Evaluation of One-day Polyethylene Glycol Powder Solution for Colonoscopy in Children

NCT01626040 | Completed

• 1 other identifier: 12-008643
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effects of current standard of care Polyethylene Gylcol powder (PEG-P)colonoscopy preparation on a patient's serum electrolytes, tolerance of the prep, and how well the bowel is cleansed. The primary aim is to determine the proportion of patients with clinically significant serum electrolyte abnormalities at the time of colonoscopy and how well the prep is tolerated. Secondary objectives include: 1) how well the bowel is cleansed with this preparation, and 2) to determine the most effective way to communicate instructions about the bowel preparation with the child and family.

Conditions

Water-Electrolyte Imbalance

Outcome Measures

Primary Outcomes (2)

• electrolyte disturbances

  the proportion of patients with clinically significant serum electrolyte abnormalities at the time of colonoscopy

  at the time of colonoscopy

• PEG-P preparation tolerance

  Responses to a questionnaire regarding the tolerance of the PEG-P prep will be recorded

  at the time of colonoscopy

Secondary Outcomes (2)

• Colonoscopy preparation efficacy

  at the time of colonoscopy

• Effective communication

  at the time of colonoscopy

Study Arms (1)

PEG-P prep

Children taking the one day polyethylene glycol powder preparation for outpatient colonoscopy

Drug: polyethylene glycol powder

Interventions

polyethylene glycol powder DRUG

A single group of children taking a polyethylene glycol powder preparation, dosage determined by patient weight, taken in one dose the day before colonoscopy

PEG-P prep

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

children undergoing outpatient colonoscopy

You may qualify if:

• Subjects age 1 - 18 years
• patients receiving standard of care dosing for polyethylene glycol powder
• patients who had electrolyte results within the last 60 days of enrollment
• parental / guardian permission (informed consent)

You may not qualify if:

• Patients on the GI inpatient or consult service
• Weight less than 10 kg
• Pregnant or lactating females
• Non-English speaking patient or parent
• \) Parents/guardians or subjects who, in the opinion of the Investigator/Study team, may be non-compliant with study schedules or procedures

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

No biospecimens are to be retained

MeSH Terms

Conditions

Water-Electrolyte Imbalance

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Petar Mamula, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: June 22, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 17, 2014

Record last verified: 2014-01

Locations

US (1)