ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Gynecologic Disease; Enhanced Recovery After Surgery

Treatments: Other: Enhanced Recovery After Surgery (ERAS) Counseling to Patients; Other: Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver

Study type: Interventional

Funder types: Other

Identifiers

NCT04963751

21-3205

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 9 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

pre-operative counseling with their caregiver

Active Comparator group

Description:

Patients will be asked to attend a standard-of-care pre-operative teaching session with their parent.

Treatment:

Other: Enhanced Recovery After Surgery (ERAS) Counseling to Patients

caregiver-only counseling.

Placebo Comparator group

Description:

Parents-only will attend a standard-of-care pre-operative teaching session.

Treatment:

Other: Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver