Osmotic or Large Volume Lavage for Optimal Bowel Preparation - a Single-blind Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 2
- 主要终点
- Bowel cleansing quality
研究概览
简要总结
Comparison between large volume and osmotic agent lavage for optimal colonoscopy bowel cleansing, randomizing adult outpatients by invitation letter
详细描述
This randomized quality assurance trial aims to compare cleansing quality of two different principles of colonoscopy lavage. Large volume PEG solutions are considered safe, but cumbersome and inpalatable, while osmotic solutions are generally more acceptable, however, the risk of electrolyte disturbances or renal decompensation may increase.
The study will focus on patient experience and compliance, as well as cleansing quality, endoscopic findings and other technical parameters of the colonoscopy procedure that may be adversely affected by poor bowel cleansing. Three centers will participate, ensuring a diverse patient population. 800 patients are planned for recruitment, but an interim assessment of statistics of the primary aim parameter (bowel cleansing) will be performed to adjust the number.
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 (Investigator)
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
- •Pts for out-patient colonoscopy
- •age 18-80
排除标准
- •Active colitis or suspicion thereof (bloody diarrhea, fever and abdominal pain)
- •Suspicion of renal insufficiency or ileus/subileus
- •Previous colonic surgery
- •Pregnancy
- •Inability to adhere to cleansing instructions
- •Inability to consent
结局指标
主要结局
Bowel cleansing quality
时间窗: 1 Day
次要结局
- Colonoscopy findings(1 Day)
