Comparing 2L Bi-Pegyte to 4L PegLyte Regiments for Outpatient Colonic Preparation
|ClinicalTrials.gov Identifier: NCT01398020|
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : September 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Efficacy of Bowel Preparation Ease of Bowel Preparation and Patient Tolerability||Drug: Standard Bowel Prep Drug: 2L Bi-Peglyte Bowel Prep||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||318 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Oral 2L Bi-PegLyte Versus 4L PegLyte Regimen for Outpatient Colonic Preparation: A Randomized, Non-Inferiority Open Trial|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2013|
Active Comparator: Standard bowel prep
Subject will receive standard bowel prep prior to colonoscopy.
Drug: Standard Bowel Prep
Subjects will be asked to take 4L of Peglyte the day prior to procedure.
Experimental: 2L Bi-Peglyte
Subjects will be asked to take 2L Bi-Peglyte + 15mg bisacodyl for bowel prep the day before colonoscopy.
Drug: 2L Bi-Peglyte Bowel Prep
Subjects will be asked to take 2L Bi-Peglyte and 15mg bisacodyl the day prior to procedure.
- Difference in Boston Bowel Preparation Scale between the two groups [ Time Frame: 30 minutes ]This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared between the two groups.
- Difference in the number of participants who develop distress symptoms from bowel prep (and the type) between the two groups [ Time Frame: 20 hours ]Number of participants who develop distress symptoms from bowel prep, and the type of distress symptoms will be compared between the two groups
- Difference in the absolute number/percentage of participants in the two groups who find the bowel prep experience easy, acceptable, difficult, very difficult, or unable to complete. [ Time Frame: 20 ]Participants will be asked to rate their bowel prep experience (based on ease of use) on a Likert scale. The number of participants in each level will subsequently be quantified (n, %) and compared between the two groups.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398020
|Canada, British Columbia|
|St. Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z1Y6|
|Principal Investigator:||Robert A Enns, MD||The University of British Columbia|