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Completed

NCT Number: NCT04344899

Pediatric Oncology Recovery Trial After Surgery

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.

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Key information

Conditions

Pelvic Cancer Neoplasms Neoplasms by Site Pelvic Neoplasms

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado, Aurora, Colorado, United States

Loading trial locations.

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

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

Primary outcomes

  1. Number of 90-day complications by Clavien-Dindo classification

    Time frame: 90 Days

Secondary outcomes

  1. Number of Adherence issues to ERAS protocol items with # of items achieved (out of 20)

    Time frame: 90 Days

  2. Length of stay

    Time frame: 90 Days

  3. Number of Re-admissions within 90 days

    Time frame: 90 Days

  4. Number of Re-operations within 90 days

    Time frame: 90 Days

  5. Number of visits to the emergency room within 90 day period

    Time frame: 90 Days

  6. VAS daily pain score during first 7 days after surgery

    Time frame: 90 Days

  7. Mean daily IV morphine equivalents (mg/kg) usage during first 7 days after surgery

    Time frame: 90 Days

  8. Recurrence free survival (months)

    Time frame: 90 Days

  9. Overall survival (months)

    Time frame: 90 Days

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Acronym: PORTS

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2020
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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