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

Bowel Preparation Clinical Trial

Official title:

One-Day Bowel Preparation With Polyethylene Glycol 3350 (Miralax®) is as Effective and Safe as Three-Day Preparation for Colonoscopy in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174497
• Other study ID #: OMB No 0925-0586
• Status: Completed
• Phase: N/A
• First received: May 21, 2014
• Last updated: June 23, 2014
• Start date: February 2008
• Est. completion date: June 2010

Study information

• Verified date: June 2014
• Source: St. John Health System, Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 21 Years

Eligibility

Inclusion Criteria:

• Pediatric Patients referred for an outpatient colonoscopy

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bowel Preparation
• Pediatric Colonoscopy

Locations

Country	Name	City	State
United States	St. John Hospital and Medical Center	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
St. John Health System, Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of a one day versus a three day colonoscopy preparation in a pediatric population	The Safety of the different preparations was documented by monitoring serum electrolytes before and after the preparation.	02/08-06/10 (28 months)	Yes
Secondary	Tolerability of a one day versus a three day colonoscopy preparation in a pediatric population	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	02/08-06/10 (28 months)	No