Endo-cuff Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening Patients: A Randomised Controlled Trial. The E-CAP Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 534
- 试验地点
- 2
- 主要终点
- Number of polyps detected per patient
研究概览
简要总结
The study evaluates whether the use of a novel endoscopic cap (the endo-cuff) at the tip of a colonoscope improves the numbers of polyps detected during bowel cancer screening colonoscopy. Half the patients will have standard colonoscopy and half will have colonoscopy with the cap attached.
详细描述
Problem statement:
In England, everyone in the age group of 60-69 years is invited to participate in bowel cancer screening. Those who test positive in the initial screening stool test are invited to have a colonoscopy. The purpose of colonoscopy is to detect any obvious cancers, and in the absence of obvious cancers the purpose is to detect and remove all the polyps present in the colon, as polyps have the potential to develop into cancers. However, colonoscopy still misses up to 25% of polyps. Cap assisted colonoscopy improves polyp detection but still misses a significant number of polyps. There is a need for an improved cap design which will help improve polyp detection.
Research question/hypothesis:
Does using an endocuff on a colonoscope improve polyp detection as compared to standard colonoscopy in bowel cancer screening patients?
Study design:
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
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred for colonoscopy under the national bowel cancer screening programme
- •Able to provide written informed consent
排除标准
- •History of Inflammatory bowel disease
- •History of Hereditary non polyposis colorectal cancer
结局指标
主要结局
Number of polyps detected per patient
时间窗: 1 month (when pathology report available)
次要结局
- Polyp detection rate(1 month (when pathology report available))
- Adenoma detection rate(1 month (when pathology report available))
- Cancer detection rate(1 month (when pathology report available))
- Patient comfort score(1 day)
- Adenomas per patient(1 month (when pathology report available))
- Caecal intubation rate(1 day)
- Total procedure time - from scope insertion to removal(1 day)
- Time taken to reach caecum(1 day)
- Time taken to withdraw scope (from caecum to removal of scope)(1 day)