Pediatric Urology Recovery After Surgery Endeavor (PURSUE)
|Urologic Surgical Procedures Urinary Bladder, Neurogenic Urinary Bladder Diseases||Other: Enhanced Recovery after Surgery Other: Historical usual surgical care|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Multicenter Pilot and Exploration Study of Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Urologic Reconstructive Surgery|
- Adherence to ERAS protocol [ Time Frame: 3 years ]Adherence to ERAS protocol items with # of items achieved (out of 20)
- Length of stay [ Time Frame: 3 years ]Median primary inpatient hospital stay associated with surgery episode (# midnights)
- Re-admissions within 30 days [ Time Frame: 30 days ]Median number of re-admissions to any hospital within 30 days of surgery episode per patient
- Re-operations within 90 days [ Time Frame: 90 days ]Median number of unplanned re-operations within 90 days of surgery episode per patient
- Number of visits to the emergency room within 90 day period [ Time Frame: 90 days ]Median number of visits to any emergency room within 90 days of surgery episode per patient
- Number of 30-day complications [ Time Frame: 3 years ]Median number of 30-day compllications by Clavien-Dindo classification per patient
- Number of 90-day complications [ Time Frame: 3 years ]Median number of 90-day complications by Clavien-Dindo classification per patient
- Number of long-term complications within 1 year [ Time Frame: 1 year ]Median number of long-term complications per patient
- Daily IV morphine equivalents [ Time Frame: 3 days after surgery ]Mean daily IV morphine equivalents (mg/kg) usage during first 3 days after surgery
|Actual Study Start Date:||April 1, 2017|
|Estimated Study Completion Date:||April 30, 2020|
|Estimated Primary Completion Date:||April 30, 2019 (Final data collection date for primary outcome measure)|
Enhanced Recovery After Surgery
Prospectively enrolled group to receive standardized care under a set ERAS protocol/pathway.
Other: Enhanced Recovery after Surgery
Enhanced Recovery After Surgery (ERAS) protocol is a multi-disciplinary program that aims to standardize care processes around the pre-, intra-, and post-operative care setting. This group will prospectively receive care under a pre-defined protocol.
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.
Other: Historical usual surgical care
Recent historical controls will have received care under "usual care" that existed prior to implementation of an enhanced recovery protocol.
The purpose of this project is to evaluate Enhanced Recovery After Surgery (ERAS) in the pediatric setting for patients undergoing intraabdominal urologic reconstruction procedures. ERAS practices are being implemented in the department independent of research, this project will allow us to review these practices.
The providers and the patient/family members will complete pre and post surgery questionnaires. These questionnaires are geared to collect demographic information about the patient 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 basically standard of care methodologies.
Data collected from the medical record for each subject will aid in evaluating if adherence to the ERAS protocol is achieved.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03245242
|Contact: Gino Vricella, M.D.||email@example.com|
|Contact: Kyle Rove, M.D.||firstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Kyle Rove, M.D. 314-454-6034 email@example.com|
|Contact: Gino Vricella, M.D. 314-454-6034 firstname.lastname@example.org|
|Principal Investigator:||Kyle Rove, M.D.||Human Research Protection Office (HRPO)|