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NCT Number: NCT04963751

ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling

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.

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Key information

Conditions

Enhanced Recovery After Surgery Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynecologic Disease Urogenital Diseases

Age range

9 year–17 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric and Gynecology Clinic at Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Patricia Huguelet, MD

CONTACT

[email protected]

720-777-2238

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced Recovery After Surgery (ERAS) Counseling to Patients

Other

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

Other

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 outcomes

  1. Numeric Pain rating scores at post-op days 1 and 7

    Time frame: 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 outcomes

  1. Number of participants who have returned to school at 7-days post-op

    Time frame: 7 days after surgery

    Yes/no question asking whether the participants has returned to school

  2. Rate of medication adherence to ERAS-prescribed medications

    Time frame: 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.

  3. Rate of narcotic medication prescriptions

    Time frame: 1-7 days after surgery

    Documentation of narcotic pain medications used during the post-operative period. Assessed via chart review of medical record.

Study contacts

Contact information is provided by the study sponsor or research team.

Jaime Laurin, MS

CONTACT

[email protected]

(720)-777-1375

Patricia S Huguelet, MD

CONTACT

[email protected]

(720)-777-2238

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2021
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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