Comparing 4L Golytely to 2L Golytely With 15mg Bisacodyl Regimens for Inpatient 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 Golytely (PEG + electrolytes) plus 15mg of bisacodyl vs the standard preparation of 4L Golytely. The investigators hypothesize that 2L Golytely with 15mg bisacodyl will show similar bowel cleansing efficacy while offering better tolerability.

Official Title
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2L Golytely and Oral Bisacodyl 15 mg Versus 4L Golytely Regimen for Inpatient Colonoscopy Bowel Preparation: A Randomized, Non-Inferiority Open Trial

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: Standard Bowel Prep
* Drug: 2L Golytely/bisacodyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatients undergoing colonoscopy Age 19 or over Exclusion Criteria: Unable to provide informed consent Patients with constipation Patients with suspected bowel obstruction or severe inflammatory bowel disease Same-day colonoscopy Intensive/critical care patient History of colorectal resection

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2L Golytely/15mg bisacodyl<br>Subjects will be asked to take 2L Golytely + 15mg bisacodyl for bowel prep the day before colonoscopy. | Drug: 2L Golytely/bisacodyl<br>* Subjects will be asked to take 2L Golytely and 15mg bisacodyl the day prior to procedure.<br>|
| Active Comparator: Standard bowel prep<br>Subject will receive standard bowel prep (4L Golytely) prior to colonoscopy. | Drug: Standard Bowel Prep<br>* Subjects will be asked to take 4L of Golytely 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 & Ottawa Bowel Preparation Scale between the two groups | These are established rating scales to evaluate the quality of bowel prep. The ratings will be compared between the two groups. | 30min | 

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 | 20hours | 
| 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. | 20hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, bowel preparation, Golytely