Warm Water Versus Room Temperature Water Immersion Colonoscopy - a Prospective, Randomized, Double-blind, Single-center Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- Cecal Intubation Time
研究概览
简要总结
Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. There was used warm water infusion for colonoscope insertion in most of the water immersion colonoscopy trials.
The investigators have been using room temperature water (20-24°C) for water immersion and the investigators did not notice any drawback of it. In our opinion, it is simpler and cheaper option for water immersion colonoscopy and proof of its efficacy and safety could support the use of water immersion technique in routine practice.
The primary endpoint is cecal intubation time and the investigators suppose that the use of warm water infusion does not shorten it significantly. Patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy will be also assessed.
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
- Double (Participant, Investigator)
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
- •outpatient diagnostic colonoscopy
- •bowel prep with macrogolum
- •initial 2 mg of midazolam i.v.
- •signed informed consent form
排除标准
- •planned therapeutic intervention
- •colorectal surgery in history
- •known inflammatory bowel disease or colorectal cancer
- •refusal of sedation
结局指标
主要结局
Cecal Intubation Time
时间窗: 1-30
= time between introduction of the colonoscope into the anus and reaching the cecum.
次要结局
- Patient Comfort During Insertion Phase of the Colonoscopy(3 months)
研究者
Premysl Falt MD
Principal Investigator
Vitkovice Hospital