跳至主要内容
临床试验/NCT01894191
NCT01894191已完成不适用

A Randomized, Controlled Trial Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange During Colonoscopy

Dalin Tzu Chi General Hospital4 个研究点 分布在 2 个国家目标入组 651 人开始时间: 2013年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
651
试验地点
4
主要终点
adenoma detection rate

研究概览

简要总结

Interval (missed) cancers and lower than expected mortality reduction of proximal colon cancers in the United States and elsewhere after screening colonoscopy drew attention to quality indicators. Missed adenomas which are more likely to be in the proximal colon may be contributing factors. An independent predictor of the risk of interval cancers is adenoma detection rate. In pilot observations, the investigators showed that water exchange enhanced adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized controlled trial will compare water exchange with water immersion and traditional air insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that compared with air insufflation and water immersion, water exchange produces a significantly higher adenoma detection rate in the right colon.

详细描述

All of the procedures will be recorded and stored as digital files.

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
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing colonoscopy performed by the participating endoscopists

排除标准

  • obstructive lesions of the colon known before colonoscopy
  • massive ascites
  • past history of partial colectomy
  • refusal to provide written informed consent

结局指标

主要结局

adenoma detection rate

时间窗: one week

次要结局

  • adenoma detection rate in proximal colon(one week)

研究者

发起方
Dalin Tzu Chi General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu-Hsi hsieh

Doctor

Dalin Tzu Chi General Hospital

研究点 (4)

Loading locations...

相似试验