Completed

NCT Number: NCT01398020

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

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.

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Key information

Conditions

Efficacy of Bowel Preparation Ease of Bowel Preparation and Patient Tolerability

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 19 or older
Outpatient colonoscopy

Exclusion criteria

constipation

Treatment and study plan

Standard Bowel Prep

Drug

Subjects will be asked to take 4L of Peglyte the day prior to procedure.

2L Bi-Peglyte Bowel Prep

Drug

Subjects will be asked to take 2L Bi-Peglyte and 15mg bisacodyl the day prior to procedure.

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2013
First posted: Jul 20, 2011
Registry last updated: Sep 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.