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

NCT ID: NCT01916564

Last Updated: 2013-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-03-31

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.

Conditions

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Bowel Preparation for Morning Colonoscopy

Keywords

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Bowel preparation Morning colonoscopy Split-dose Same-morning whole-dose Reduced-volume PEG-ELS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Same-morning whole-dose

2-L PEG-ELS between 5 a.m. and 6 a.m. on the day of colonoscopy

Group Type ACTIVE_COMPARATOR

Same-morning whole-dose

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Split-dose

Intervention Type OTHER

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

Interventions

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Split-dose

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

Intervention Type OTHER

Same-morning whole-dose

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Chan Wah Kheong

Senior Lecturer and Consultant Gastroneterologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wah Kheong Chan

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

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Endoscocpy Unit, University of Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

References

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Chan WK, Azmi N, Mahadeva S, Goh KL. Split-dose vs same-day reduced-volume polyethylene glycol electrolyte lavage solution for morning colonoscopy. World J Gastroenterol. 2014 Oct 21;20(39):14488-94. doi: 10.3748/wjg.v20.i39.14488.

Reference Type DERIVED
PMID: 25339836 (View on PubMed)

Other Identifiers

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SplitAMBPrep

Identifier Type: -

Identifier Source: org_study_id