NCT01398020已完成不适用
Oral 2L Bi-PegLyte Versus 4L PegLyte Regimen for Outpatient Colonic Preparation: A Randomized, Non-Inferiority Open Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- Difference in Boston Bowel Preparation Scale between the two groups
研究概览
简要总结
The investigators wish to compare the efficacy and patient tolerability of a preparation consisting of 2L Bi-Peglyte plus 15mg of bisacodyl vs the standard preparation of 4L Peglyte. The investigators hypothesize that 2L Bi-Peglyte with 15mg bisacodyl will show higher efficacy and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 or older
- •Outpatient colonoscopy
排除标准
- •constipation
研究组 & 干预措施
Standard bowel prep
Active Comparator
Subject will receive standard bowel prep prior to colonoscopy.
干预措施: Standard Bowel Prep (Drug)
2L Bi-Peglyte
Experimental
Subjects will be asked to take 2L Bi-Peglyte + 15mg bisacodyl for bowel prep the day before colonoscopy.
干预措施: 2L Bi-Peglyte Bowel Prep (Drug)
结局指标
主要结局
Difference in Boston Bowel Preparation Scale between the two groups
时间窗: 30 minutes
This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared between the two groups.
次要结局
- Difference in the number of participants who develop distress symptoms from bowel prep (and the type) between the two groups(20 hours)
- Difference in the absolute number/percentage of participants in the two groups who find the bowel prep experience easy, acceptable, difficult, very difficult, or unable to complete.(20)
研究者
研究点 (1)
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