Evaluation of a Novel Colonoscope Designed for Easier Passage Through Flexures: A Randomised Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Patient Assessment of Pain Experienced During Colonoscopy
研究概览
简要总结
A prototype colonoscope with an extra passively bending distal section has been developed by Olympus Japan (ref. publications). The present study (2006-2007) is testing refinements of this function.
详细描述
Results from the first prototype evaluation has been published.Modifications are presently evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •Patients referred for routine outpatients colonoscopy
排除标准
- •Pregnant women
- •Age below 18 years
研究组 & 干预措施
Prototype colonoscope
Colonoscopy using prototype colonoscope with passive bending function
干预措施: Passive bending function (Device)
Standard colonoscope
Colonoscopy using standard colonoscope with no passive bending function
干预措施: No passive bending function (Device)
结局指标
主要结局
Patient Assessment of Pain Experienced During Colonoscopy
时间窗: Pain experienced during colonoscopy
The proportion of patients reporting "no pain" when examined with prototype or standard colonoscope, respectively. Pain experienced was assessed by the patient in a questionnaire to be filled in at home on the day after the examination and mailed in a pre-paid envelope to a national quality register (Gastronet).
次要结局
未报告次要终点
研究者
Geir Hoff
Head of Research, Telemark Hospital
Norwegian Department of Health and Social Affairs