Study Results
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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RECRUITING
288 participants
OBSERVATIONAL
2019-07-23
2028-01-31
Brief Summary
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Detailed Description
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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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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Historical
Retrospective Review
Observational
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
1 Month
18 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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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
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
St Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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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.
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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