Water Exchange Versus Carbon Dioxide Insufflation to Improve Colonoscopy Screening - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 473
- 试验地点
- 4
- 主要终点
- Pain during colonoscopy
研究概览
简要总结
Colonoscopy is commonly used in screening for colorectal cancer. A refined technique of colonoscopy involving the use of water as the sole modality to aid colonoscope insertion, water exchange, has been described in recent research papers to decrease patient discomfort and pain, and to reduce the need for sedation during colonoscopy when compared with standard air insufflation. Carbon dioxide insufflation has been described to decrease patient discomfort after colonoscopy. No randomized trial has so far compared the use of water exchange to carbon dioxide insufflation. Our hypothesis is that water exchange inflicts less discomfort to patients undergoing colonoscopy than carbon dioxide insufflation. Patients undergoing screening colonoscopy in two centers in Norway, one center in Poland and one center in The Netherlands will be enrolled and randomized to examination of either of the two methods.
详细描述
Single blinded randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for screening or polyp surveillance colonoscopy
- •Patients accepting sedation on demand
排除标准
- •Demand for sedation/analgesia before the start of the procedure
- •Previous partial or total colonic resection
- •Pregnancy
- •Unwilling/unable to provide informed consent
结局指标
主要结局
Pain during colonoscopy
时间窗: 1 hour
Patients will be asked by a blinded assistant immediately after colonoscopy to score pain during the procedure.
次要结局
- Pain during colonoscopy(30 minutes)
- Cecal intubation rate(1 hour)
- Cecal intubation time(1 hour)
- Adenoma detection rate(1 hour)
- Polyp detection rate(1 hour)
- Dose of medication(1 hour)
