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ERAS Preoperative Counseling for Post-Surgical Recovery in Gynecology

N/A
Recruiting
Led By Patricia Huguelet, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
9-17 years of age
Be younger than 18 years old
Must not have
Emergency or non-elective surgical cases
Patients who attend clinic appointments independently from their caregiver
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-7 days after surgery

Summary

This trial will assess whether participant involvement in pre-operative counseling for ERAS (Enhanced Recovery After Surgery) improves post-surgical pain scores. The Investigator will also assess participant compliance to ERAS-prescribed medications, and functionality (return to school).

Who is the study for?
This trial is for young individuals aged 9-17 who are scheduled for abdominal surgery under the ERAS protocol. They must be accompanied by a caregiver to clinic appointments and not have an emergency or non-elective surgical case. Those with developmental delays (IQ < 70) are excluded.
What is being tested?
The study is testing if involving patients in pre-operative counseling alongside their caregivers, as opposed to just the caregivers, improves post-surgical pain management, adherence to prescribed medications, and quicker return to school activities.
What are the potential side effects?
Since this trial focuses on counseling rather than medication or invasive procedures, there are no direct medical side effects expected from participating in the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 9 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I require surgery urgently or unexpectedly.
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I go to my clinic appointments without needing someone to take me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-7 days after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-7 days after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Numeric Pain rating scores at post-op days 1 and 7
Secondary study objectives
Number of participants who have returned to school at 7-days post-op
Rate of medication adherence to ERAS-prescribed medications
Rate of narcotic medication prescriptions

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: pre-operative counseling with their caregiverActive Control1 Intervention
Patients will be asked to attend a standard-of-care pre-operative teaching session with their parent.
Group II: caregiver-only counseling.Placebo Group1 Intervention
Parents-only will attend a standard-of-care pre-operative teaching session.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,800 Previous Clinical Trials
2,821,872 Total Patients Enrolled
Patricia Huguelet, MDPrincipal InvestigatorUniversity of Colorado, Denver

Media Library

pre-operative counseling with their caregiver Clinical Trial Eligibility Overview. Trial Name: NCT04963751 — N/A
Enhanced Recovery After Surgery Research Study Groups: pre-operative counseling with their caregiver, caregiver-only counseling.
Enhanced Recovery After Surgery Clinical Trial 2023: pre-operative counseling with their caregiver Highlights & Side Effects. Trial Name: NCT04963751 — N/A
pre-operative counseling with their caregiver 2023 Treatment Timeline for Medical Study. Trial Name: NCT04963751 — N/A
~4 spots leftby Jan 2025