The Utility of Timed Segmental Withdrawal During Screening Colonoscopy for Increasing Adenoma Detection Rate. A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 326
- 试验地点
- 2
- 主要终点
- The Polyp detection rate( PDR) and Adenoma detection rate (ADR) of patients undergoing screening colonoscopy either with 6-minutes or 8-minutes protocols of the segmental withdrawal.
研究概览
简要总结
The purpose of colonoscopy (colon examination with flexible tube and a camera) is to find early precancerous growth in the colon (polyps) and remove them before they turn into cancer. The doctor performing the procedure will first advance the colonoscope to the end of the colon (cecum) and then he will examine the colon for polyps while he is withdrawing the colonoscope. The period of time that the doctor spent examining the colon called "withdrawal time". Usually doctors will spend at least 6 minutes examining the colon after he reached the cecum. The investigators are proposing that dedicating half of the withdrawal time during colonoscopy in examining the right side of the colon, will increase the detection of polyps in the right side of the colon.
详细描述
Research design: This is a prospective, randomized trial comparing the ADR between patients undergoing a screening colonoscopy in four different groups: 1) at least 3 minutes from the total withdrawal time dedicated to the right side of the colon, 2) at least 4 minutes from the total withdrawal time dedicated to the right side of the colon, 3) 6 minutes total withdrawal time regardless of time spent in any segment, 4) 8 minutes total withdrawal time regardless of the time spent in any segment. Randomization will be done in blocks after stratification. Four gastroenterologists and two fellows matched base on similar ADR and stratified on each arm of the study (segmental versus non-segmental withdrawal) will be performing the procedures. The estimated sample size of the four arms of the study is 400 patients.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults undergoing colonoscopy for screening or surveillance purposes
排除标准
- •prior history of colonic surgeries
- •Crohn's colitis or ulcerative colitis
- •prior history of colon cancer
- •poor bowel preparation
- •pregnancy
结局指标
主要结局
The Polyp detection rate( PDR) and Adenoma detection rate (ADR) of patients undergoing screening colonoscopy either with 6-minutes or 8-minutes protocols of the segmental withdrawal.
时间窗: 30 minutes
Compare PDR and ADR between patients undergoing a screening colonoscopy with at least 6-minutes protocol versus at least 8-minutes protocol within each segmental and non-segmental withdrawal protocol.
Polyp detection rate (PDR) and Adenoma detection rate (ADR) of patients undergoing a screening colonoscopy either with segmental withdrawal protocol or with non-segmental withdrawal protocol.
时间窗: 30 minutes
Compare polyp detection rate (PDR) and ADR between patients undergoing a screening colonoscopy with segmental withdrawal protocol and with non-segmental withdrawal protocol.
次要结局
- The polyp detection rate( PDR) and Adenoma detection rate (ADR) of patients undergoing screening colonoscopy either with 3-minutes or 4-minutes protocols of the non segmental withdrawal(30 minutes)
- Complication rate(1 month)
研究者
Marc Zuckerman
Professor
Texas Tech University Health Sciences Center, El Paso