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临床试验/NCT01452737
NCT01452737撤回不适用

2L Golytely and Oral Bisacodyl 15 mg Versus 4L Golytely Regimen for Inpatient Colonoscopy Bowel Preparation: A Randomized, Non-Inferiority Open Trial

University of British Columbia1 个研究点 分布在 1 个国家开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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