2L Oral Bi-PegLyte Versus 2L Oral MoviPrep Regimen for Outpatient Colonic Preparation

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01865916
First received: May 13, 2013
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

This study is a randomized, controlled, single centre, endoscopist-blinded non-inferiority trial. The purpose of our study is to determine if using a 2-litre mixture in combination with vitamin C is better than using 2 litres of mixture with bisacodyl tablets. Two-litre PegLyte based preparations with an added laxative agent are commonly used for colonoscopies in outpatient settings. If the investigators discover that a 2-litre mixture with either the tablets or the ascorbic acid work better, future patients undergoing colonoscopy will be able to experience fewer side effects and be less troubled by the preparation while still allowing a good view of the colon.


Condition Intervention Phase
Colonoscopy
Drug: Polyethylene Glycol (PEG) and 15 mg Bisacodyl
Drug: Polyethylene Glycol (PEG) + ascorbic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 2L Oral Bi-PegLyte Versus 2L Oral MoviPrep Regimen for Outpatient Colonic Preparation: A Randomized, Non-Inferiority Open Trial

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Bowel cleansing efficacy as rated by a Boston Bowel Preparation Scale score of greater than 8 [ Time Frame: 20 hours ] [ Designated as safety issue: No ]
    The BBPS is a relatively new, validated scoring system assessing cleanliness of three segments of the colon (left colon, transverse, and right colon). The total is a 10 point scale (0-9) that grades each segment of the colon from 0-3. A segment score of 0 describes: 'unprepared colon segment with mucosa not well seen due to solid stool that cannot be cleared'. Segment score 1: 'portion of mucosa of the colon segment seen, but other areas of the colon are not well seen due to staining, residual stool and/or opaque liquid'. Segment score 2: 'minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well'. Segment score 3: 'entire mucosa of the colon segment seen well with no residual staining, small fragments of stool and/or opaque liquid'. In this study, we define an excellent equivalent BBPS score as 8 or 9. Scores of 7 or above are generally felt to provide a good visualization of the colon.


Secondary Outcome Measures:
  • Patient tolerability to each 2L product [ Time Frame: 20 hours ] [ Designated as safety issue: No ]
    Our secondary outcome is patient tolerability to each 2L product based on a ten-question survey. The questionnaire basically asks about patient experience in terms of charateristic taste of bowel prep, volume intake, any distressing signs and symptoms, compliance to bowel preparation solution assigned to subjects using a Likert scale. The number of participants in each level will subsequently be quantified (n,%) and compared between the two groups


Estimated Enrollment: 278
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2 Liters Bi-Peglyte
Subjects will be asked to take split dose of 2 Liters PEG + 15mg bisacodyl for bowel preparation the day before colonoscopy.
Drug: Polyethylene Glycol (PEG) and 15 mg Bisacodyl
Subjects will be asked to take split dose of 2L PEG and 3 tablets of 5 mg Bisacodyl
Other Name: Bi-Peglyte
Experimental: 2 Liters Moviprep
Subject will be asked to take split dose of 2 Liters PEG + ascorbic acid for bowel preparation the day before colonoscopy
Drug: Polyethylene Glycol (PEG) + ascorbic acid
Subjects will be asked to take split dose of 2L PEG and vitamin C
Other Name: Moviprep

Detailed Description:

All adults (≥ 19 yrs of age) who are referred to St. Paul's Hospital for outpatient colonoscopy will be included in our study. Exclusion criteria included those with constipation, suspected or known small bowel obstruction, severe inflammatory bowel disease, and any history of colonic resection. 278 consecutive eligible patients will be randomized to one of two bowel preparations through the use of concealed allocation by a scheduling assistant (blinded) in a one-to-one allocation ratio. Bowel preparations included: (i) 2 L of MoviPrep (2 L PEG 3350 electrolyte solution + ascorbic acid) or (ii) Bi-Peglyte (2 L PEG 3350 electrolyte solution and 15mg bisacodyl). Patients in both arms will be instructed to adhere to a clear liquid diet commensing 24 hours prior to scheduled colonoscopy in addition to their remaining bowel preparation.

The investigators will not have access to the randomization envelopes and the randomized bowel preparation will be stored within the medical record that will not be accessible by the endoscopist. The endoscopists can break blinding and access the bowel prep given when medically necessary.

At the time of their procedure check-in, written consent will be confirmed and patients will respond to a brief survey assessing patient tolerance. All colonoscopies will be performed under conscious sedation by an experienced endoscopist. Endoscopists will be blinded to the bowel preparation until the completion of the study. We will use the Boston Bowel Preparation Scale (BBPS) and Ottawa Bowel Preparation Scale (OBPS) to assess efficacy in bowel preparation.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All adults (≥ 19 years of age) who are referred to St. Paul's Hospital for outpatient colonoscopy will be included in our study.

Exclusion Criteria:

  • those with constipation,
  • suspected or known small bowel obstruction,
  • severe inflammatory bowel disease, and
  • any history of colonic resection.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01865916

Contacts
Contact: Cherry E Galorport 604-806-9440 cgalorport@gmail.com
Contact: Andrew Round 604-688-6332 ext 222 drewround@gmail.com

Locations
Canada, British Columbia
GI Clinic, St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 2K5
Contact: Cherry E Galorport    604-806-9440    cgalorport@gmail.com   
Contact: Andrew Round    604-688-6332 ext 222    drewround@gmail.com   
Principal Investigator: Robert Enns, MD         
Sub-Investigator: Mayur Brahmania, MD         
Sub-Investigator: Andrew Round         
Sub-Investigator: Cherry Galorport         
Sub-Investigator: Jennifer Telford, MD         
Sub-Investigator: Hinhin Ko, MD         
Sub-Investigator: Brian Bressler, MD         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Robert Enns, MD, FRCP University of British Columbia
  More Information

Publications:

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01865916     History of Changes
Other Study ID Numbers: H13-00502
Study First Received: May 13, 2013
Last Updated: June 16, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Ascorbic Acid
Bisacodyl
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances
Cathartics
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014