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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preparation 1 | Placebo Comparator | 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 | Active Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard diet | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franck CHOLET, MD | CHRU BREST | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier d'Avignon | Avignon | 84000 | France | |||
| Cabinet privé |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35041627 | Derived | 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. |
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| Standard Diet + 500 ml of polyethyleneglycol | Drug | 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 | Drug | 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. |
|
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 |
| Béziers |
| France |
| Centre Hospitalier d'Avicenne | Bobigny | 93000 | France |
| CHOLET | Brest | 29200 | France |
| CHRU de Lille | Lille | 59037 | France |
| Saint Philibert Hospital | Lomme | 59160 | France |
| CH Bretagne Sud | Lorient | 56100 | France |
| Edouard Herriot Hospital | Lyon | 69437 | France |
| Hôpital de La Conception | Marseille | 13274 | France |
| Hôpital de la Timone | Marseille | 13385 | France |
| Centre Hospitalier Universitaire de Nice | Nice | 06202 | France |
| Hôpital Cochin | Paris | 75014 | France |
| Höpital Européen Geores Pompidou | Paris | 75015 | France |
| CH de Cornouaille Quimper | Quimper | 29000 | France |
| Centre Hospitalier de Saint Brieuc | Saint-Brieuc | 22000 | France |
| Hôpital Privé de L'Est Lyonnais | Saint-Priest | 69800 | France |
| CH Bretagne Atlantique | Vannes | 56017 | France |
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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