Prospective Randomized Controlled Trial of High-Definition White-light Colonoscopy Versus High-Definition White-light Colonoscopy With Endocuff Vision for Endpoints of Procedural Times
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision)
研究概览
简要总结
This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).
详细描述
For this study, subjects will be randomized into one of two groups (those who receive a standard colonoscopy and those who receive a colonoscopy with an Endocuff Vision attachment). Results will then be compared between the two; these include insertion time (time it takes to reach the cecum of the large intestine), inspection time (time spent examining the large intestine), the total time per each polypectomy (removal of polyps in the colon), and the total procedure time of the colonoscopy.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject referred for a screening or surveillance colonoscopy
- •Subject is aged 40 years or older
- •Subject has the ability to provide informed consent
排除标准
- •Prior history of colon cancer
- •History of inflammatory bowel disease
- •Prior surgical resection of any part of the colon
- •Use of antiplatelet agents or anticoagulants that precludes the removal of polyps during the procedure
- •History of polyposis syndrome or HNPCC
- •Family history of colon cancer in a first-degree relative < 60 years or two first degree relatives with colorectal cancer
- •Inability to provide informed consent
研究组 & 干预措施
Control Arm (Standard Colonscopy)
Standard colonoscopy with no device attachments
Endocuff Vision
Colonoscopy with Endocuff Vision attached to distal end of scope
干预措施: Endocuff Vision (Device)
结局指标
主要结局
Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision)
时间窗: During the withdrawal portion of the colonoscopy procedure
Inspection time is time spent actually examining the colon. This was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. It was measured during colonoscopy by a study assistant using a stopwatch.
次要结局
- Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision)(During the insertion portion of the colonoscopy procedure)
- Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision)(During the colonoscopy procedure)
- Polyps Per Colonoscopy(During the colonoscopy procedure)
- Detection Rates(During the colonoscopy procedure)
- Boston Bowel Preparation Score(During the withdrawal portion of the colonoscopy procedure after cleaning of the colon)
研究者
Douglas K. Rex
Distinguished Professor
Indiana University