Pediatric Oncology Recovery Trial After Surgery

Pelvic Cancer Clinical Trial

— PORTS  

Official title:

Pediatric Oncology Recovery Trial After Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04344899
• Other study ID #: 19-0964.cc
• Secondary ID: NCI-2021-10775
• Status: Recruiting
• Start date: July 23, 2019
• Est. completion date: January 2028

Study information

• Verified date: October 2023
• Source: University of Colorado, Denver
• Contact: Amandla Atilano-Roque
• Phone: 720-777-1497
• Email: AmandlaAtilano-Roque[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: January 2028
• Est. primary completion date: May 9, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Cancer
• Pelvic Neoplasms

Intervention

Other:
• Observational
Enhanced Recovery After Surgery protocol at five tertiary-care pediatric hospitals in pediatric patients undergoing abdominal or retroperitoneal surgical resections for cancer.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado
United States	St Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of 90-day complications by Clavien-Dindo classification		90 Days
Secondary	Number of Adherence issues to ERAS protocol items with # of items achieved (out of 20)		90 Days
Secondary	Length of stay		90 Days
Secondary	Number of Re-admissions within 90 days		90 Days
Secondary	Number of Re-operations within 90 days		90 Days
Secondary	Number of visits to the emergency room within 90 day period		90 Days
Secondary	VAS daily pain score during first 7 days after surgery		90 Days
Secondary	Mean daily IV morphine equivalents (mg/kg) usage during first 7 days after surgery		90 Days
Secondary	Recurrence free survival (months)		90 Days
Secondary	Overall survival (months)		90 Days