Split-dose Versus Same-day Reduced-volume PEG-ELS Plus Bisacodyl for Morning Colonoscopy
August 1, 2013 updated by: Chan Wah Kheong, University of Malaya
Efficacy and Tolerability of Split-dose Versus Same-day Administration of Reduced-volume PEG-ELS Plus Bisacodyl for Morning Colonoscopy: a Randomised Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
303
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wilayah Persekutuan Kuala Lumpur
-
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 59100
- Endoscocpy Unit, University of Malaya Medical Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Same-morning whole-dose
2-L PEG-ELS between 5 a.m. and 6 a.m. on the day of colonoscopy
|
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 |
|
Active Comparator: 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
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of bowel preparation
Time Frame: 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
|
During the colonoscopy procedure itself which spans an average of 20 minutes
|
|
Patient tolerability
Time Frame: 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
|
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
Time Frame: During the colonoscopy procedure itself which spans an average of 20 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wah Kheong Chan, University of Malaya
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
July 26, 2013
First Submitted That Met QC Criteria
August 1, 2013
First Posted (Estimate)
August 5, 2013
Study Record Updates
Last Update Posted (Estimate)
August 5, 2013
Last Update Submitted That Met QC Criteria
August 1, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SplitAMBPrep
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