Assessing Effect of Withdrawal Time on Adenoma Detection Rate for Screening Colonoscopy: A Randomized Tandem Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Miss rate of polyps
研究概览
简要总结
The investigators' null hypothesis is that a withdrawal time of 9 to 10 minutes is non-inferior to a withdrawal time of 12 minutes or greater. Thus, the goal of this tandem design trial is to compare the additional diagnostic yield (# of missed lesions) for withdrawal times exceeding 10 minutes for screening/surveillance colonoscopies. Although withdrawal times longer than the standard 6-minute recommendation have been shown to be beneficial, there is limited prospective evidence investigating the benefit or lack thereof for withdrawal times greater than 9-10 minutes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be between the ages of 18 and 75 years
- •Must be a patient undergoing screening or surveillance colonoscopy
- •Must be able to understand and willing to sign an IRB-approved written informed consent document.
排除标准
- •Inability to provide informed consent.
- •Personal history of colorectal cancer (CRC)
- •Personal history of colon surgery or colon resection
- •Personal history of Inflammatory bowel disease
- •Personal history of familial polyposis
- •Current pregnancy
- •Active GI bleeding
- •Colonoscopy exams where the cecum cannot be reached (randomization will occur after cecum is reached).
研究组 & 干预措施
Arm 1: Colonoscopy 6 minute withdrawal time
-Undergo colonoscopy with the standard 6-minute withdrawal time followed by a tandem colonoscopy of at least another 6-minute withdrawal time.
干预措施: Colonoscopy with 6 minute withdrawal (Procedure)
Arm 2: Colonoscopy 9 minute withdrawal time
-Undergo a 9-minute withdrawal time followed by a tandem colonoscopy with at least the standard 6-minute withdrawal time.
干预措施: Colonoscopy 9 minute withdrawal (Procedure)
Arm 3: Colonoscopy 12 minute withdrawal time
-Undergo colonoscopy with a 12-minute withdrawal time followed by a tandem colonoscopy with at least the standard 6-minute withdrawal time
干预措施: Colonoscopy 12 minute withdrawal (Procedure)
结局指标
主要结局
Miss rate of polyps
时间窗: Time of colonoscopy (day 1)
* Miss rate = missed polyps/missed polyps + polyps found during 1st exam * Polyps is defined as adenomas and sessile serrated adenomas (SSA)
次要结局
- Miss rate of advanced adenomas(Time of colonoscopy (day 1))