One-Day Versus Three-Day Bowel Preparation for Colonoscopy in Children

Completed

• Conditions: Pediatric Colonoscopy; Bowel Preparation

• Registration Number: NCT02174497
• Lead Sponsor: St. John Health System, Michigan

Brief Summary

This was a blinded study conducted on the efficacy and safety of a one-day versus a three-day bowel preparation in a pediatric population. Limited data is available in this regard, and this study supports the use of a one-day bowel preparation, as this is both safe and effective.

Detailed Description

Colonoscopy in children and young adults is performed by gastroenterologists for a variety of indications, including but not limited to evaluation of rectal bleeding, chronic diarrhea, family history of polyposis syndromes and surveillance for colon cancer in patients with inflammatory bowel disease. A successful bowel preparation that enables clear visualization of the intestinal mucosa is essential to diagnose and treat the underlying pathology. Currently, gastroenterologists use a variety of colon cleansing preparations, but Polyethylene Glycol (PEG) 3350 given for three to four days appears to be standard. Though it is well tolerated, safe and effective the duration of preparation may cause disruption to the routine and missed school days. To date, there is limited data that shows efficacy of a shorter duration of bowel preparation with PEG. This study aims to compare the efficacy and safety of a one-day preparation with that of a three-day preparation with PEG 3350 as preparation for colonoscopy in children and young adults.

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2014-05-21
• Status Verified: 2014-06
• Study First Submitted QC: 2014-06-23
• Last Update Submitted: 2014-06-23
• Study First Posted: 2014-06-25
• Last Update Posted: 2014-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Pediatric Patients referred for an outpatient colonoscopy

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of a one day versus a three day colonoscopy preparation in a pediatric population	02/08-06/10 (28 months)	The Safety of the different preparations was documented by monitoring serum electrolytes before and after the preparation.

Secondary Outcome Measures

Name	Time	Method
Tolerability of a one day versus a three day colonoscopy preparation in a pediatric population	02/08-06/10 (28 months)	The tolerability was documented by monitoring the patient's clinical ability to consume the entire colonoscopy preparation without abdominal pain, nausea or vomiting. Furthermore, this was objectively documented by monitoring and recording the following parameters: Ease of Administration, Compliance, Willingness to take again

Trial Locations

Locations (1)

St. John Hospital and Medical Center; 🇺🇸 Detroit, Michigan, United States