Urinary Bladder Diseases, Urinary Bladder, Neurogenic, Urologic Surgical Procedures
Conditions
Keywords
enhanced recovery after surgery, urologic reconstruction, pediatric urology, bladder augmentation, Mitrofanoff, Malone antegrade continence enema channel, appendicovesicostomy, ileovesicostomy, appendicocecostomy
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.
Interventions
OTHEREnhanced 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.
OTHERHistorical usual surgical care
Recent historical controls will have received care under usual care that existed prior to implementation of an enhanced recovery protocol.
Sponsors
Washington University School of Medicine
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to 25 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to ERAS protocol | 3 years | Adherence to ERAS protocol items with # of items achieved (out of 20) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Re-admissions within 30 days | 30 days | Median number of re-admissions to any hospital within 30 days of surgery episode per patient |
| Re-operations within 90 days | 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 | 90 days | Median number of visits to any emergency room within 90 days of surgery episode per patient |
| Length of stay | 3 years | Median primary inpatient hospital stay associated with surgery episode (# midnight) |
| Number of 90-day complications | 3 years | Median number of 90-day complications by Clavien-Dindo classification per patient |
| Number of long-term complications within 1 year | 1 year | Median number of long-term complications per patient |
| Daily IV morphine equivalents | 3 days after surgery | Mean daily IV morphine equivalents (mg/kg) usage during first 3 days after surgery |
| Number of 30-day complications | 3 years | Median number of 30-day complications by Clavien-Dindo classification per patient |
Countries
United States
Outcome results
None listed