ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling

NCT04963751 | Recruiting

• 1 other identifier: 21-3205
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Gynecology; ERAS; Pediatrics

Outcome Measures

Primary Outcomes (1)

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

  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.

  1-7 days after surgery

Secondary Outcomes (3)

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

  7 days after surgery

• Rate of medication adherence to ERAS-prescribed medications

  1-7 days after surgery

• Rate of narcotic medication prescriptions

  1-7 days after surgery

Study Arms (2)

pre-operative counseling with their caregiver

ACTIVE COMPARATOR

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

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

caregiver-only counseling.

PLACEBO COMPARATOR

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

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

Interventions

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.

pre-operative counseling with their caregiver

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.

caregiver-only counseling.

Eligibility Criteria

• Age: 9 Years - 17 Years
• Gender Eligibility Details: This study involves only Gynecologic surgeries.
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Pediatric and Gynecology Clinic at Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Related Links

• Enhanced recovery after surgery in pediatric and adolescent gynecology: a pilot study. J Pediatr Adolesc Gynecol 2019; 32: 239
• Implementation of an enhanced recovery protocol in pediatric colorectal surgery. Journal of pediatric surgery, 53(4), 688-692.Kehlet H. (1997)
• The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery
• The effect of pre-admission education on domiciliary recovery following laparoscopic cholecystectomy
• Effects of timing and reinforcement of preoperative education on knowledge and recovery of patients having coronary artery bypass graft surgery. Heart \& lung: the journal of critical care, 20(6), 654-660.
• Preoperative patient preparation in enhanced recovery pathways
• Subanesthetic ketamine infusions for the treatment of children and adolescents with chronic pain: a longitudinal study.
• Multimodal approach to control postoperative pathophysiology and rehabilitation. British journal of anaesthesia, 78(5), 606-617.

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

Enhanced Recovery After Surgery

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative

Study Officials

• Patricia Huguelet, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia S Huguelet, MD

CONTACT

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

Jaime Laurin, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 15, 2021
• Study Start: September 8, 2022
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

US (1)