A Randomized, Controlled Trial Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 371
- 试验地点
- 3
- 主要终点
- adenoma detection rate in the right colon
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
- Double (Participant, Outcomes Assessor)
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
- 否
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 in the right colon
时间窗: one week
次要结局
- post-procedure discomfort(1 day after colonoscopy)
- overall adenoma detection rate(one week)
- 30 days complication rate(30 days)