NCT04344899

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 23, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2025

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

5.6 years

First QC Date

April 9, 2020

Last Update Submit

March 9, 2026

Conditions

Pelvic Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of 90-day complications by Clavien-Dindo classification

    90 Days

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Historical

Retrospective Review

Other: Observational

ERAS Patients

Prospective Review

Other: Observational

Interventions

ObservationalOTHER

Enhanced Recovery After Surgery protocol at five tertiary-care pediatric hospitals in pediatric patients undergoing abdominal or retroperitoneal surgical resections for cancer.

Also known as: ERAS Protocol
ERAS PatientsHistorical

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients undergoing urological surgery

You may qualify if:

  • 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

You may not qualify if:

  • Less than 1 month in age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

St Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

  • Mansfield SA, Kotagal M, Hartman S, Murphy AJ, Davidoff AM, Anghelescu DL, Mecoli M, Cost N, Hogan B, Rove KO. Development of an enhanced recovery after surgery program for pediatric solid tumors. Front Surg. 2024 May 22;11:1393857. doi: 10.3389/fsurg.2024.1393857. eCollection 2024.

    PMID: 38840973DERIVED

MeSH Terms

Conditions

Pelvic Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Kyle Rove, MD

    Childrens Hospital Colorado

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 14, 2020

Study Start

July 23, 2019

Primary Completion

March 11, 2025

Study Completion

March 11, 2025

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)