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Prior to colonoscopies, the colon is cleansed using a laxative. Golytely is approved by the FDA for this purpose. Another laxative, called MiraLax, is approved by the FDA to relieve constipation, but it is not approved specifically for preparation for a colonoscopy. Nonetheless, it is commonly used in clinical practice for this purpose, just as is Golytely. The purpose of this study is to compare Golytely and MiraLax in two ways: to see whether one is better tolerated by patients than the other and to see whether one more effectively cleanses the bowel than the other. The investigators' hypothesis is that these 2 bowel preparation methods are equally effective in bowel cleansing, but that patients prefer Miralax to Golytely.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Golytely | Active Comparator | 216 patients at random will provided a prescription for the standard 4 L golytely preparation as the bowel cleanser for their colonoscopy |
|
| MiraLax | Experimental | 216 patients will be randomized to take 238 gm of miralax mixed with 64 oz of gatorade for their bowel cleanser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golytely (polyethylene glycol) | Drug | 4 L of golytely, in split dosing. If the patient has a morning colonoscopy, they will take 2 L of golytely over 2 hours the morning prior to their procedure and repeat this at 6 pm the night prior to their procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| bowel cleanliness as rated by the boston bowel prep survey | measured at the time of colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| patient tolerability | measured at check in to colonoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Glenn Eisen, MD, MPH | Contact | 503-494-8311 | eiseng@ohsu.edu | |
| Brintha K Enestvedt, MD, MBA | Contact | 503-494-8311 | 11859 | enestveb@ohsu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Sciences University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21083586 | Derived | Enestvedt BK, Fennerty MB, Eisen GM. Randomised clinical trial: MiraLAX vs. Golytely - a controlled study of efficacy and patient tolerability in bowel preparation for colonoscopy. Aliment Pharmacol Ther. 2011 Jan;33(1):33-40. doi: 10.1111/j.1365-2036.2010.04493.x. Epub 2010 Oct 25. |
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| ID | Term |
|---|---|
| C033608 | Golytely |
| D011092 | Polyethylene Glycols |
| C000595212 | polyethylene glycol 3350 |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| MiraLax (polyethylene glycol 3350) | Drug | 238 gm of MiraLax mixed in 64 oz of Gatorade, to be consumed in split dosing the day prior to scheduled colonoscopy. |
|
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |