The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 440
- 试验地点
- 2
- 主要终点
- ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap.
研究概览
简要总结
This is a research study about the usefulness of transparent cap during screening colonoscopy. The purpose of the research is to test the usefulness of adding small cap to the tip of the colonoscope. the investigators hypothesis is that Cap assisted colonoscopy will improve the detection of adenomatous polyps (polyps which can become colon cancer later on) in comparison to the standard colonoscopy.
详细描述
This is a prospective, randomized trial comparing the adenoma detection rate between Hispanic patients undergoing a screening colonoscopy with a conventional colonoscope or with a cap-assisted colonoscopy. The aims of the study are:
- Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
- Compare the overall polyp detection rate between Hispanic patients undergoing a screening colonoscopy with and without cap.
- Compare the cecal intubation rate and cecal intubation time between standard colonoscopy and cap assisted colonoscopy.
- Compare the complication rate between standard colonoscopy and cap assisted colonoscopy.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult Hispanic patients (18-80) who are undergoing colonoscopy for screening or surveillance purposes.
排除标准
- •Patients younger than 18 yrs old or older than 80 yrs.
- •Patients with a prior history of colonic surgeries
- •Patient with Crohns colitis or ulcerative colitis.
- •Patient with prior history of colon cancer
- •Patient with poor bowel preparation
结局指标
主要结局
ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap.
时间窗: 1 year
1\. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
次要结局
未报告次要终点
研究者
Mohamed O Othman
Principal Investigator
Texas Tech University Health Sciences Center, El Paso