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

Water-Electrolyte Imbalance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626040
• Other study ID #: 12-008643
• Status: Completed
• Phase: N/A
• First received: June 20, 2012
• Last updated: January 16, 2014
• Start date: June 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Water-Electrolyte Imbalance

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	electrolyte disturbances	the proportion of patients with clinically significant serum electrolyte abnormalities at the time of colonoscopy	at the time of colonoscopy	Yes
Primary	PEG-P preparation tolerance	Responses to a questionnaire regarding the tolerance of the PEG-P prep will be recorded	at the time of colonoscopy	No
Secondary	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	No
Secondary	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	No