NCT00519129已完成3 期
Magnetic Endoscopic Imaging Versus Standard Colonoscopy in a Routine Colonoscopy Setting: A Randomised Controlled Trial
Sorlandet Hospital HF1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2007年8月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- pain during coloscopy
研究概览
简要总结
Coloscopy may be a painful procedure for the patient. This is due to a loop-formation of the coloscope. A 3D-real time imager produced by Olympus creates a real-time image of the scope while a traditional fluoroscopy device will only show instant pictures. We want to investigate whether the 3D-imager causes the patient less pain and is more time consuming than ordinary fluoroscopy
详细描述
Results published in Holme et.al. Gastrointestinal Endoscopy 2011;73:1215-1222.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •All patients referred for coloscopy on an out-patient basis
排除标准
- •Pregnancy
- •Pacemaker
- •Lack of ability to understand information given
- •Prior resection of the colon/rectum
- •Demanding analgetics prior to start of procedure
结局指标
主要结局
pain during coloscopy
时间窗: instant
Time used to reach the coecum
时间窗: instant
次要结局
- Polyp detection rate(instant)
- Pain during the first 24 hours after coloscopy(24 hours)
- coecum-intubation rate(instant)
- level achieved when the coecum can not be reached(instant)
- Need for assistance by a colleague(instant)
- Need for analgetics(instant)
研究者
研究点 (1)
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