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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier:
NCT01518790
First received: January 13, 2012
Last updated: January 23, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Colonoscopy
Drug: polyethylene glycol 3350

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Short Course, Single-dose Polyethylene Glycol (PEG) 3350 Regimen for Colonoscopy Bowel Preparation in Children

Resource links provided by NLM:


Further study details as provided by Walter Reed National Military Medical Center:

Primary Outcome Measures:
  • Efficacy of Cleanout [ Time Frame: At the end of the colonoscopy within 10-18 hours of completing the cleanout ] [ Designated as safety issue: No ]
    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:
  • Electrolyte changes assessing basic metabolic profiles pre/post cleanout [ Time Frame: 30 days prior to 1 day after cleanout ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Parents or patient fill out questionnaire on day of the colonoscopy


Enrollment: 50
Study Start Date: September 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518790

Locations
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814
Sponsors and Collaborators
Walter Reed National Military Medical Center
Investigators
Principal Investigator: Mazen I Abbas, DO, MPH Walter Reed National Military Medical Center
  More Information

No publications provided by Walter Reed National Military Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT01518790     History of Changes
Other Study ID Numbers: 353750
Study First Received: January 13, 2012
Last Updated: January 23, 2012
Health Authority: United States: Federal Government

Keywords provided by Walter Reed National Military Medical Center:
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.

ClinicalTrials.gov processed this record on September 18, 2014