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

Not Applicable

Completed

• Conditions: Efficacy of Bowel Preparation; Ease of Bowel Preparation and Patient Tolerability
• Interventions: Drug: Standard Bowel Prep; Drug: 2L Bi-Peglyte Bowel Prep

• Registration Number: NCT01398020
• Lead Sponsor: University of British Columbia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-20
• Primary Completion: 2012-09
• Status Verified: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-09-17
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 318

Inclusion Criteria

• Age 19 or older
• Outpatient colonoscopy

Exclusion Criteria

• constipation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard bowel prep	Standard Bowel Prep	Subject will receive standard bowel prep prior to colonoscopy.
2L Bi-Peglyte	2L Bi-Peglyte Bowel Prep	Subjects will be asked to take 2L Bi-Peglyte + 15mg bisacodyl for bowel prep the day before colonoscopy.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Difference in the number of participants who develop distress symptoms from bowel prep (and the type) between the two groups	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.	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.

Trial Locations

Locations (1)

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada