Clinical trial NCT01916564: Split-dose Versus Same-day Reduced-volume PEG-ELS Plus Bisacodyl for Morning Colonoscopy
Official title: Efficacy and Tolerability of Split-dose Versus Same-day Administration of Reduced-volume PEG-ELS Plus Bisacodyl for Morning Colonoscopy: a Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Preparation for Morning Colonoscopy
Keywords: Bowel preparation
Morning colonoscopy
Split-dose
Same-morning whole-dose
Reduced-volume PEG-ELS
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of bowel preparation
timeFrame: During the colonoscopy procedure itself which spans an average of 20 minutes
measure: Patient tolerability
timeFrame: The period from commencement of bowel preparation to the colonoscopy procedure itself which spans approximately 36 hours
Secondary outcomes:
measure: Technical aspects of colonoscopy
timeFrame: During the colonoscopy procedure itself which spans an average of 20 minutes
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Endoscocpy Unit, University of Malaya Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: University of Malaya
name: Wah Kheong Chan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.