Clinical trial NCT01518790: Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children
Official title: Evaluation of Short Course, Single-dose Polyethylene Glycol (PEG) 3350 Regimen for Colonoscopy Bowel Preparation in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Keywords: PEG 3350
boston bowel preparation scale
colonoscopy cleanout
bowel preparation
miralax
gatorade
cleanout efficacy
Focus of study is efficacy of PEG 3350 cleanout for improving diagnostic yield of colonoscopy.
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
First posted: 2012-01-26
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male and female DEERS-eligible dependent military health care beneficiaries age 8 to 18 years old evaluated by Pediatric Gastroenterology service at WRAMC and are scheduled to undergo a colonoscopy between 1 Sep 2010 - 31 Dec 2011 and do not meet exclusion criteria.

Exclusion Criteria:

* Age less than 8 years or greater than 18 at time of procedure
* Colonic surgery including hemicolectomy, colectomy, ileostomy, or multiple abdominal surgeries.
* Oral aversion or other feeding disorder.
* Inability to drink large amount of liquids.
* Aspiration risk.
* Renal disease or pre-cleanout electrolytes outside normal range.
* Significant cardiovascular disease.
* Allergy to food coloring or polyethylene glycol 3350.
* Inpatient or emergency colonoscopy.
* Current nasogastric tube in place.
* Known Pregnancy. Urine pregnancy test will only be completed on day of colonoscopy for all females age 14 and older per current standard anesthesia protocols. There have been no known reported animal or human studies that report the fetal effects of using polyethylene glycol. Per FDA, it is labeled as a category C drug in pregnancy. However, two studies , have reported successful treatment of constipation during pregnancy using polyethylene glycol solutions and did not find any significant effects or safety issues

Primary outcomes:
measure: Efficacy of Cleanout
timeFrame: At the end of the colonoscopy within 10-18 hours of completing the cleanout
Secondary outcomes:
measure: Electrolyte changes assessing basic metabolic profiles pre/post cleanout
timeFrame: 30 days prior to 1 day after cleanout
measure: Patient/parent satisfaction/tolerability/side effects utilizing questionnaire
timeFrame: 1 day after cleanout
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Walter Reed National Military Medical Center
name: Mazen I Abbas, DO, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.