ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling

Gynecologic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04963751
• Other study ID #: 21-3205
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: Patricia S Huguelet, MD
• Phone: (720)-777-2238
• Email: patricia.huguelet[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 9 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery
• Genital Diseases, Female
• Gynecologic Disease

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Pediatric and Gynecology Clinic at Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants who have returned to school at 7-days post-op	Yes/no question asking whether the participants has returned to school	7 days after surgery
Secondary	Rate of medication adherence to ERAS-prescribed medications	Participants reported adherence to ERAS medications during the post-operative period measured by asking patients which medications they are taking.	1-7 days after surgery
Secondary	Rate of narcotic medication prescriptions	Documentation of narcotic pain medications used during the post-operative period. Assessed via chart review of medical record.	1-7 days after surgery

External Links

•   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.
•   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)
•   Multimodal approach to control postoperative pathophysiology and rehabilitation. British journal of anaesthesia, 78(5), 606-617.
•   Preoperative patient preparation in enhanced recovery pathways
•   Subanesthetic ketamine infusions for the treatment of children and adolescents with chronic pain: a longitudinal study.
•   The effect of pre-admission education on domiciliary recovery following laparoscopic cholecystectomy
•   The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery