Image

Pediatric Oncology Recovery Trial After Surgery

Pediatric Oncology Recovery Trial After Surgery

Recruiting
1-18 years
All
Phase N/A

Powered by AI

Overview

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.

Description

Two arms:

Historical patients ERAS patients

Number of patients: 288

Primary outcome

ยท 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)

Eligibility

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 details
    Pelvic Cancer

NCT04344899

University of Colorado, Denver

27 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.