ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling

Not Applicable

Recruiting

• Conditions: Enhanced Recovery After Surgery; Gynecologic Disease
• Interventions: Other: Enhanced Recovery After Surgery (ERAS) Counseling to Patients; Other: Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver

• Registration Number: NCT04963751
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Study Timeline

• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-12
• Study First Posted: 2021-07-15
• Study Start: 2022-09-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-02
• Primary Completion: 2025-01-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 9- 17 years of age
• Patient is undergoing abdominal surgery and being managed under the ERAS protocol

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pre-operative counseling with their caregiver	Enhanced Recovery After Surgery (ERAS) Counseling to Patients	Patients will be asked to attend a standard-of-care pre-operative teaching session with their parent.
caregiver-only counseling.	Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver	Parents-only will attend a standard-of-care pre-operative teaching session.

Primary Outcome Measures

Name	Time	Method
Numeric Pain rating scores at post-op days 1 and 7	1-7 days after surgery	Minimum value = 0, maximum value = 10. 0 = no pain at all, 10 = worst pain imaginable. A higher score on the rating scale indicates a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Rate of medication adherence to ERAS-prescribed medications	1-7 days after surgery	Participants reported adherence to ERAS medications during the post-operative period measured by asking patients which medications they are taking.
Number of participants who have returned to school at 7-days post-op	7 days after surgery	Yes/no question asking whether the participants has returned to school
Rate of narcotic medication prescriptions	1-7 days after surgery	Documentation of narcotic pain medications used during the post-operative period. Assessed via chart review of medical record.

Trial Locations

Locations (1)

Pediatric and Gynecology Clinic at Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States