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The investigators propose to conduct a prospective study of a widely used bowel preparation regimen (polyethylene glycol 3350 + a sports drink) on pediatric patients who undergo a colonoscopy performed by the pediatric gastroenterology service at WRAMC/WRNMMC between 1 Sep 2010 and 31 Dec 2011. This study will involve the following: determine efficacy of the cleanout, assess tolerability and acceptance of the regimen, determine an appropriate duration to complete the regimen and assess for any electrolyte changes or side effects.
Purpose: It is hoped that by determining acceptability, safety and efficacy of this widely used short course, single-dose bowel preparation regimen, pediatric gastroenterologist can have a standardized bowel preparation for colonoscopy that will be acceptable to pediatric patients and their parents.
Research Design: This study is a prospective medication trial. It will utilize laboratory data to detect any electrolyte changes, a patient questionnaire to assess an acceptable duration, tolerance and side effects of the regimen. Efficacy of the cleanout will be assessed using a published standardized bowel preparation scale by the endoscopist at the completion of the colonoscopy.
Methodology /Technical Approach (including the number of subjects to be studied.): We estimate that 50 patients aged 8-18 years old military dependents who are undergoing a colonoscopy by the Pediatric Gastroenterology service at WRAMC/WRNMMC will be enrolled in the study between 1 Sep 2010 and 31 Dec 2011.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyethylene glycol 3350 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polyethylene glycol 3350 | Drug | PEG 3350 (238 grams) mixed with 1.9 L (64 oz) of Gatorade, given in 8 oz increments every 15-30 minutes until complete starting at 18:00 on day prior to colonoscopy (max time to completion 6 hours). |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Cleanout | Efficacy of cleanout utilizing Boston bowel preparation scale, completed by endoscopy fellow and staff at the end of the colonoscopy done within 10-18 hours after completion of the cleanout. | At the end of the colonoscopy within 10-18 hours of completing the cleanout |
| Measure | Description | Time Frame |
|---|---|---|
| Electrolyte changes assessing basic metabolic profiles pre/post cleanout | BMP will be obtain within 30 days of cleanout and on the day of the colonoscopy at the time of IV insertion for anesthesia. | 30 days prior to 1 day after cleanout |
| Patient/parent satisfaction/tolerability/side effects utilizing questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mazen I Abbas, DO, MPH | Walter Reed National Military Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20814 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22744195 | Derived | Abbas MI, Nylund CM, Bruch CJ, Nazareno LG, Rogers PL. Prospective evaluation of 1-day polyethylene glycol-3350 bowel preparation regimen in children. J Pediatr Gastroenterol Nutr. 2013 Feb;56(2):220-4. doi: 10.1097/MPG.0b013e31826630fc. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 26, 2016 | |
| Reset | Jun 2, 2016 | |
| Release | Oct 31, 2016 | |
| Reset | Dec 22, 2016 | |
| Release | May 10, 2017 | |
| Reset | Jun 8, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 26, 2016 | Jun 2, 2016 | |||
| Oct 31, 2016 |
| ID | Term |
|---|---|
| C000595212 | polyethylene glycol 3350 |
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|
Parents or patient fill out questionnaire on day of the colonoscopy |
| 1 day after cleanout |
| Dec 22, 2016 |
| May 10, 2017 | Jun 8, 2017 |