Usefulness of Endocuff in the Adenoma Detection Rate. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Measurement of the polyp detection rate
研究概览
简要总结
Colorectal cancer (CRC) is one of the leading causes of cancer death worldwide. The cumulative risk of developing CRC is about 6% lifelong.
The benefit of screening colonoscopy depends on the detection and removal of all adenomas, however, some of these may be difficult to detect.
The "endocuff" (EC) is a polymer sleeve which joins the tip of the colonoscope to improve the image viewing of the mucosa during colonoscopy procedure.
There is insufficient evidence of the usefulness of endocuf
详细描述
All patients requiring colonoscopy for screening and who agree to participate in the study will be included and randomized them to make an standard colonoscopy or colonoscopy with endocuff, for randomization system will be used in balanced blocks of 4, created on the page randomization.com.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult patients,
- •Who would come to colonoscopy for colon cancer screening without prior colonoscopy studies
排除标准
- •Boston colonic preparation <5 points
- •Suspected Lynch syndrome or familial adenomatous polyposis (FAP)
结局指标
主要结局
Measurement of the polyp detection rate
时间窗: 30 minutes
Percentage of polyps detected during colonoscopy
Adenoma detection rate
时间窗: 30 minutes
Percentage of adenomas detected during colonoscopy
次要结局
- ileal intubation rate(10 minutes)
- Difficulty performing polypectomy(10 minutes)
- Complications during colonoscopy(One week)
- Cecal intubation rate(30 minutes)
研究者
Dr. Rafael Barreto Zúñiga
Attached to the Department of Endoscopy Medical Institute
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran