An interventional study of polyethylene glycol 3350 in Colonoscopy, sponsored by Walter Reed National Military Medical Center. Completed at 1 site in United States. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2016-02-10.
Sponsored by Walter Reed National Military Medical Center · Not applicable, Interventional, and Diagnostic
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.
Walter Reed National Military Medical Center is the lead sponsor of 73 studies on the registry; 19 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Also known as: Miralax
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.
Time frame: At the end of the colonoscopy within 10-18 hours of completing the cleanout
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.
Time frame: 30 days prior to 1 day after cleanout
Patient/parent satisfaction/tolerability/side effects utilizing questionnaire
Parents or patient fill out questionnaire on day of the colonoscopy
Time frame: 1 day after cleanout
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Walter Reed National Military Medical Center