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NCT04963751NARecruiting

ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling

University of Colorado, Denver

Start Date

9/8/2022

Completion Date

6/30/2027

Summary

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.

Detailed Description

Enhanced Recovery After Surgery (ERAS) protocols have been shown to be safe and effective in pediatric and adolescent gynecology (PAG) participants. However, the individual elements of ERAS that are associated with positive outcomes have not been identified. Pre-operative counseling and education is a standard component of ERAS. In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the participant's caregiver rather than directly to the participant. It is possible that direct participant involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes. To investigator's knowledge, no studies have examined the impact of direct participant involvement in pre-operative counseling on ERAS outcomes in the PAG population. 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.

Eligibility Criteria

Age Range: 9 years to 17 years

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

Interventions

OTHER

Enhanced Recovery After Surgery (ERAS) Counseling to Patients

OTHER

Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver

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Conditions

Enhanced Recovery After SurgeryGynecologic Disease

Locations

Pediatric and Gynecology Clinic at Children's Hospital Colorado

Aurora, Colorado 80045

United States