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Pediatric Urology Recovery After Surgery Endeavor (PURSUE)

Active, not recruiting
Conditions
Urinary Bladder Diseases
Urologic Surgical Procedures
Urinary Bladder, Neurogenic
Interventions
Other: Enhanced Recovery after Surgery
Other: Historical usual surgical care
Registration Number
NCT03245242
Lead Sponsor
Washington University School of Medicine
Brief Summary

The purpose of this research study is to evaluate an Enhanced Recovery After Surgery (ERAS) protocol in children and young adults undergoing urologic reconstructive surgery. The investigators plan to collect data on speed of recovery (how quickly pain improves, length of time in the hospital, and the need for additional pain control) on patients who receive care under the ERAS protocol and compare it to historical controls.

Detailed Description

The purpose of this project is to evaluate Enhanced Recovery After Surgery (ERAS) in the pediatric setting for participants undergoing intraabdominal urologic reconstruction procedures. ERAS practices are being implemented in the department independent of research and this project will allow the investigators to review these practices.

Providers, participants, and family members will complete pre- and post- surgery questionnaires. These questionnaires are geared to collect demographic information about the participant and how the surgery affects their life situation. The providers will answer questions regarding their experience with ERAS.

Evidence-based ERAS principles and procedures are compulsory components of this project. These will be documented in the medical record and are considered standard of care practice as part of perioperative patient care.

Data collected from the medical record for each participant will aid in evaluating if adherence to the ERAS protocol is achieved.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
85
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Enhanced Recovery After SurgeryEnhanced Recovery after SurgeryProspectively enrolled group to receive standardized care under a set ERAS protocol/pathway.
Historical usual surgical careHistorical usual surgical careRecent historical patients (5 years prior to start of ERAS) that will be propensity-matched to ERAS patients to be used as controls for comparison of outcomes.
Primary Outcome Measures
NameTimeMethod
Adherence to ERAS protocol3 years

Adherence to ERAS protocol items with # of items achieved (out of 20)

Secondary Outcome Measures
NameTimeMethod
Number of 90-day complications3 years

Median number of 90-day complications by Clavien-Dindo classification per patient

Number of visits to the emergency room within 90 day period90 days

Median number of visits to any emergency room within 90 days of surgery episode per patient

Number of long-term complications within 1 year1 year

Median number of long-term complications per patient

Length of stay3 years

Median primary inpatient hospital stay associated with surgery episode (# midnight)

Re-operations within 90 days90 days

Median number of unplanned re-operations within 90 days of surgery episode per patient

Number of 30-day complications3 years

Median number of 30-day complications by Clavien-Dindo classification per patient

Re-admissions within 30 days30 days

Median number of re-admissions to any hospital within 30 days of surgery episode per patient

Daily IV morphine equivalents3 days after surgery

Mean daily IV morphine equivalents (mg/kg) usage during first 3 days after surgery

Trial Locations

Locations (7)

Children's Hospital Colorado

🇺🇸

Aurora, Colorado, United States

Ann & Robert Lurie Children's Hospital of Chicago

🇺🇸

Chicago, Illinois, United States

Cincinnati Children's Hospital Medical Center

🇺🇸

Cincinnati, Ohio, United States

Children's Hospital of Pittsburgh of UPMC

🇺🇸

Pittsburgh, Pennsylvania, United States

Oklahoma University Health Science Center

🇺🇸

Oklahoma City, Oklahoma, United States

Washington University School of Medicine

🇺🇸

Saint Louis, Missouri, United States

Children's Hospital of Richmond at Virginia Commonwealth University

🇺🇸

Richmond, Virginia, United States

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