What this study is
The Investigator propose a randomized trial that will assess whether participant involvement in pre-operative counseling for ERAS improves post-surgical pain scores. The Investigator will also assess participant compliance to ERAS-prescribed medications, and functionality (return to school). Each participant who is enrolled in the study will be assigned to 1) pre-operative counseling with participant's caregiver or 2) caregiver-only counseling.
What's being tested
- Enhanced Recovery After Surgery (ERAS) Counseling to Patients
Intervention · OTHER
- Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver
Intervention · OTHER
Both interventions
In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the patient's caregiver rather than directly to the patient. It is possible that direct patient involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes.
Study details
- Official title
- ERAS in Pediatric and Adolescent Gynecology: How Important is Preoperative Counseling in Patient Outcomes and Does Parent Versus Patient Counseling Impact Success?
- Sponsor
- University of Colorado, Denver
- Conditions
- Enhanced Recovery After Surgery · Gynecologic Disease
- Enrolling
- 60 people
- Starts
- 2022-09-08
- Est. completion
- 2027-06-30
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 9 Years – 17 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 9- 17 years of age
- Patient is undergoing abdominal surgery and being managed under the ERAS protocol
You can't join if
- Developmental delay (IQ < 70) determined by documentation in medical record
- Emergency or non-elective surgical cases
- Patients who attend clinic appointments independently from their caregiver
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openPediatric and Gynecology Clinic at Children's Hospital Colorado
Aurora, Colorado, United States
- Patricia Huguelet, MD · Contact720-777-2238patricia.huguelet@cuanschutz.edu
Recruiting
Study team
Sponsor
University of Colorado, Denver
Study ID 21-3205
Principal investigator
Patricia Huguelet, MD
University of Colorado, Denver
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.