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

Bowel Preparation for Morning Colonoscopy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01916564
• Other study ID #: SplitAMBPrep
• Status: Completed
• Phase: N/A
• First received: July 26, 2013
• Last updated: August 1, 2013
• Start date: August 2012
• Est. completion date: March 2013

Study information

• Verified date: August 2013
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Bowel Preparation for Morning Colonoscopy

Intervention

Other:
• 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
• 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

Locations

Country	Name	City	State
Malaysia	Endoscocpy Unit, University of Malaya Medical Centre	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No