NCT04344899

Pediatric Oncology Recovery Trial After Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 74 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Pelvic Cancer

Interventions

Type	Name	Description
OTHER	Observational	Enhanced Recovery After Surgery protocol at five tertiary-care pediatric hospitals in pediatric patients undergoing abdominal or retroperitoneal surgical resections for cancer.

Timeline

• Start date: 2019-07-23
• Primary completion: 2025-03-11
• Completion: 2025-03-11
• First posted: 2020-04-14
• Last updated: 2026-03-11

Locations

3 sites across 1 country: United States