Improving preoperative counseling for young patients in gynecology
ERAS in Pediatric and Adolescent Gynecology: How Important is Preoperative Counseling in Patient Outcomes and Does Parent Versus Patient Counseling Impact Success?
This study is testing if giving direct pre-operative counseling to young patients and their caregivers can help improve pain management and recovery after abdominal surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 9 Years to 17 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT04963751 on ClinicalTrials.gov |
What this trial studies
This trial investigates the impact of direct pre-operative counseling for pediatric and adolescent patients undergoing abdominal surgery under the Enhanced Recovery After Surgery (ERAS) protocol. Participants will be randomly assigned to receive counseling either with their caregiver or solely for the caregiver. The study aims to evaluate whether this direct involvement can enhance post-surgical pain management, medication compliance, and overall functionality, such as returning to school. The research seeks to identify key elements of ERAS that contribute to better outcomes in this population.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 9 to 17 who are scheduled for abdominal surgery under the ERAS protocol.
Not a fit: Patients with developmental delays or those undergoing emergency surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and quicker recovery for young patients after surgery.
How similar studies have performed: While ERAS protocols have been established, this specific approach of involving young patients in pre-operative counseling has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 9- 17 years of age * Patient is undergoing abdominal surgery and being managed under the ERAS protocol Exclusion Criteria: * 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
Where this trial is running
Aurora, Colorado
- Pediatric and Gynecology Clinic at Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Patricia Huguelet, MD — University of Colorado, Denver
- Study coordinator: Patricia S Huguelet, MD
- Email: patricia.huguelet@cuanschutz.edu
- Phone: (720)-777-2238
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.