2L Golytely and Oral Bisacodyl 15 mg Versus 4L Golytely Regimen for Inpatient Colonoscopy Bowel Preparation: A Randomized, Non-Inferiority Open Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Difference in Boston Bowel Preparation Scale & Ottawa 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 Golytely (PEG + electrolytes) plus 15mg of bisacodyl vs the standard preparation of 4L Golytely. The investigators hypothesize that 2L Golytely with 15mg bisacodyl will show similar bowel cleansing efficacy while offering better tolerability.
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
- Single (Outcomes Assessor)
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
- •Inpatients undergoing colonoscopy
- •Age 19 or over
排除标准
- •Unable to provide informed consent
- •Patients with constipation
- •Patients with suspected bowel obstruction or severe inflammatory bowel disease
- •Same-day colonoscopy
- •Intensive/critical care patient
- •History of colorectal resection
研究组 & 干预措施
2L Golytely/15mg bisacodyl
Subjects will be asked to take 2L Golytely + 15mg bisacodyl for bowel prep the day before colonoscopy.
干预措施: 2L Golytely/bisacodyl (Drug)
Standard bowel prep
Subject will receive standard bowel prep (4L Golytely) prior to colonoscopy.
干预措施: Standard Bowel Prep (Drug)
结局指标
主要结局
Difference in Boston Bowel Preparation Scale & Ottawa Bowel Preparation Scale between the two groups
时间窗: 30min
These are established rating scales to evaluate the quality of bowel prep. The ratings will be compared between the two groups.
次要结局
- 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.(20hours)
- Difference in the number of participants who develop distress symptoms from bowel prep (and the type) between the two groups(20hours)
