Clinical trial NCT01626040: Evaluation of One-day Polyethylene Glycol Powder Solution for Colonoscopy in Children
Official title: Evaluation of One-day Polyethylene Glycol Powder Solution for Colonoscopy in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Water-Electrolyte Imbalance
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2012-06-22
Enrollment: 178
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children undergoing outpatient colonoscopy

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: electrolyte disturbances
timeFrame: at the time of colonoscopy
measure: PEG-P preparation tolerance
timeFrame: at the time of colonoscopy
Secondary outcomes:
measure: Colonoscopy preparation efficacy
timeFrame: at the time of colonoscopy
measure: Effective communication
timeFrame: at the time of colonoscopy
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Petar Mamula, MD
role: PRINCIPAL_INVESTIGATOR
References: