Adenoma Detection Rate With a New Pediatric Colonoscope With a Short Turn Radius (Pentax Retroview) Compared With a Standard Pentax Pediatric Colonoscope
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 283
- 主要终点
- Percentage of Patients With At Least One Adenoma
研究概览
简要总结
The purpose of this study is to determine whether the new colonoscope that provides both a traditional and a retrograde view (bending 180 degrees to look behind itself) of the colon can detect more polyps than a standard colonoscope that only provides a forward-facing view. The investigators wish to effectively demonstrate the utility of the new colonoscope (Pentax Retroview Colonoscope) as the objective of this study is to determine polyp and adenoma detection rates in human subjects undergoing colonoscopy for polyp surveillance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Ability to provide Informed Consent
- •Age > 40
- •Surveillance Colonoscopy (History of Adenomas)
排除标准
- •Poor or Fair Bowel Prep
- •Difficult First Insertion
- •Familial Polyposis
- •Inflammatory Bowel Disease
- •Pregnancy
- •Active GI Bleeding
- •Prior colonic or rectal resection
- •Conserved Sattus
- •Colonoscopy less than 3 years ago
- •Screening Colonoscopy
- •Colonoscopy done to evaluate systems like abdominal pain, diarrhea, constipation, change in bowel habits
研究组 & 干预措施
Short-Turn Radius Colonoscope
Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.
干预措施: Short-Turn Radius Colonoscope (Device)
Conventional Pediatric Colonoscope
Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.
干预措施: Conventional Pediatric Colonoscope (Device)
结局指标
主要结局
Percentage of Patients With At Least One Adenoma
时间窗: 1 hour
Compare adenoma detection rate between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.
次要结局
- Mean Number of Adenomas Identified Per Patient With Polyps(1 hour)
- Overall Polyp Detection Rate(1 hour)
研究者
Norman Nishioka, MD
Director of Endoscopy
Massachusetts General Hospital