跳至主要内容
临床试验/NCT01510977
NCT01510977终止4 期

The Outcome of a Second Preparation for Colonoscopy After Preparation Failure in the First Procedure: a Prospective Randomized Controlled Study

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
150
试验地点
1
主要终点
second colonoscopy failure due to inadequate bowel preparation (PEG+bisdacodyl group)

研究概览

简要总结

Colonoscopy is a basic but important tool to diagnose and treat lesions of the colon. Proper colon cleansing is essential for colonoscopy to be performed with a good quality. Inadequate bowel preparation leads to longer colonoscopic insertion time and patient discomfort, as well as inadequate diagnostic yield of colonic lesions. Frequency of colonoscopy failure due to bad bowel preparation is reported to be 0.3% to 6.5 percent, and the rate increases with liver cirrhosis, constipation, dementia, stroke, or administration of tricyclic antidepressants. In case of colonoscopy failure due to bad bowel preparation, the second colonoscopy can be performed with either adding a colon cleansing solution immediately, or it can be performed after a few days with colon cleansing agent together with prokinetics. These different kinds of bowel preparations after first colonoscopy failure have not been compared.

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

入选标准

  • First colonoscopy failure due to inadequate bowel preparation

排除标准

  • younger than 18 years old
  • presence of inflammatory bowel disease
  • lactating

研究组 & 干预措施

PEG

Active Comparator

2L of polyethylene glycol addition immediately after first colonoscopy failure

干预措施: polyethylene glycol (Drug)

PEG + bisacodyl

Experimental

One week after initial colonoscopy failure, conventional amount (5L) of polyethylene glycol together with bisacodyl administration

干预措施: polyethylene glycol, Bisacodyl (Drug)

结局指标

主要结局

second colonoscopy failure due to inadequate bowel preparation (PEG+bisdacodyl group)

时间窗: one week

second colonoscopy failure due to inadequate bowel preparation (PEG group)

时间窗: within the same day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeong-Sik Byeon

Clinical Professor

Asan Medical Center

研究点 (1)

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