Cap-assisted Water Immersion Versus Water Immersion Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 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. Cap attached to the colonoscope tip may improve insertion and shorten cecal intubation time. The investigators would like to assess whether combination of cap-fitted colonoscopy and water immersion insertion is feasible and safe method of diagnostic colonoscopy. The primary endpoint is cecal intubation time and the investigators suppose that the use of cap is able to 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 are 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
- 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
- •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
研究组 & 干预措施
cap-assisted water immersion colonoscopy
Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
干预措施: soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope (Device)
water immersion colonoscopy
Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
干预措施: water immersion colonoscopy (Procedure)
结局指标
主要结局
Cecal Intubation Time
时间窗: 3 months
The primary endpoint (cecal intubation time) was defined as a 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)
- Success Rate of Minimal Sedation Colonoscopy(3 months)
研究者
Premysl Falt MD
Principal Investigator
Vitkovice Hospital
