ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enhanced Recovery After Surgery (ERAS) Counseling to Patients, Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver.
- Who it may be relevant to
- Registry conditions: Enhanced Recovery After Surgery, Gynecologic Disease. Basic parameters: 9 years — 17 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ERAS in Pediatric and Adolescent Gynecology: How Important is Preoperative Counseling in Patient Outcomes and Does Parent Versus Patient Counseling Impact Success?
Overview
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
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.
Interventions
- 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. - Other 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.
Primary outcome measures
- Numeric Pain rating scores at post-op days 1 and 7 [Time frame: 1-7 days after surgery]
Secondary outcome measures (3)
- Number of participants who have returned to school at 7-days post-op [Time frame: 7 days after surgery]
- Rate of medication adherence to ERAS-prescribed medications [Time frame: 1-7 days after surgery]
- Rate of narcotic medication prescriptions [Time frame: 1-7 days after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Pediatric and Gynecology Clinic at Children's Hospital Colorado — Aurora
Identifiers
NCT: NCT04963751 · 21-3205