Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children
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|ClinicalTrials.gov Identifier: NCT01518790|
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : February 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colonoscopy||Drug: polyethylene glycol 3350||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Short Course, Single-dose Polyethylene Glycol (PEG) 3350 Regimen for Colonoscopy Bowel Preparation in Children|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
|Experimental: Polyethylene glycol 3350||
Drug: polyethylene glycol 3350
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).
Other Name: Miralax
- Efficacy of Cleanout [ Time Frame: At the end of the colonoscopy within 10-18 hours of completing the 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.
- Electrolyte changes assessing basic metabolic profiles pre/post cleanout [ Time Frame: 30 days prior to 1 day after 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.
- Patient/parent satisfaction/tolerability/side effects utilizing questionnaire [ Time Frame: 1 day after cleanout ]Parents or patient fill out questionnaire on day of the colonoscopy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01518790
|United States, Maryland|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20814|
|Principal Investigator:||Mazen I Abbas, DO, MPH||Walter Reed National Military Medical Center|