Thinking of joining a study?

Register your interest

Become a volunteer?

NCT04344899 | RECRUITING | Pelvic Cancer

Pediatric Oncology Recovery Trial After Surgery
Sponsor:

University of Colorado, Denver

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

Pelvic Cancer

Intervention/treatment

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 Type : OBSERVATIONAL
Estimated Enrollment : 288 participants
Official Title : Pediatric Oncology Recovery Trial After Surgery
Actual Study Start Date : 2019-07-23
Estimated Primary Completion Date : 2026-05-09
Estimated Study Completion Date : 2028-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 1 Month to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Pediatric Oncology Recovery Trial After Surgery

Location Details

NCT04344899

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

ACTIVE NOT RECRUITING

United States, Ohio

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

RECRUITING

United States, Tennessee

St Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105