Pediatric Oncology Recovery Trial After Surgery

Last updated: February 6, 2025
Sponsor: University of Colorado, Denver
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pelvic Cancer

Treatment

Observational

Clinical Study ID

NCT04344899
19-0964.cc
NCI-2021-10775
  • Ages 1-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 1month or older

  • Undergoing urologic reconstruction, ureteral operations, pyeloplasty, intraabdominalon-cologic resections, urachal remnant excision, bariatric operations, pectussurgery, ap-pendicitis, orthopedic or neurosurgical operations and inflammatorybowel disease proce-dures

  • Providers of patients undergoing surgery in pediatric settings

Exclusion

Exclusion Criteria:

  • Less than 1 month in age

Study Design

Total Participants: 288
Treatment Group(s): 1
Primary Treatment: Observational
Phase:
Study Start date:
July 23, 2019
Estimated Completion Date:
January 31, 2028

Study 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)

Connect with a study center

  • Alberta Children's Hospital

    Calgary, Alberta
    Canada

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • St Jude Children's Research Hospital

    Memphis, Tennessee 38105
    United States

    Active - Recruiting

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