Efficacy and Tolerability of Split-dose Versus Same-day Administration of Reduced-volume PEG-ELS Plus Bisacodyl for Morning Colonoscopy: a Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- Quality of bowel preparation
研究概览
简要总结
This study aims to compare split-dose vs. same-morning whole-dose of 2-litre PEG-ELS plus bisacodyl for bowel preparation for morning outpatient colonoscopy.
详细描述
A good bowel preparation regime is one that is not only effective in cleansing the colon but should be relatively small in volume and well-tolerated by patients with minimal adverse gastrointestinal symptoms. At our centre, reduced-volume 2-litre PEG-ELS plus bisacodyl and low fiber diet is used for bowel preparation for patients undergoing colonoscopy. Patients undergoing morning outpatient colonoscopy would normally ingest the PEG-ELS and bisacodyl the day before. This regime has been shown to be better tolerated by patients without compromising the quality of bowel preparation when compared with conventional 4-liter PEG-ELS. However, previous study on patient satisfaction found that nearly half of the patients attending the outpatient colonoscopy service at our centre were dissatisfied with the bowel preparation regime used. Of the seven items considered in the evaluation of patient satisfaction, comfort level during bowel preparation was the main cause of unfavorable responses. Moreover, a separate study using the same bowel preparation regime at our centre found a high percentage of poor quality bowel preparation, which was associated with increased technical difficulty and patient discomfort during colonoscopy. There was clearly a need for a better bowel preparation regime. Current literature suggests that either taking reduced-volume PEG-ELS on the same morning instead of the previous evening, or splitting the bowel preparation, would be better. However, whether the former or the latter is better, is unknown. The aim of our study was to compare the use of same-morning whole-dose reduced-volume PEG-ELS and split-dose reduced-volume PEG-ELS for bowel preparation for patients undergoing morning outpatient colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Consecutive adult patients undergoing morning outpatient colonoscopy at the Endoscopy Unit, University of Malaya Medical Centre
排除标准
- •In-patients, patients scheduled for afternoon colonoscopy, patients who used other bowel preparation regime than that assigned, patients who had incomplete examination not related o quality of bowel preparation e.g. obstructing tumour
研究组 & 干预措施
Same-morning whole-dose
2-L PEG-ELS between 5 a.m. and 6 a.m. on the day of colonoscopy
干预措施: Same-morning whole-dose (Other)
Split-dose
1-L PEG-ELS between 8 p.m. and 8.30 p.m. on the day before and 1-L PEG-ELS between 5.30 a.m. and 6 a.m. on the day of colonoscopy
干预措施: Split-dose (Other)
结局指标
主要结局
Quality of bowel preparation
时间窗: During the colonoscopy procedure itself which spans an average of 20 minutes
Using the Boston Bowel Preparation Scale and an overall grading by the endoscopist
Patient tolerability
时间窗: The period from commencement of bowel preparation to the colonoscopy procedure itself which spans approximately 36 hours
Using the questionnaire by Aronchick and colleagues and an ordinal five-value Likert scale question on comfort level during bowel preparation
次要结局
- Technical aspects of colonoscopy(During the colonoscopy procedure itself which spans an average of 20 minutes)
研究者
Chan Wah Kheong
Senior Lecturer and Consultant Gastroneterologist
University of Malaya
