We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pediatric Oncology Recovery Trial After Surgery (PORTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04344899
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : October 17, 2022
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Pelvic Cancer 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 288 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 90 Days
Official Title: Pediatric Oncology Recovery Trial After Surgery
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : May 9, 2026
Estimated Study Completion Date : January 2028
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: ERAS Protocol


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of 90-day complications by Clavien-Dindo classification [ Time Frame: 90 Days ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients undergoing urological surgery
Criteria

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344899


Contacts
Layout table for location contacts
Contact: Amandla Atilano-Roque 720-777-1497 AmandlaAtilano-Roque@childrenscolorado.org

Locations
Layout table for location information
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Kyle Rove, MD    720-777-5084    kyle.rove@childrenscolorado.org   
United States, Tennessee
St Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Liza Emanus       liza.emanus@stjude.org   
Principal Investigator: Sara Mansfield, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Layout table for investigator information
Principal Investigator: Kyle Rove, MD Childrens Hospital Colorado
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04344899    
Other Study ID Numbers: 19-0964.cc
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: October 17, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pelvic Neoplasms
Neoplasms by Site
Neoplasms