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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Water-Electrolyte Imbalance

Intervention / Treatment
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* Drug: polyethylene glycol powder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 |