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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.
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)
Age
0 - 18 years
Sex
ALL
Healthy Volunteers
No
Children's Hospital Colorado
Aurora, Colorado, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
St Jude Children's Research Hospital
Memphis, Tennessee, United States
Start Date
July 23, 2019
Primary Completion Date
March 11, 2025
Completion Date
March 11, 2025
Last Updated
March 11, 2026
74
ACTUAL participants
Observational
OTHER
Lead Sponsor
University of Colorado, Denver
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06397573