NCT04107376Unknown不适用
Inspection of the Colon Using a Retrograde Viewing Device for Detection of Colorectal Polyps
University of Erlangen-Nürnberg Medical School2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Adenoma detection rate
研究概览
简要总结
During standard colonoscopy a substantial number of colorectal polyps may be missed. Previous studies have found a 12-28% of miss rate for all polyps, a 31% for hyperplastic polyps and 6-27% for adenomas. In this study it is tested whether a retro viewing endoscope can detect more colorectal polyps in comparisson to standard forward viewing endoscopy. Further, ppolyps detected, mean adenomas per Patient and withdrawal time are recorded.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •screening colonoscopy
- •18 years of age
排除标准
- •inflammatory bowel disease
- •inadequate bowel preparation
结局指标
主要结局
Adenoma detection rate
时间窗: 8 months
calculation of the adenoma detection rate in each arm
次要结局
- Polyp detection rate(8 months)
- Withdrawal time(8 months)
- Mean number of adenomas per patient(8 months)
研究者
Timo Rath
Prof. Dr. Timo Rath
University of Erlangen-Nürnberg Medical School
研究点 (2)
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