Pediatric Oncology Recovery Trial After Surgery

NCT ID: NCT04344899

Last Updated: 2025-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

288 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-23

Study Completion Date

2028-01-31

Brief Summary

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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

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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)

Conditions

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Pelvic Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Historical

Retrospective Review

Observational

Intervention Type OTHER

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

ERAS Patients

Prospective Review

Observational

Intervention Type OTHER

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

Interventions

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Observational

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

Intervention Type OTHER

Other Intervention Names

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ERAS Protocol

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyle Rove, MD

Role: PRINCIPAL_INVESTIGATOR

Childrens Hospital Colorado

Locations

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Children's Hospital Colorado

Aurora, Colorado, United States

Site Status RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

St Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer Pyrzanowski

Role: CONTACT

1.303.724.0769

Facility Contacts

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Kyle Rove, MD

Role: primary

720-777-5084

Liza Emanus

Role: primary

References

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Mansfield SA, Kotagal M, Hartman S, Murphy AJ, Davidoff AM, Anghelescu DL, Mecoli M, Cost N, Hogan B, Rove KO. Development of an enhanced recovery after surgery program for pediatric solid tumors. Front Surg. 2024 May 22;11:1393857. doi: 10.3389/fsurg.2024.1393857. eCollection 2024.

Reference Type DERIVED
PMID: 38840973 (View on PubMed)

Other Identifiers

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NCI-2021-10775

Identifier Type: OTHER

Identifier Source: secondary_id

19-0964.cc

Identifier Type: -

Identifier Source: org_study_id

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