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

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.

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Key information

Conditions

Bowel Preparation Pediatric Colonoscopy

Age range

2 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pediatric Patients referred for an outpatient colonoscopy

Exclusion criteria

None

Treatment and study plan

Primary outcomes

Safety of a one day versus a three day colonoscopy preparation in a pediatric population

Time frame: 02/08-06/10 (28 months)

The Safety of the different preparations was documented by monitoring serum electrolytes before and after the preparation.

Secondary outcomes

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

St. John Health System, Michigan

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Jun 25, 2014
Registry last updated: Jun 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed