Recruiting

ERAS

Sponsor:

University of Colorado, Denver

Code:

NCT04963751

Conditions

Enhanced Recovery After Surgery

Gynecologic Disease

Eligibility Criteria

Sex: Female

Age: 9 - 17

Healthy Volunteers: Not accepted

Interventions

Enhanced Recovery After Surgery (ERAS) Counseling to Patients

Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver

Study Details

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.

Conditions

Enhanced Recovery After Surgery

Gynecologic Disease

Study ID

NCT04963751

Start date

Sep 8, 2022

Status verified date

Aug, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 9 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: pre-operative counseling with their caregiver

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

placebo comparator: caregiver-only counseling.

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

Interventions

Enhanced Recovery After Surgery (ERAS) Counseling to Patients

In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the patient's caregiver rather than directly to the patient. It is possible that direct patient involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes.

Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver

In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the patient's caregiver rather than directly to the patient. It is possible that direct patient involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes.

Primary outcome measure

  • Numeric Pain rating scores at post-op days 1 and 7 [ Time Frame: 1-7 days after surgery ]

Central Contacts and Locations

Central contacts

Patricia S Huguelet, MD

(720)-777-2238patricia.huguelet@cuanschutz.edu

Jaime Laurin, MS

(720)-777-1375jaime.laurin@cuanschutz.edu

Locations

Pediatric and Gynecology Clinic at Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Patricia Huguelet, MD

720-777-2238patricia.huguelet@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • Gynecology
  • ERAS
  • Pediatrics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-08-11.