Pediatric Oncology Recovery Trial After Surgery (PORTS)

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: Recruiting
• Conditions: Pelvic Cancer
• Intervention / Treatment: Other: Observational

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 (Estimated): 288

Contacts and Locations

• Study Contact: Name: Amandla Atilano-Roque; Phone Number: 720-777-1497; Email: AmandlaAtilano-Roque@childrenscolorado.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
      • Contact: Kyle Rove, MD; Phone Number: 720-777-5084; Email: kyle.rove@childrenscolorado.org
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Recruiting
      • St Jude Children's Research Hospital
      • Contact: Liza Emanus; Email: liza.emanus@stjude.org
      • Principal Investigator: Sara Mansfield, MD

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	90 Days

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Kyle Rove, MD, Childrens Hospital Colorado

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2019
• Primary Completion (Estimated): May 9, 2026
• Study Completion (Estimated): January 1, 2028

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): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pelvic Neoplasms
• 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