Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children

Not Applicable

Completed

• Conditions: Colonoscopy
• Interventions: Drug: polyethylene glycol 3350

• Registration Number: NCT01518790
• Lead Sponsor: Walter Reed National Military Medical Center

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.

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Study First Submitted: 2012-01-13
• Study First Submitted QC: 2012-01-23
• Study First Posted: 2012-01-26
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-09
• Last Update Posted: 2016-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Polyethylene glycol 3350	polyethylene glycol 3350	-

Primary Outcome Measures

Name	Time	Method
Efficacy of Cleanout	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.

Secondary Outcome Measures

Name	Time	Method
Electrolyte changes assessing basic metabolic profiles pre/post cleanout	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	1 day after cleanout	Parents or patient fill out questionnaire on day of the colonoscopy

Trial Locations

Locations (1)

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States