Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children
Tracking Information | |||||
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First Received Date ICMJE | January 13, 2012 | ||||
Last Updated Date | January 23, 2012 | ||||
Start Date ICMJE | September 2010 | ||||
Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01518790 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children | ||||
Official Title ICMJE | Evaluation of Short Course, Single-dose Polyethylene Glycol (PEG) 3350 Regimen for Colonoscopy Bowel Preparation in Children | ||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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Condition ICMJE | Colonoscopy | ||||
Intervention ICMJE | 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 |
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Study Arm (s) | Experimental: Polyethylene glycol 3350
Intervention: Drug: polyethylene glycol 3350 |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 50 | ||||
Completion Date | August 2011 | ||||
Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 8 Years to 18 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01518790 | ||||
Other Study ID Numbers ICMJE | 353750 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Walter Reed National Military Medical Center | ||||
Study Sponsor ICMJE | Walter Reed National Military Medical Center | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Walter Reed National Military Medical Center | ||||
Verification Date | January 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |