Pediatric Oncology Recovery Trial After Surgery

Official Title

Pediatric Oncology Recovery Trial After Surgery

Summary:

Pediatric Oncologic Recovery Trial After Surgery (PORTS) trial is an investigator-initiated, multicentre, 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.

Trial Description

Primary Outcome:

• Number of 90-day complications by Clavien-Dindo classification

Secondary Outcome:

• Number of Adherence issues to ERAS protocol items with # of items achieved (out of 20)
• Length of stay
• Number of Re-admissions within 90 days
• Number of Re-operations within 90 days
• Number of visits to the emergency room within 90 day period
• VAS 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)

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)

View this trial on ClinicalTrials.gov