Pediatric Oncology Recovery Trial After Surgery

Recruiting

• Conditions: Pelvic Cancer
• Interventions: Other: Observational

• Registration Number: NCT04344899
• Lead 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.

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 Timeline

• Study Start: 2019-07-23
• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-14
• Status Verified: 2024-10
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2026-05-09
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 288

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

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Exclusion Criteria

• Less than 1 month in age

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ERAS Patients	Observational	Prospective Review
Historical	Observational	Retrospective Review

Primary Outcome Measures

Name	Time	Method
Number of 90-day complications by Clavien-Dindo classification	90 Days

Secondary Outcome Measures

Name	Time	Method
Number of Adherence issues to ERAS protocol items with # of items achieved (out of 20)	90 Days
Number of Re-admissions within 90 days	90 Days
Length of stay	90 Days
Mean daily IV morphine equivalents (mg/kg) usage during first 7 days after surgery	90 Days
Number of Re-operations within 90 days	90 Days
Recurrence free survival (months)	90 Days
VAS daily pain score during first 7 days after surgery	90 Days
Number of visits to the emergency room within 90 day period	90 Days
Overall survival (months)	90 Days

Trial Locations

Locations (3)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

St Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States