Cap-assisted Sigmoidoscopy - Reduction in Pain, Reduction in Investigation Time and Increased Rate of Success, When Examined by the Less-experienced Endoscopist. A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 2
- 主要终点
- VAS recording of pain
研究概览
简要总结
The purpose of this study is to investigate the attachment of a transparent hood ("cap") on the sigmoidoscope. The investigators hypothesis is that this will reduce pain, reduce investigation time, and increases the success rate of the sigmoidoscopy. The study focus on the less-experienced endoscopist.
详细描述
The investigators randomize study subject to sigmoidoscopy +/- the attachment of the cap.
Using a 100mm VAS scale the investigators record pain when the sigmoidoscopy reaches its intubation end-point (60cm from anus). The investigators also register the time spent to this point and the rate of examinations not achieving this endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •planned to undergo sigmoidoscopy
- •informed consent
排除标准
- •use of iv medication for pain and/or anxiety immediately before the endoscopy
- •lack of indication for a full sigmoidoscopy (eg just need to investigate the rectum)
- •lack or improper administration of standard bowel preparation
结局指标
主要结局
VAS recording of pain
时间窗: During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.
the registration is performed when the endoscopist has advanced the scope to the 60 cm mark.
次要结局
- Time(During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.)
研究者
magnus Ploug
MD, Junior Doctor
Zealand University Hospital