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PORTS: Pediatric Oncology Recovery Trial After Surgery

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT04344899
Collaborator
(none)
288
Enrollment
2
Locations
41.3
Anticipated Duration (Months)
144
Patients Per Site
3.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Observational

Detailed 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)

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
288 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Pediatric Oncology Recovery Trial After Surgery
Actual Study Start Date :
Jul 23, 2019
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Number of Adherence issues to ERAS protocol items with # of items achieved (out of 20) [90 Days]

    2. Length of stay [90 Days]

    3. Number of Re-admissions within 90 days [90 Days]

    4. Number of Re-operations within 90 days [90 Days]

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

    6. VAS daily pain score during first 7 days after surgery [90 Days]

    7. Mean daily IV morphine equivalents (mg/kg) usage during first 7 days after surgery [90 Days]

    8. Recurrence free survival (months) [90 Days]

    9. Overall survival (months) [90 Days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital Colorado Aurora Colorado United States 80045
    2 St Jude Children's Research Hospital Memphis Tennessee United States 38105

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT04344899
    Other Study ID Numbers:
    • 19-0964.cc
    First Posted:
    Apr 14, 2020
    Last Update Posted:
    Jun 13, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pelvic Neoplasms

    Study Results

    No Results Posted as of Jun 13, 2022