The Use of Magnetic Endoscopic Imaging for Improving Quality Indicators in Outpatient Colonoscopy (SCOPE GUIDE)
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Nova Scotia
-
Halifax、Nova Scotia、加拿大、B3H 1V7
- Capital District Health Authority
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participants must be over the age of 18 presenting for out-patient colonoscopy to the endoscopy unit at the VG Site.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
无干预:标准结肠镜检查
|
|
实验性的:Magnetic endoscopic imaging colonoscopy
|
Colonoscopy using the Scope Guide system (Olympus Canada Inc.) by
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Cecal intubation rate
大体时间:baseline
|
baseline
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Patient comfort
大体时间:baseline
|
baseline
|
Amount of sedation required
大体时间:baseline
|
baseline
|
Polyp detection rate
大体时间:baseline
|
baseline
|
Use of abdominal compression
大体时间:baseline
|
baseline
|
Insertion time
大体时间:baseline
|
baseline
|
合作者和调查者
调查人员
- 首席研究员:Donald MacIntosh, MD、Nova Scotia Health Authority
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- NCT12345678
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.