ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Enhanced Recovery After Surgery, Gynecologic Disease

Intervention / Treatment
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* Other: Enhanced Recovery After Surgery (ERAS) Counseling to Patients
* Other: Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pre-operative counseling with their caregiver<br>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<br>* 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.<br>|
| Placebo Comparator: caregiver-only counseling.<br>Parents-only will attend a standard-of-care pre-operative teaching session. | Other: Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gynecology, ERAS, Pediatrics