The Use of Sennosides With Pico Salax in Bowel Preparation for Colonoscopy: a Study of Optimal Dose and Timing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Bowel movements, as measured by patient diary
研究概览
简要总结
The objective of this study is to evaluate sennosides as an adjunct to sodium picosulfate magnesium citrate (Pico Salax) in preparation for colonoscopy. We will compare different doses and administration times. The primary outcome is number of bowel motions produced. Secondary outcomes include the quality of bowel cleansing and patient tolerability.
详细描述
We will compare different doses and administration times in patients booked for morning colonoscopy. The primary outcome is number of bowel motions produced in total by the sennosides. Secondary outcomes include the quality of bowel cleansing and patient tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and non-pregnant female patients 18 to 75 years of age inclusive
- •Patients who require an outpatient colonoscopy with a split dose Pico-Salax prep
排除标准
- •Colonoscopy requiring the use of a large volume prep (eg Colyte, PEG)
- •Ileus or bowel obstruction
- •Previous colorectal surgery
- •Recognized renal impairment (defined as GFR less than normal in 3 months prior to enrolment)
- •Pregnancy
- •Recent (<6 months) myocardial infarction or unstable angina.
研究组 & 干预措施
2 TABS QHS
Sennosides 2 tabs, taken two nights before the colonoscopy
干预措施: Sennosides (Drug)
3 TABS QHS
Sennosides 3 tabs, taken two nights before the colonoscopy
干预措施: Sennosides (Drug)
2 TABS AM
Sennosides 2 tabs, taken the morning before the colonoscopy
干预措施: Sennosides (Drug)
3 TABS AM
Sennosides 3 tabs, taken the morning before the colonoscopy
干预措施: Sennosides (Drug)
2 TABS AM & QHS
Sennosides 2 tabs taken the morning before and 2 tabs taken the evening before the colonoscopy.
干预措施: Sennosides (Drug)
结局指标
主要结局
Bowel movements, as measured by patient diary
时间窗: 2 days
The primary outcome of this pilot study is the number of bowel movements. Patients will record the timing and number of bowel motions produced.
次要结局
- Colon cleansing, as measured by The Ottawa Scale and Aronchick Bowel Cleansing Scale(2 days)
- Tolerability, as measured by patient questionnaire(2 days)
研究者
Dr. Lawrence Hookey
Principal Investigator
Queen's University