Pediatric Urology Recovery After Surgery Endeavor (PURSUE)
- Conditions
- Urinary Bladder DiseasesUrologic Surgical ProceduresUrinary Bladder, Neurogenic
- Interventions
- Other: Enhanced Recovery after SurgeryOther: 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
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Enhanced Recovery After Surgery Enhanced Recovery after Surgery Prospectively enrolled group to receive standardized care under a set ERAS protocol/pathway. Historical usual surgical care Historical usual surgical care Recent 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
Name Time Method Adherence to ERAS protocol 3 years Adherence to ERAS protocol items with # of items achieved (out of 20)
- Secondary Outcome Measures
Name Time Method Number of 90-day complications 3 years Median number of 90-day complications by Clavien-Dindo classification per patient
Number of visits to the emergency room within 90 day period 90 days Median number of visits to any emergency room within 90 days of surgery episode per patient
Number of long-term complications within 1 year 1 year Median number of long-term complications per patient
Length of stay 3 years Median primary inpatient hospital stay associated with surgery episode (# midnight)
Re-operations within 90 days 90 days Median number of unplanned re-operations within 90 days of surgery episode per patient
Number of 30-day complications 3 years Median number of 30-day complications by Clavien-Dindo classification per patient
Re-admissions within 30 days 30 days Median number of re-admissions to any hospital within 30 days of surgery episode per patient
Daily IV morphine equivalents 3 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