Impact of Small Bowel Preparation Using Polyethylene Glycol for Endoscopic Video-capsule (EVC)Exploration in Unexplained Gastrointestinal Bleedings
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 858
- 试验地点
- 17
- 主要终点
- Compare the frequencies of the diagnoses of clinically significant lesions
研究概览
简要总结
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.
详细描述
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:
- Inclusion
- Randomization
- Video-capsule exploration
- Reading of the video-capsule exam by endoscopist doctors who are in blind.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Standard diet (Drug)
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.
干预措施: Standard Diet + 500 ml of polyethyleneglycol (Drug)
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.
干预措施: Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycol (Drug)
结局指标
主要结局
Compare the frequencies of the diagnoses of clinically significant lesions
时间窗: 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.
次要结局
- The number of all the observed lesions(at the end of video-capsule exploration)
- The quality of the preparation and visibility of the bowel(at the end of video-capsule exploration)
- The clinical tolerance(8 days after video-capsule exploration)
- Compare different times(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)