The Effects of the Water-exchanged Colonoscopy on Adenoma Detection Rate: a Multicenter, Randomized, Single Blind, Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,303
- 试验地点
- 6
- 主要终点
- Adenoma detection rate
研究概览
简要总结
Water exchange method has been shown to reduce medication requirement and pain experienced during colonoscopy. It may increase the adenoma detection rate (ADR). Water exchange provides salvage cleansing and the refractive index of water (n equals about 1.3) is larger than that of air, which creates optical distortion that likely contributes to objects appearing larger underwater, making smaller lesions easier to visualize and it may help draw attention to those smaller lesions during withdraw. These principles facilitate to the higher adenoma detection rate.
There is a large number of literature on the adenoma detection rate during water exchange colonoscopy, but most studies have been conducted in only one centre, simple-size, and under sedation patients, the influence of adenoma detection rate under unsedation patients was unclear.
The aim of this study is to compare the ADR of colonoscopy by using the water exchange method versus the conventional air method in unsedation patients in multiple centers in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-80 patients with intact colon and rectum
排除标准
- •prior finding of severe colorectal stricture;
- •solid fetus contained in the last stool before colonoscopy
- •no bowel preparation or cleansed by enema/lavage
- •without the requirement of reaching cecum
- •known colorectal polyps or polyposis syndrome without complete removal previously
- •pregnant women
- •hemodynamically unstable
- •patients who cannot give informed consent
结局指标
主要结局
Adenoma detection rate
时间窗: up to one year
The proportion of participants with at least one adenoma in each group
次要结局
- Cecal intubation success rate(up to one year)
- Cecum intubation time(up to one year)
- Pain Scores on the Visual Analog Scale(up to one year)
- Quality of Bowel Preparation(up to one year)
研究者
Yanglin Pan
Associated professor
Air Force Military Medical University, China