NCT00905554已完成不适用
Warm Water Irrigation Versus Standard Air Insufflation for Unsedated Colonoscopy: a Randomized Controlled Trial
Valduce Hospital2 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2009年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Number of Patients Undergoing Complete Unsedated Colonoscopy
研究概览
简要总结
Unsedated colonoscopy is characterized by lower costs, recovery time and incidence of drug-related side effects, although it may be painful for the patient. Based on recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult outpatients 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 Colonoscopy
时间窗: 6-9 months
次要结局
- Evaluation of Pain and Tolerability Scores(6-9 months)
研究者
Vittorio Terruzzi
MD
Valduce Hospital
研究点 (2)
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