2L Oral Bi-PegLyte Versus 2L Oral MoviPrep Regimen for Outpatient Colonic Preparation
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|ClinicalTrials.gov Identifier: NCT01865916|
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : June 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colonoscopy||Drug: Polyethylene Glycol (PEG) and 15 mg Bisacodyl Drug: Polyethylene Glycol (PEG) + ascorbic acid||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||309 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||2L Oral Bi-PegLyte Versus 2L Oral MoviPrep Regimen for Outpatient Colonic Preparation: A Randomized, Non-Inferiority Open Trial|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||February 2016|
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
- Bowel cleansing efficacy as rated by a Boston Bowel Preparation Scale score of greater than 8 [ Time Frame: 20 hours ]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.
- Patient tolerability to each 2L product [ Time Frame: 20 hours ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865916
|Canada, British Columbia|
|GI Clinic, St. Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z 2K5|
|Principal Investigator:||Robert Enns, MD, FRCP||University of British Columbia|