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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-7 days after surgery
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 9 and 17 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Numeric Pain rating scores at post-op days 1 and 7
Secondary outcome measures
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
1,738 Previous Clinical Trials
2,149,466 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants currently being welcomed into this trial?

"Affirmative. Perusal of clinicaltrials.gov reveals that this medical study, which was initially posted on December 30th 2021 and recently updated on October 26th 2021, is currently enrolling patients. There are 60 slots to be filled at one location."

Answered by AI

Who holds the qualifications to apply for this experiment?

"Requirements for the trial necessitate that candidates have experienced enhanced recovery after surgery (ERAS) and are between 9-17 years of age. The study has a maximum capacity of 60 participants."

Answered by AI

Does the scope of this study include individuals aged 70 or above?

"This clinical trial is enrolling individuals aged 9 to 17 years."

Answered by AI

What is the ultimate aim of this research endeavor?

"This clinical trial will evaluate Numeric Pain rating scores and Functionality scores at post-operative day 7, as well as measure the Need for narcotic medications and Rate of narcotic medication prescriptions over a 1 to 7 day period following surgery."

Answered by AI

What is the maximum enrollment for this clinical investigation?

"Affirmative. Clinicaltrials.gov verifies that this experiment is currently recruiting participants, and it was initially posted on December 30th 2021 with a later update logged on October 26th 2021. The trial seeks 60 patients from one center of care."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling
2022. "ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04963751.
~19 spots leftby Jan 2025
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