Urinary Bladder, Neurogenic Clinical Trial
Official title:
Multicenter Pilot and Exploration Study of Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Urologic Reconstructive Surgery
Verified date | October 2023 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 85 |
Est. completion date | October 31, 2024 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 25 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | 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 | Oklahoma University Health Science Center | Oklahoma City | Oklahoma |
United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
United States | Children's Hospital of Richmond at Virginia Commonwealth University | Richmond | Virginia |
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence to ERAS protocol | Adherence to ERAS protocol items with # of items achieved (out of 20) | 3 years | |
Secondary | Length of stay | Median primary inpatient hospital stay associated with surgery episode (# midnight) | 3 years | |
Secondary | Re-admissions within 30 days | Median number of re-admissions to any hospital within 30 days of surgery episode per patient | 30 days | |
Secondary | Re-operations within 90 days | Median number of unplanned re-operations within 90 days of surgery episode per patient | 90 days | |
Secondary | 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 | |
Secondary | Number of 30-day complications | Median number of 30-day complications by Clavien-Dindo classification per patient | 3 years | |
Secondary | Number of 90-day complications | Median number of 90-day complications by Clavien-Dindo classification per patient | 3 years | |
Secondary | Number of long-term complications within 1 year | Median number of long-term complications per patient | 1 year | |
Secondary | Daily IV morphine equivalents | Mean daily IV morphine equivalents (mg/kg) usage during first 3 days after surgery | 3 days after surgery |
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