NCT03428724Unknown4 期
A Randomized Clinical Trial Comparing Standard and Invidualized Bowel Preparation for Colonoscopy
Clinical Hospital Colentina2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2018年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- bowel preparation quality
研究概览
简要总结
A randomized control trial comparing a standard bowel preparation for colonoscopy with an individualized bowel preparation strategy based on patient characteristics
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
single-blind
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
- •elective out-patient diagnostic or therapeutic colonoscopy
排除标准
- •pregnant women; refusal to participate; significant comorbidities (ASA score 3 or above); suspicion of bowel perforation;
研究组 & 干预措施
standard group
Active Comparator
standard polyethylene glycol preparation for colonoscopy
干预措施: Standard Preparation (Drug)
individualized group
Experimental
either a low or a high volume bowel preparation according to patient characteristics
干预措施: Individualized Preparation (Drug)
结局指标
主要结局
bowel preparation quality
时间窗: 1-2 hours after completing bowel preparation
Boston bowel preparation score (BBPS)
次要结局
- patient comfort during bowel preparation(1-2 hours after completing bowel preparation)
研究者
dr. Theodor Alexandru Voiosu
MD, PhD
Clinical Hospital Colentina
研究点 (2)
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