Clinical trial NCT04963751: ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling
Official title: ERAS in Pediatric and Adolescent Gynecology: How Important is Preoperative Counseling in Patient Outcomes and Does Parent Versus Patient Counseling Impact Success?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Enhanced Recovery After Surgery
Gynecologic Disease
Keywords: Gynecology
ERAS
Pediatrics
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized trial is proposed that will assess whether patient involvement in pre-operative counseling for ERAS improves post-surgical pain scores. Subject compliance will be assessed to ERAS-prescribed medications, and functionality (return to school). Each patient who is enrolled in the study will be assigned to 1) pre-operative counseling with their caregiver or 2) caregiver-only counseling.
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Numeric Pain rating scores at post-op days 1 and 7
timeFrame: 1-7 days after surgery
Secondary outcomes:
measure: Number of participants who have returned to school at 7-days post-op
timeFrame: 7 days after surgery
measure: Rate of medication adherence to ERAS-prescribed medications
timeFrame: 1-7 days after surgery
measure: Rate of narcotic medication prescriptions
timeFrame: 1-7 days after surgery
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Pediatric and Gynecology Clinic at Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Patricia Huguelet, MD
role: PRINCIPAL_INVESTIGATOR
References: