NCT00258531已完成4 期
Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy for Visualisation of Endoscope Localisation
Sykehuset Telemark2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2003年6月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Pain experienced during colonoscopy
研究概览
简要总结
- A commercial 3-dimentional magnetic imaging system (Olympus ScopeGuide) is available for routine use during colonoscopy.
- No randomised trials have been performed to evaluate if, and to what extent, the use of this technology may improve the coecal intubation rate and reduce the patient's experience of discomfort and pain by making the insertion of the endoscope easier
详细描述
Endoscopist at different level of experience are to participate. Patients routinely referred to the outpatients department for colonoscopy are asked to participate in a randomised trial where coecal intubation rate and pain experienced by the patient are end-point. Written informed consent is obtained. For each endoscopist, allocated patients are randomised to colonoscopy with no imaging technique (usual care) or using the 3-dimentional imager.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •A successive series of patients referred for routine colonoscopy
排除标准
- •Age under 18 years
- •Pregnant women
- •Persons with pacemaker
- •Unwillingness to restrict sedation to "on demand"
- •Inability to understand the information given
结局指标
主要结局
Pain experienced during colonoscopy
次要结局
- Coecal intubation rate
研究者
研究点 (2)
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