Pediatric Oncology Recovery Trial After Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Pediatric Oncology Recovery Trial After Surgery

Conditions
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Pelvic Cancer

Intervention / Treatment
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* Other: Observational


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Historical<br>Retrospective Review | Other: Observational<br>* Enhanced Recovery After Surgery protocol at five tertiary-care pediatric hospitals in pediatric patients undergoing abdominal or retroperitoneal surgical resections for cancer.<br>* Other names: ERAS Protocol;|
| ERAS Patients<br>Prospective Review | Other: Observational<br>* Enhanced Recovery After Surgery protocol at five tertiary-care pediatric hospitals in pediatric patients undergoing abdominal or retroperitoneal surgical resections for cancer.<br>* Other names: ERAS Protocol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of 90-day complications by Clavien-Dindo classification |  | 90 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adherence issues to ERAS protocol items with # of items achieved (out of 20) |  | 90 Days | 
| 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 | 
| VAS daily pain score during first 7 days after surgery |  | 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 |