Enhanced Recovery After SurgeryNCT04963751
ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling
A study testing Enhanced Recovery After Surgery (ERAS) Counseling to Patients and Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver in people with Enhanced Recovery After Surgery and Gynecologic Disease, run by University of Colorado, Denver at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 9 to 17 years, women only
- Conditions the study is for
- Enhanced Recovery After Surgery, Gynecologic Disease
- What is being tested?
- Enhanced Recovery After Surgery (ERAS) Counseling to Patients and Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2022to 30 Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 9- 17 years of age
- Patient is undergoing abdominal surgery and being managed under the ERAS protocol
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pediatric and Gynecology Clinic at Children's Hospital Colorado
Aurora, Colorado, 80045
Patricia Huguelet, MD, 720-777-2238, patricia.huguelet@cuanschutz.edu
About this study
Official title: ERAS in Pediatric and Adolescent Gynecology: How Important is Preoperative Counseling in Patient Outcomes and Does Parent Versus Patient Counseling Impact Success?
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.
Read the detailed 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.
- Being tested
- Enhanced Recovery After Surgery (ERAS) Counseling to Patients, Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver
- Keywords
- Gynecology, ERAS, Pediatrics
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After Surgery (ERAS) Counseling to PatientsOther
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 CaregiverOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-7 days after surgery
Secondary outcomes (3)
Number of participants who have returned to school at 7-days post-op
Yes/no question asking whether the participants has returned to school
Measured: 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.
Measured: 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.
Measured: 1-7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start8 Sep 2022
- Primary completion31 Jan 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Recovery After SurgeryStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Huguelet, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963751
- Sponsor's protocol ID
- 21-3205
- Status last verified
- Aug 2026
- First submitted
- 12 Jul 2021
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No