Three Arm Prospective Randomized Controlled Trial of HD White-light Colonoscopy vs HD White-light Colonoscopy With Reveal® Distal Attachment Cap Versus HD White-light Colonoscopy With Endocuff Vision for the Detection of Colorectal Adenomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,203
- 试验地点
- 1
- 主要终点
- Adenoma detection rate
研究概览
简要总结
Protocol Title: Three Arm Prospective Randomized controlled trial of High-Definition White-light colonoscopy versus High-Definition White-light colonoscopy with Reveal® Distal Attachment Cap versus High-Definition White-light colonoscopy with Endocuff Vision for the detection of colorectal adenomas
Hypothesis: Detection rate of adenomas in patients will be higher in procedures performed with High-Definition White-light (HDWL) colonoscopy with Reveal® distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopes alone
Design: Multicenter, Prospective, randomized controlled study
Primary Aim: To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Secondary Aims: To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
To compare the detection rates for polyp subtypes (including advanced adenomas, serrated polyps, right sided adenomas, etc.), cecal intubation rate, insertion time, withdrawal time, and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
详细描述
Hypothesis and specific aims of the Study
We hypothesize that the detection rate of patients with colorectal adenomas will be higher with HDWL colonoscopy with Reveal® distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopy alone.
Primary Aim:
To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Secondary Aims:
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Randomization will be done by computer allocation
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Referral for screening or surveillance colonoscopy
- •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 anti-platelet agents or anticoagulants that precludes the removal of polyps during the procedure
- •History of polyposis syndrome or HNPCC
- •Inability to give informed consent
- •Family history of colon cancer in a first degree relative < 60 years or two first degree relatives with colorectal cancer
研究组 & 干预措施
High-Definition White-light Colonoscopy
Using an instrument called colonoscope which is used to detect colonic polyps
干预措施: Colonoscopy (Procedure)
High-Definition White-light Colonoscopy With Reveal®
Using an instrument called cap at end of colonoscope which is used to straighten colon folds
干预措施: Colonoscopy (Procedure)
High-Definition White-light Colonoscopy With Reveal®
Using an instrument called cap at end of colonoscope which is used to straighten colon folds
干预措施: distal Cap (Device)
High-Definition White-light Colonoscopy With Endocuff Vision
Using an instrument called Endocuff at end of colonoscope which is used to straighten colon folds
干预措施: Colonoscopy (Procedure)
High-Definition White-light Colonoscopy With Endocuff Vision
Using an instrument called Endocuff at end of colonoscope which is used to straighten colon folds
干预措施: Endocuff (Device)
结局指标
主要结局
Adenoma detection rate
时间窗: Through the study (1 year)
To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
次要结局
- to determine complications(Through the study(1 year))
- detect rates of right sided adenomas(Through the study (1 year))
- to determine cecal intubation time(Through the study (1 year))
- detection rates of advanced adenomas(Through the study (1 year))
- detect rates of serrated polyps(Through the study (1 year))
- to determine insertion and withdrawal time(Through the study (1 year))
- Number of Adenomas per person(Through the study (1 year))