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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Petar Mamula, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01626040
First received: June 20, 2012
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Water-Electrolyte Imbalance
Drug: polyethylene glycol powder

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of One-day Polyethylene Glycol Powder Solution for Colonoscopy in Children

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • electrolyte disturbances [ Time Frame: at the time of colonoscopy ] [ Designated as safety issue: Yes ]
    the proportion of patients with clinically significant serum electrolyte abnormalities at the time of colonoscopy

  • PEG-P preparation tolerance [ Time Frame: at the time of colonoscopy ] [ Designated as safety issue: No ]
    Responses to a questionnaire regarding the tolerance of the PEG-P prep will be recorded


Secondary Outcome Measures:
  • Colonoscopy preparation efficacy [ Time Frame: at the time of colonoscopy ] [ Designated as safety issue: No ]
    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

  • Effective communication [ Time Frame: at the time of colonoscopy ] [ Designated as safety issue: No ]
    Effectiveness of communication strategy about the prep and availability of staff to address questions reported by parents will be summarized


Biospecimen Description:

No biospecimens are to be retained


Enrollment: 178
Study Start Date: June 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

children undergoing outpatient colonoscopy

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626040

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Petar Mamula, MD Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Petar Mamula, Medical Doctor, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01626040     History of Changes
Other Study ID Numbers: 12-008643
Study First Received: June 20, 2012
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014