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

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.

Study Overview

• Status: Completed
• Conditions: Water-Electrolyte Imbalance
• Intervention / Treatment: Drug: polyethylene glycol powder

Detailed Description

Design is prospective, descriptive observational study involving a single clinical encounter in the Endoscopy suite at CHOP Main at the time of colonoscopy. Patients prescribed the standard of care dosage for PEG-P by their primary gastroenterologist are considered for this study. Study procedures include collection of data from patients that are prescribed the PEG-P dose. In order to evaluate the safety, tolerability, and adherence to PEG-P bowel preparation, data collections include the following: review of medical records, tracking of communication from subjects/parents, blood draw, questionnaire and quality of prep will be assessed. Questionnaire results will be obtained at the initial and only visit. Patients will be given a questionnaire prior to colonoscopy to rate symptoms, ease of preparation and to rate the effectiveness of communication about the preparation. On the day of colonoscopy, prior to the procedure, patients will have an IV placed per standard procedure. At the time of IV placement, a basic metabolic panel and serum magnesium and phosphorus levels will be drawn through the IV for assessment of electrolyte abnormalities. Serum glucose will be captured from medical records as this is collected with standard of care. Patient/parents will grade the preparation tolerance filling out a questionnaire prior to colonoscopy. During colonoscopy, the endoscopist will grade the quality of preparation on a validated residual stool survey (Aronchick scale).

• Study Type: Observational
• Enrollment (Actual): 178

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

children undergoing outpatient colonoscopy

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PEG-P prep; Children taking the one day polyethylene glycol powder preparation for outpatient colonoscopy	Drug: polyethylene glycol powder; A single group of children taking a polyethylene glycol powder preparation, dosage determined by patient weight, taken in one dose the day before colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colonoscopy preparation efficacy	To assess the proportion of patients that have excellent or good quality preparation as scored by a validated residual stool survey called the Aronchick scale	at the time of colonoscopy
Effective communication	Effectiveness of communication strategy about the prep and availability of staff to address questions reported by parents will be summarized	at the time of colonoscopy

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: June 20, 2012
• First Submitted That Met QC Criteria: June 21, 2012
• First Posted (Estimate): June 22, 2012

Study Record Updates

• Last Update Posted (Estimate): January 17, 2014
• Last Update Submitted That Met QC Criteria: January 16, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance
• Other Study ID Numbers: 12-008643