Pediatric Oncology Recovery Trial After Surgery (PORTS)

University of Colorado Denver (CU Denver)

Status

Enrolling

Conditions

Pelvic Cancer

Treatments

Other: Observational

Study type

Observational

Funder types

Other

Identifiers

NCT04344899

19-0964.cc

NCI-2021-10775 (Other Identifier)

Details and patient eligibility

About

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.

Full 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)

Enrollment

288 estimated patients

Sex

All

Ages

1 month to 18 years old

Volunteers

No Healthy Volunteers

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