Evaluation of One-day Polyethylene Glycol Powder Solution for Colonoscopy in Children
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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 |
- 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
- 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
| Estimated Enrollment: | 150 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | April 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 |
children undergoing outpatient colonoscopy
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| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Petar Mamula, MD 215-590-9146 | |
| Principal Investigator: Petar Mamula, MD | |
| Sub-Investigator: Benjamin Sahn, MD | |
| 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 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Water-Electrolyte Imbalance Metabolic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013