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

Study Overview
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Brief Summary
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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.

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

Conditions
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Efficacy of Bowel Preparation, Ease of Bowel Preparation and Patient Tolerability

Intervention / Treatment
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* Drug: Standard Bowel Prep
* Drug: 2L Bi-Peglyte Bowel Prep


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 or older Outpatient colonoscopy Exclusion Criteria: constipation

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard bowel prep<br>Subject will receive standard bowel prep prior to colonoscopy. | Drug: Standard Bowel Prep<br>* Subjects will be asked to take 4L of Peglyte the day prior to procedure.<br>|
| Experimental: 2L Bi-Peglyte<br>Subjects will be asked to take 2L Bi-Peglyte + 15mg bisacodyl for bowel prep the day before colonoscopy. | Drug: 2L Bi-Peglyte Bowel Prep<br>* Subjects will be asked to take 2L Bi-Peglyte and 15mg bisacodyl the day prior to procedure.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowel Preparation, Patient comfort, Bi-Peglyte