NCT02174497

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
Last Updated

June 25, 2014

Status Verified

June 1, 2014

Enrollment Period

2.3 years

First QC Date

May 21, 2014

Last Update Submit

June 23, 2014

Conditions

Keywords

Pediatric ColonoscopyBowel PreparationSafetyTolerability

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Tolerability of a one day versus a three day colonoscopy preparation in a pediatric population

    02/08-06/10 (28 months)

Study Arms (2)

Control

Three day Bowel Preparation

Study Arm

One day Bowel Preparation

Eligibility Criteria

Age2 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children between 2 and 21 years of age undergoing elective colonoscopy were enrolled into the study.

You may qualify if:

  • Pediatric Patients referred for an outpatient colonoscopy

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Related Publications (1)

  • Sorser SA, Konanki V, Hursh A, Hagglund K, Lyons H. 1-day bowel preparation with polyethylene glycol 3350 is as effective and safe as a 3-day preparation for colonoscopy in children. BMC Res Notes. 2014 Sep 15;7:648. doi: 10.1186/1756-0500-7-648.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor of Pediatrics

Study Record Dates

First Submitted

May 21, 2014

First Posted

June 25, 2014

Study Start

February 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 25, 2014

Record last verified: 2014-06

Locations