A Randomized Trial Comparing the Adenoma Detection Rates Between EndoRings Colonoscopy (EC) and Standard Colonoscopy (SC).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 592
- 试验地点
- 2
- 主要终点
- Adenoma Detection Rates
研究概览
简要总结
The study aims to compare the results between a standard colonoscopy to a colonoscopy with an attachment on the distal end of the colonoscope.
详细描述
This will be a prospective, randomized controlled study. Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled. This study aims to compare the adenoma detection rates between EndoRings colonoscopy (EC) and Standard colonoscopy (SC). It is assumed that the proportion of patients with at least one adenoma would be 25% with SC and 35% with EC.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Screening or Surveillance Colonoscopy
- •Able to provide written informed consent
排除标准
- •Known narrow colon or colon stenosis
- •Personal history of Colorectal cancer
- •History of inflammatory bowel disease
- •Familial adenomatous polyposis syndrome (FAP)
- •Hyperplastic polyposis syndrome
- •Referral for incomplete colonoscopy or polyp clearance
研究组 & 干预措施
Control Arm (Standard Colonoscopy)
Standard colonoscopy with no device attachment.
EndoRings Colonoscopy
Colonoscopy with EndoRings device attached to the distal end of the scope.
干预措施: EndoRings device (Device)
结局指标
主要结局
Adenoma Detection Rates
时间窗: During colonoscopy procedure
Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings.
Number of Adenomas Per Colonoscopy
时间窗: During colonoscopy procedure
Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy.
次要结局
- Polyp Detection Rate(During colonoscopy procedure)
- Problems Encountered With Equipment(During colonoscopy procedure)
- Total Number of Detections(During colonoscopy procedure)
- Cecal Intubation Rate(During colonoscopy procedure)
- Time Comparison for Each Method(During colonoscopy procedure)
- Number of Detections Per Colonoscopy(During colonoscopy procedure)
- Patient Comfort Score(After colonoscopy was completed while patient was in recovery area of endoscopy unit)
研究者
Douglas K. Rex
Professor of Medicine
Indiana University