Efficacy of Segmental Re-examination and Retroflexion of Proximal Colon for Adenoma Miss Rate During Colonoscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- Adenoma miss rate in the proximal colon (AMR)
研究概览
简要总结
The primary aim of this study is
- to explore the usefulness of re-examination and retroflexion on adenoma miss rate (AMR) in the proximal colon.
Other aims include to explore the data below when re-examination or retroflexion is used.
- Adenoma detection rate, ADR
- Polyp miss rate, PMR
- Polyp detection rate, PDR
- Withdrawal time, WT
详细描述
AMR = number of adenomas missing during the first examination/ total number of adenomas in both examinations = number of adenomas detected only in the second examination/(number of adenomas detected during the first examination + number of adenomas detected only in the second examination)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between 45 and 80 years who undergo colonoscopy examination for screening, and who receive primary screening and get positive result
排除标准
- •Pregnant female patients
- •Patients received colonoscopy in the past 5 years
- •Patients who have history of colorectal cancer, colorectal polyposis, inflammatory bowel disease or heredity colorectal neoplasm syndrome such as familiar adenomatous polyposis, Lynch Syndrome and so on
- •Patients who had previous abdominal surgery
- •Patients who are known to have colonic stricture or obstructing tumor from the results of radiography (X ray, CT scan or barium enema)
- •Patients who are presenting acute surgical conditions such as severe colitis, megacolon and active gastrointestinal bleeding
- •Patients who have inadequate bowel preparation
- •Patients who reject to participate in this study
研究组 & 干预措施
Re-examination Group
Routine intubation is performed. After cecal intubation, the cecum and ascending colon is examined with colonoscope tip in forward direction for the first time. Re-intubation is performed after the first examination of the cecum and ascending colon, and then this region of the large bowel is re-examined in the same fashion. After that, the rest of the colon is examined in routine method.
干预措施: Re-examination (Procedure)
Retroflexion Group
Routine intubation is performed. After cecal intubation, the cecum and ascending colon is examined with colonoscope tip in forward direction for the first time. Re-intubation is performed after the first examination of the cecum and ascending colon, and then this region of the large bowel is re-examined with the colonoscope tip in reverse direction (retroflexion fashion). After that, the rest of the colon is examined in routine method.
干预措施: Retroflexion (Procedure)
结局指标
主要结局
Adenoma miss rate in the proximal colon (AMR)
时间窗: At the end of the procedure, up to 1 hour
AMR refers to the rate of adenoma missing, calculated as the proportion of adenomas which are missing in the first examination. AMR in the proximal colon is calculated with only the proximal colon concerned.
次要结局
- Adenoma Detection Rate in the proximal colon (ADR)(At the end of the procedure, up to 1 hour)
研究者
En-Da Yu
Director of Department of Colorectal Surgery and Vice Director of GI Endoscopy
Changhai Hospital