Warm Water Colonoscopy: a Novel Method for Unsedated Colonoscopy
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 818
- 试验地点
- 4
- 主要终点
- number of patients undergoing complete unsedated or slightly sedated colonoscopy
研究概览
简要总结
Unsedated or slightly sedated colonoscopy has fast recovery time, less cost and lower or no incidence of drug-related side effects. May be slightly painful or discomforting for the patient. Based on numerous recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of warm water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation or with a low dose of sedatives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 Years to 85 Years
- •adult patients willing to undergo colonoscopy without routine initial sedation
排除标准
- •refuse to initiate colonoscopy without routine sedation
- •inadequate bowel preparation
- •incapacity to give informed consent
结局指标
主要结局
number of patients undergoing complete unsedated or slightly sedated colonoscopy
时间窗: 9 months
number of patients undergoing complete unsedated conoloscopy with a pain score (as per used scale) ≤2, or patients with no more than that score AND ≤2 mg Midazolam E.V.
次要结局
- time to reach caecum(1 hour)
- percentage of caecum intubation(1 hour)
- Adenoma detection rate(9 months)
- evaluation of pain and tolerability scores(1 hour)
研究者
Sergio Cadoni, M.D.
Responsabile Servizio Endoscopia Digestiva
Presidio Ospedaliero Santa Barbara