Split-dose Versus Same-day Reduced-volume PEG-ELS Plus Bisacodyl for Morning Colonoscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Bowel Preparation for Morning Colonoscopy

Intervention / Treatment
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* Other: Split-dose
* Other: Same-morning whole-dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive adult patients undergoing morning outpatient colonoscopy at the Endoscopy Unit, University of Malaya Medical Centre Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Same-morning whole-dose<br>2-L PEG-ELS between 5 a.m. and 6 a.m. on the day of colonoscopy | Other: Same-morning whole-dose<br>* 2 tablets of bisacodyl 5 mg at 8 p.m. two days before colonoscopy Low fibre diet and 2 tablets of bisacodyl 5 mg at 8 p.m. on the day before colonoscopy 2-L PEG-ELS between 5 a.m. and 6 a.m. on the day of colonoscopy<br>|
| Active Comparator: Split-dose<br>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 | Other: Split-dose<br>* 2 tablets of bisacodyl 5 mg at 8 p.m. two days before colonoscopy Low fibre diet and 2 tablets of bisacodyl 5 mg at 8 p.m. on the day before colonoscopy 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of bowel preparation | Using the Boston Bowel Preparation Scale and an overall grading by the endoscopist | During the colonoscopy procedure itself which spans an average of 20 minutes | 
| Patient tolerability | Using the questionnaire by Aronchick and colleagues and an ordinal five-value Likert scale question on comfort level during bowel preparation | The period from commencement of bowel preparation to the colonoscopy procedure itself which spans approximately 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical aspects of colonoscopy | Cecal intubation rate, cecal intubation, withdrawal and colonoscopy times, adenoma detection rate and number of adenoma detected are recorded | During the colonoscopy procedure itself which spans an average of 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowel preparation, Morning colonoscopy, Split-dose, Same-morning whole-dose, Reduced-volume PEG-ELS