Franck CHOLET, MD
Role: PRINCIPAL_INVESTIGATOR
CHRU Brest
Locations
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Centre Hospitalier d'Avignon
Avignon, , France
Cabinet privé
Béziers, , France
Centre Hospitalier d'Avicenne
Bobigny, , France
CHOLET
Brest, , France
CHRU de Lille
Lille, , 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
Hôpital Cochin
Paris, , France
Höpital Européen Geores Pompidou
Paris, , France
CH de Cornouaille Quimper
Quimper, , France
Centre Hospitalier de Saint Brieuc
Saint-Brieuc, , France
Hôpital Privé de L'Est Lyonnais
Saint-Priest, , France
CH Bretagne Atlantique
Vannes, , France
Countries
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References
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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.
Other Identifiers
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RB 09.091
Identifier Type: -
Identifier Source: org_study_id
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