ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling

Gynecologic Disease Clinical Trial

Official title: ERAS in Pediatric and Adolescent Gynecology: How Important is Preoperative Counseling in Patient Outcomes and Does Parent Versus Patient Counseling Impact Success?

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery
• Genital Diseases, Female
• Gynecologic Disease

• NCT number: NCT04963751
• Study type: Interventional
• Source: University of Colorado, Denver
• Contact: Patricia S Huguelet, MD
• Phone: (720)-777-2238
• Email: patricia.huguelet@cuanschutz.edu
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2022
• Completion date: June 30, 2025