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Completed

NCT Number: NCT01626040

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

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.

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Key information

Conditions

Water-Electrolyte Imbalance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

polyethylene glycol powder

Drug

A single group of children taking a polyethylene glycol powder preparation, dosage determined by patient weight, taken in one dose the day before colonoscopy

Primary outcomes

  1. electrolyte disturbances

    Time frame: at the time of colonoscopy

    the proportion of patients with clinically significant serum electrolyte abnormalities at the time of colonoscopy

  2. PEG-P preparation tolerance

    Time frame: at the time of colonoscopy

    Responses to a questionnaire regarding the tolerance of the PEG-P prep will be recorded

Secondary outcomes

  1. Colonoscopy preparation efficacy

    Time frame: at the time of colonoscopy

    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

  2. Effective communication

    Time frame: at the time of colonoscopy

    Effectiveness of communication strategy about the prep and availability of staff to address questions reported by parents will be summarized

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 22, 2012
Registry last updated
Jan 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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