Can Involvement of Endoscopy Nurse Participation Increase Adenoma Detection Rate During Screening Colonoscopy?:A Prospective Multicenter Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 844
- 试验地点
- 6
- 主要终点
- adenoma detection rate
研究概览
简要总结
Colorectal cancer (CRC) is the second most common cancer and the fourth leading cause of cancer death in Korea. Colonoscopy with polypectomy decreases the incidence and mortality from colorectal cancer. However, significant lesions can be missed during colonoscopy. Recent retrospective studies have shown that fellow involvement as a second observer may increase adenoma detection rate in colonoscopy.
The aim of this prospective, multicenter, randomized study is to evaluate the impact when endoscopy nurse participate in adenoma detection during screening colonoscopy. The primary outcome measure is the adenoma detection rate (ADR).
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
- •age over 50
- •screening colonoscopy
排除标准
- •History of colorectal surgery
- •History of hereditary colorectal cancers or polyposis syndrome
- •Gastrointestinal bleeding
- •Inflammatory bowel diseases
- •Inability to provide informed consent
- •Pregnancy
研究组 & 干预措施
endoscopist only
干预措施: standard of care colonoscopy (Procedure)
nurse participation
干预措施: standard of care colonoscopy (Procedure)
结局指标
主要结局
adenoma detection rate
时间窗: 1 year
次要结局
- subjects with at least one polyp(1 year)
- Subjects with at least one adenoma(1 year)
- total number of polyp(1 year)
- total number of adenoma(1 year)
- Subjects with at least one advanced adenoma or cancer(1 year)
- total number of advanced adenoma or cancer(1 year)
- polyp and adenoma detection rate according to the endoscopists or nurse experience(1 year)