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临床试验/NCT01916564
NCT01916564已完成不适用

Efficacy and Tolerability of Split-dose Versus Same-day Administration of Reduced-volume PEG-ELS Plus Bisacodyl for Morning Colonoscopy: a Randomised Trial

University of Malaya1 个研究点 分布在 1 个国家目标入组 303 人开始时间: 2012年8月1日最近更新:
适应症
干预措施

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chan Wah Kheong

Senior Lecturer and Consultant Gastroneterologist

University of Malaya

研究点 (1)

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