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临床试验/NCT01587872
NCT01587872终止不适用

Double-balloon Colonoscopy to Increase Cecal Intubation Rate in Technically Difficult Colonoscopies

Sorlandet Hospital HF2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2011年10月1日最近更新:
适应症

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

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)

研究者

发起方
Sorlandet Hospital HF
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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