Pediatric Urology Recovery After Surgery Endeavor (PURSUE)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicenter Pilot and Exploration Study of Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Urologic Reconstructive Surgery

Conditions
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Urologic Surgical Procedures, Urinary Bladder, Neurogenic, Urinary Bladder Diseases

Intervention / Treatment
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* Other: Enhanced Recovery after Surgery
* Other: Historical usual surgical care


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age greater than or equal to 4 or <26 years at time of surgery Undergoing urologic reconstructive surgery that includes primary bowel anastomosis (i.e., creation of continent ileovesicostomy [Monti], sigmoid Monti channel, enterocystoplasty) Undergoing urologic reconstructive surgery that includes possible bowel anastomosis (planned creation of continent appendicovesicostomy [Mitrofanoff] with inability to use appendix at time of surgery and creation of alternative channel requiring primary bowel anastomosis) Exclusion criteria: • Clinically constipated (defined as Bristol 1 or 2 stools more than once per week, bowel movement interval > every other day [e.g. only has bowel movement every 3 days, or palpable stool in > 50% of colon on physical preoperative exam)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Enhanced Recovery After Surgery<br>Prospectively enrolled group to receive standardized care under a set ERAS protocol/pathway. | Other: Enhanced Recovery after Surgery<br>* 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.<br>|
| Historical usual surgical care<br>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<br>* Recent historical controls will have received care under usual care that existed prior to implementation of an enhanced recovery protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to ERAS protocol | Adherence to ERAS protocol items with # of items achieved (out of 20) | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Median primary inpatient hospital stay associated with surgery episode (# midnight) | 3 years | 
| Re-admissions within 30 days | Median number of re-admissions to any hospital within 30 days of surgery episode per patient | 30 days | 
| Re-operations within 90 days | Median number of unplanned re-operations within 90 days of surgery episode per patient | 90 days | 
| Number of visits to the emergency room within 90 day period | Median number of visits to any emergency room within 90 days of surgery episode per patient | 90 days | 
| Number of 30-day complications | Median number of 30-day complications by Clavien-Dindo classification per patient | 3 years | 
| Number of 90-day complications | Median number of 90-day complications by Clavien-Dindo classification per patient | 3 years | 
| Number of long-term complications within 1 year | Median number of long-term complications per patient | 1 year | 
| Daily IV morphine equivalents | Mean daily IV morphine equivalents (mg/kg) usage during first 3 days after surgery | 3 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enhanced recovery after surgery, urologic reconstruction, pediatric urology, bladder augmentation, Mitrofanoff, Malone antegrade continence enema channel, appendicovesicostomy, ileovesicostomy, appendicocecostomy