Evaluation of Different Bowel Preparations in Magnetically Controlled Capsule Endoscopy: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Image quality of small intestine
研究概览
简要总结
The study aimed to compare the effects of bowel preparation methods of a normal diet for 1 day, a low residue diet for 1 day, and laxative bowel cleaning on the image quality of magnetically controlled capsule endoscopy, and to assess the rate of completion of the examination, small intestine transit time, lesion detection, patient tolerance, and safety of the three regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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, male or female
- •One of the following examination indications:
- •(1) Unexplained gastrointestinal bleeding; (2) Unexplained iron deficiency anaemia; (3) Suspected Crohn's disease or monitoring and directing treatment for Crohn's disease; (4) Suspected small bowel tumour; (5) Monitoring the development of small bowel polyposis syndrome; (6) Suspected or difficult to control malabsorption syndromes (e.g., celiac disease, etc.); (7) Detection of NSAID-associated small bowel mucosal damage; (8) Those with a clinical need to exclude small bowel disease.
排除标准
- •People who are ineligible for surgery or refuse to undergo any abdominal surgery (once the capsule is retained it cannot be removed surgically);
- •Known or suspected gastrointestinal obstruction, stenosis, and fistula;
- •People with implanted cardiac pacemakers or other electronic devices;
- •People with swallowing disorders;
- •Women during pregnancy;
- •People who are unable or unwilling to provide informed consent.
研究组 & 干预措施
Laxatives arm
Normal diet 1 day before the test, fasting and laxatives from 20:00 pm. The laxatives, Polyethylene Glycol Electrolytes Powder (II), should be prepared as a solution and taken as 2000 ml the night before the test and 1000 ml the following morning, within 2 hours and 1 hour, respectively.
干预措施: Polyethylene Glycol Electrolytes Powder (II) (Drug)
Low residue diet arm
Low residue diet 1 day before the test, fasting from 20:00 pm.
干预措施: Low residue diet (Other)
Normal diet arm
Normal diet 1 day before the test, fasting from 20:00 pm.
干预措施: Normal diet (Other)
结局指标
主要结局
Image quality of small intestine
时间窗: 1 day (Upon completion of the examination)
The small bowel cleanliness score and the small bowel bubble volume score were used to evaluate image quality.
次要结局
- Rate of completion of inspections(1 day (Upon completion of the examination))
- Small intestine transit time(1 day (Upon completion of the examination))
- Patient tolerance(1 day (Upon completion of the examination))
- Rate of adverse events(1 day (Upon completion of the examination))
- Lesion detection rate(1 day (Upon completion of the examination))