Comparing 2L Bi-Pegyte to 4L PegLyte Regiments for Outpatient Colonic Preparation

Oral 2L Bi-PegLyte Versus 4L PegLyte Regimen for Outpatient Colonic Preparation: A Randomized, Non-Inferiority Open Trial

The investigators wish to compare the efficacy and patient tolerability of a preparation consisting of 2L Bi-Peglyte plus 15mg of bisacodyl vs the standard preparation of 4L Peglyte. The investigators hypothesize that 2L Bi-Peglyte with 15mg bisacodyl will show higher efficacy and tolerability.

Study Overview

• Status: Completed
• Conditions: Efficacy of Bowel Preparation; Ease of Bowel Preparation and Patient Tolerability
• Intervention / Treatment: Drug: Standard Bowel Prep; Drug: 2L Bi-Peglyte Bowel Prep

• Study Type: Interventional
• Enrollment (Actual): 318
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z1Y6
      • St. Paul's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 19 or older
• Outpatient colonoscopy

Exclusion Criteria:

• constipation

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Boston Bowel Preparation Scale between the two groups	This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared between the two groups.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the number of participants who develop distress symptoms from bowel prep (and the type) between the two groups	Number of participants who develop distress symptoms from bowel prep, and the type of distress symptoms will be compared between the two groups	20 hours
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.	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.	20

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Robert A Enns, MD, The University of British Columbia

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: July 14, 2011
• First Submitted That Met QC Criteria: July 18, 2011
• First Posted (Estimate): July 20, 2011

Study Record Updates

• Last Update Posted (Estimate): September 19, 2013
• Last Update Submitted That Met QC Criteria: September 17, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Patient comfort; Bowel Preparation; Bi-Peglyte
• Other Study ID Numbers: H11-00688