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Completed

NCT Number: NCT01916564

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

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.

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Key information

Conditions

Bowel Preparation for Morning Colonoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endoscocpy Unit, University of Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Split-dose

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

Same-morning whole-dose

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 5, 2013
Registry last updated
Aug 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.