A Phase 3 interventional study of Standard diet and Standard Diet + 500 ml of polyethyleneglycol in Gastrointestinal Bleedings, sponsored by University Hospital, Brest. Completed at 17 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by University Hospital, Brest · Phase 3, Interventional, and Treatment
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:
339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.
This study's enrollment of 858 is above the median of 87 across 211 interventional studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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.
Apply the standard diet and drink 500 ml of polyethylene glycol 30 minutes after the endoscopy video-capsule ingestion.
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.
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.
Time frame: at the end of video-capsule exploration
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
Time frame: at the end of video-capsule exploration
The clinical tolerance
Evaluate the clinical tolerance and the acceptability of the bowel preparation with oral polyethylene glycol solution
Time frame: 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.
Time frame: 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).
Time frame: at the end of video-capsule exploration
Crossing (yes or no) of ileo-cecal valve by the EVC
Time frame: At the end of video-capsule exploration
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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University Hospital, Brest