Double-balloon Colonoscopy to Increase Cecal Intubation Rate in Technically Difficult Colonoscopies
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Cecal intubation rate
研究概览
简要总结
The aim of colonoscopy is to visualize the inside of the entire large bowel. Several factors can make the procedure difficult, and sometimes a complete examination is not possible. Complicating factors include poor bowel preparation and technical challenges such as differences in anatomy (long, redundant colonic segments), post-surgical adhesions, strictures and diverticulosis. A special endoscope with two inflatable balloons, originally designed to examine the small bowel, has been used for several years with success in such technically difficult colonoscopies. More recently a modified double-balloon instrument was designed specifically for colonoscopy, but the documentation of the performance of this instrument is limited. The aim of the present study is to investigate the performance of the double-balloon colonoscope in cases where conventional colonoscopy have failed due to technical difficulties.
详细描述
This is a prospective cohort study to investigate the performance of the test instrument. The test instrument consists of a slim, flexible colonoscope with an overtube and an inflatable balloon on the tip of the colonoscope and the tip of the overtube. Patients are eligible for inclusion if conventional colonoscopy fails due to technical difficulties such as loop formation, long colonic segments or suspected adhesions. Written informed consent is required. The study procedures will be performed immediately after the failed conventional colonoscopy, or on a rescheduled appointment within four weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Failed cecal intubation during conventional colonoscopy due to technical difficulties
排除标准
- •Failed cecal intubation due to insufficient bowel preparation
- •Stenotic colonic lesions
- •Patients decline
- •Pregnancy
- •Persons younger than 18 years
- •Persons unable to comprehend the information given
结局指标
主要结局
Cecal intubation rate
时间窗: 2 hours
The primary outcome measure is a complete or non-complete colonoscopy with the test instrument. Completion is assessed at the end of each procedure.
次要结局
- Detection of additional colonic pathology(2 hours)
