The Use of Magnetic Endoscopic Imaging for Improving Quality Indicators in Outpatient Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 633
- 试验地点
- 2
- 主要终点
- Cecal intubation rate
研究概览
简要总结
Colonoscopy is an important procedure for diagnosing and treating diseases of the colon. In Canada, up to 13% all colonoscopies do not examine the full colon and are therefore incomplete. Incomplete colonoscopies happen for a number of reasons but are often due to twists and turns in the colon that make the colonoscopy difficult to perform and uncomfortable for the patient.
This randomized study is being done to test a new colonoscopy system called the Scope Guide that shows an exact 3-dimensional picture of how the colonoscopy is positioned in the patient's abdomen.
We hypothesize that the use of the Scope Guide for colonoscopy will improve measures of colonoscopy quality including rate of complete examination, patient comfort, polyp detection rate, insertion time, amount of sedation required, and need for abdominal compression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be over the age of 18 presenting for out-patient colonoscopy to the endoscopy unit at the VG Site.
排除标准
- •Inability or unwillingness to provide written informed consent.
- •Previous incomplete or difficult colonoscopy (i.e. independent indication for use of Scope Guide).
- •Colonoscopist not participating in trial.
- •Current pregnancy.
- •Cardiac pacemaker or any other type of implantable stimulator.
- •Previous colectomy, hemicolectomy, segmental colon resection, or ileocecal resection.
结局指标
主要结局
Cecal intubation rate
时间窗: baseline
次要结局
- Patient comfort(baseline)
- Amount of sedation required(baseline)
- Polyp detection rate(baseline)
- Use of abdominal compression(baseline)
- Insertion time(baseline)