Clinical trial NCT04344899: Pediatric Oncology Recovery Trial After Surgery
Official title: Pediatric Oncology Recovery Trial After Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 288
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients undergoing urological surgery

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)

Eligibility 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

Primary outcomes:
measure: Number of 90-day complications by Clavien-Dindo classification
timeFrame: 90 Days
Secondary outcomes:
measure: Number of Adherence issues to ERAS protocol items with # of items achieved (out of 20)
timeFrame: 90 Days
measure: Length of stay
timeFrame: 90 Days
measure: Number of Re-admissions within 90 days
timeFrame: 90 Days
measure: Number of Re-operations within 90 days
timeFrame: 90 Days
measure: Number of visits to the emergency room within 90 day period
timeFrame: 90 Days
measure: VAS daily pain score during first 7 days after surgery
timeFrame: 90 Days
measure: Mean daily IV morphine equivalents (mg/kg) usage during first 7 days after surgery
timeFrame: 90 Days
measure: Recurrence free survival (months)
timeFrame: 90 Days
measure: Overall survival (months)
timeFrame: 90 Days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Memphis
country: United States
facility: St Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: Childrens Hospital Colorado
name: Kyle Rove, MD
role: PRINCIPAL_INVESTIGATOR
References: