A Study Comparing PEG-3350 (Miralax) and Gatorade With PEG-ELS (Golytely) for Bowel Preparation Prior to Colonoscopy

Study Overview
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Brief Summary
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The purpose of this study to to see how well Miralax (PEG-3350) and Gatorade cleans the colon before a colonoscopy and how easy it is to take compared to Golytely (PEG-ELS) bowel preparation solution. Another purpose is to see if taking half of the bowel preparation solution on the evening before the colonoscopy and half on the morning of the colonoscopy will result in a cleaner colon than taking all of the bowel preparation solution on the evening before.

Official Title
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A Randomized, Controlled, Single-Blind Study Comparing the Efficacy, Tolerability and Safety of PEG-3350 (Miralax) and Gatorade With PEG-ELS (Golytely) for Bowel Preparation Prior to Colonoscopy

Conditions
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Bowel Preparation for Colonoscopy

Intervention / Treatment
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* Drug: PEG-ELS (Golytely)
* Drug: PEG-ELS (Golytely)
* Drug: Miralax mixed with Gatorade
* Drug: Miralax


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years in age Undergoing full colonoscopy for colorectal cancer screening or colon polyp/cancer surveillance or other diagnostic purpose Exclusion Criteria: Allergic to polyethylene glycol Pregnant or lactating Baseline abnormalities of relevant serum electrolytes including Sodium, Potassium, Calcium, Magnesium and phosphorus Congestive Heart Failure NY Heart Assn, Grades III and IV Liver Cirrhosis Childs Pugh Class B or C Serum Creatinine greater than 1.5 Previous alimentary tract surgery Ongoing symptoms of abdominal pain, bloating, nausea or constipation Ileus, suspected bowel obstruction, toxic colitis or megacolon, severe ulcerative colitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>4L of PEG-ELS (Golytely) consumed on the evening before colonoscopy | Drug: PEG-ELS (Golytely)<br>* 4L consumed evening before colonoscopy<br>|
| Experimental: Group 2<br>2L of PEG-ELS (Golytely) consumed on the evening before and 2L consumed on the morning of colonoscopy | Drug: PEG-ELS (Golytely)<br>* 2L consumed on the evening before and 2L consumed on the morning of Colonoscopy<br>|
| Experimental: Group 3<br>238g of PEG-3350 mixed with 2L of Gatorade | Drug: Miralax mixed with Gatorade<br>* 238g of PEG-3350 (Miralax) mixed with 2L of Gatorade consumed on the evening before colonoscopy<br>|
| Experimental: Group 4<br>1L of PEG-3350 + Gatorade | Drug: Miralax<br>* 1L of PEG-3350 + Gatorade consumed on the evening before and 1L of PEG-3350 + Gatorade consumed on the morning of Colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale |  | two years | 

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