Gastrointestinal Bleedings
Conditions
Keywords
Small bowel, video-capsule endoscopy, gastrointestinal bleeding, polyethylene glycol
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.
Interventions
DRUGStandard 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.
DRUGStandard Diet + 500 ml of polyethyleneglycol
Apply the standard diet and drink 500 ml of polyethylene glycol 30 minutes after the endoscopy video-capsule ingestion.
DRUGStandard 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.
Sponsors
Ministry of Health, France
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
France
Outcome results
None listed