- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01518790
Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children
Evaluation of Short Course, Single-dose Polyethylene Glycol (PEG) 3350 Regimen for Colonoscopy Bowel Preparation in Children
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20814
- Walter Reed National Military Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At the end of the colonoscopy within 10-18 hours of completing the cleanout
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 days prior to 1 day after cleanout
|
Patient/parent satisfaction/tolerability/side effects utilizing questionnaire
Time Frame: 1 day after cleanout
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Parents or patient fill out questionnaire on day of the colonoscopy
|
1 day after cleanout
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mazen I Abbas, DO, MPH, Walter Reed National Military Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 353750
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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