Pelvic Cancer
Conditions
Brief summary
Pediatric Oncologic Recovery Trial After Surgery (PORTS) trial is an investigator-initiated, multicenter, multidisciplinary prospective case-control study of the implementation of an Enhanced Recovery After Surgery (ERAS) protocol at five tertiary-care pediatric hospitals in pediatric patients undergoing abdominal or retroperitoneal surgical resections for cancer. A pilot phase will determine characteristics of a successful protocol implementation and an exploratory phase plans to examine adherence, objective patient outcomes, and patient-reported outcomes. After completing primary enrollment, this collaborative will continue to enroll patients in the shared data registry and continue to refine the underlying ERAS protocol developed for this project.
Detailed description
Two arms: Historical patients ERAS patients Number of patients: 288 Primary outcome · Number of 90-day complications by Clavien-Dindo classification Secondary outcome(s): * Adherence to ERAS protocol items with # of items achieved (out of 20) * Length of stay * Re-admissions within 90 days * Re-operations within 90 days * Number of visits to the emergency room within 90 day period * Minimum, mean, maximum daily pain score during first 7 days after surgery * Mean daily IV morphine equivalents (mg/kg) usage during first 7 days after surgery * recurrence free survival (months) * overall survival (months)
Interventions
OTHERObservational
Enhanced Recovery After Surgery protocol at five tertiary-care pediatric hospitals in pediatric patients undergoing abdominal or retroperitoneal surgical resections for cancer.
Sponsors
University of Colorado, Denver
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing operations at a pediatric hospital setting aged 1 month or older * Parents of patients undergoing operations at pediatric hospital settings aged 1 month or older * Undergoing urologic reconstruction, ureteral operations, pyeloplasty, intraabdominal on-cologic resections, urachal remnant excision, bariatric operations, pectus surgery, ap-pendicitis, orthopedic or neurosurgical operations and inflammatory bowel disease proce-dures * Providers of patients undergoing surgery in pediatric settings
Exclusion criteria
* Less than 1 month in age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of 90-day complications by Clavien-Dindo classification | 90 Days |
Secondary
| Measure | Time frame |
|---|---|
| Length of stay | 90 Days |
| Number of Re-admissions within 90 days | 90 Days |
| Number of Re-operations within 90 days | 90 Days |
| Number of visits to the emergency room within 90 day period | 90 Days |
| Number of Adherence issues to ERAS protocol items with # of items achieved (out of 20) | 90 Days |
| Mean daily IV morphine equivalents (mg/kg) usage during first 7 days after surgery | 90 Days |
| Recurrence free survival (months) | 90 Days |
| Overall survival (months) | 90 Days |
| VAS daily pain score during first 7 days after surgery | 90 Days |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKyle Rove, MD
Childrens Hospital Colorado
Outcome results
None listed