Enhanced Recovery After Surgery, Gynecologic Disease
Conditions
Keywords
Gynecology, ERAS, Pediatrics
Brief 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). 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
OTHEREnhanced 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.
OTHEREnhanced 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.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain rating scores at post-op days 1 and 7 | 1-7 days after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who have returned to school at 7-days post-op | 7 days after surgery | Yes/no question asking whether the participants has returned to school |
| Rate of medication adherence to ERAS-prescribed medications | 1-7 days after surgery | Participants reported adherence to ERAS medications during the post-operative period measured by asking patients which medications they are taking. |
| Rate of narcotic medication prescriptions | 1-7 days after surgery | Documentation of narcotic pain medications used during the post-operative period. Assessed via chart review of medical record. |
Countries
United States
Contacts
CONTACTPatricia S Huguelet, MD
CONTACTJaime Laurin, MS
PRINCIPAL_INVESTIGATORPatricia Huguelet, MD
University of Colorado, Denver
Outcome results
None listed