Pediatric Oncology Recovery Trial After Surgery (PORTS)

March 9, 2026 updated by: University of Colorado, Denver
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients undergoing urological surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Historical
Retrospective Review
Other: Observational
Enhanced Recovery After Surgery protocol at five tertiary-care pediatric hospitals in pediatric patients undergoing abdominal or retroperitoneal surgical resections for cancer.
Other Names:
  • ERAS Protocol
ERAS Patients
Prospective Review
Other: Observational
Enhanced Recovery After Surgery protocol at five tertiary-care pediatric hospitals in pediatric patients undergoing abdominal or retroperitoneal surgical resections for cancer.
Other Names:
  • ERAS Protocol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Adherence issues to ERAS protocol items with # of items achieved (out of 20)
Time Frame: 90 Days
90 Days
Length of stay
Time Frame: 90 Days
90 Days
Number of Re-admissions within 90 days
Time Frame: 90 Days
90 Days
Number of Re-operations within 90 days
Time Frame: 90 Days
90 Days
Number of visits to the emergency room within 90 day period
Time Frame: 90 Days
90 Days
VAS daily pain score during first 7 days after surgery
Time Frame: 90 Days
90 Days
Mean daily IV morphine equivalents (mg/kg) usage during first 7 days after surgery
Time Frame: 90 Days
90 Days
Recurrence free survival (months)
Time Frame: 90 Days
90 Days
Overall survival (months)
Time Frame: 90 Days
90 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Kyle Rove, MD, Childrens Hospital Colorado

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2019

Primary Completion (Actual)

March 11, 2025

Study Completion (Actual)

March 11, 2025

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

April 9, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-0964.cc
  • NCI-2021-10775 (Other Identifier: CTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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