Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 792
- 试验地点
- 3
- 主要终点
- Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy.
研究概览
简要总结
The proposed research aims to determine the prevalence, size, shape and histology of flat colorectal neoplasms in a cohort of asymptomatic, average-risk individuals presenting for screening colonoscopy. Patients will be randomized to either conventional colonoscopy or chromocolonoscopy, where the entire colon will be sprayed with indigocarmine dye and examined in the usual manner. The primary outcome will be the total number of adenomas detected, with special attention to the subgroup of flat and depressed lesions. To promote the generalizability of the results, neoplasms will be described according to standard Western and Japanese classification schemes.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing screening colonoscopy
排除标准
- •Age < 50
- •Prior colon resection
- •Inflammatory bowel disease
- •Prior colonoscopy or sigmoidoscopy
- •More than one first-degree relative with colon cancer
研究组 & 干预措施
1
Chromocolonoscopy
干预措施: Chromocolonoscopy (Procedure)
结局指标
主要结局
Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy.
时间窗: Cross-sectional prevalence of adenomas between the 2 study groups
次要结局
未报告次要终点
