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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Recovery After Surgery | Prospectively enrolled group to receive standardized care under a set ERAS protocol/pathway. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Recovery after Surgery | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to ERAS protocol | Adherence to ERAS protocol items with # of items achieved (out of 20) | 3 years |
| 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 |
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Inclusion criteria:
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)](streamdown:incomplete-link)
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There are 2 populations:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Coplen, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States | ||
| Ann & Robert Lurie Children's Hospital of Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36167478 | Derived | Moore RP, Burjek NE, Brockel MA, Strine AC, Acks A, Boxley PJ, Chidambaran V, Vricella GJ, Chu DI, Sankaran-Raval M, Zee RS, Cladis FP, Chaudhry R, O'Reilly-Shah VN, Ahn JJ, Rove KO; PURSUE Study Group. Evaluating the role for regional analgesia in children with spina bifida: a retrospective observational study comparing the efficacy of regional versus systemic analgesia protocols following major urological surgery. Reg Anesth Pain Med. 2023 Jan;48(1):29-36. doi: 10.1136/rapm-2022-103823. Epub 2022 Sep 27. | |
| 33234633 |
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|
| Historical usual surgical care | Other | Recent historical controls will have received care under "usual care" that existed prior to implementation of an enhanced recovery protocol. |
|
| 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 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Oklahoma University Health Science Center | Oklahoma City | Oklahoma | 72104 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Children's Hospital of Richmond at Virginia Commonwealth University | Richmond | Virginia | 23221 | United States |
| Derived |
| Rove KO, Strine AC, Wilcox DT, Vricella GJ, Welch TP, VanderBrink B, Chu DI, Chaudhry R, Zee RS, Brockel MA; PURSUE Study group. Design and development of the Pediatric Urology Recovery After Surgery Endeavor (PURSUE) multicentre pilot and exploratory study. BMJ Open. 2020 Nov 23;10(11):e039035. doi: 10.1136/bmjopen-2020-039035. |
| ID | Term |
|---|---|
| D001750 | Urinary Bladder, Neurogenic |
| D001745 | Urinary Bladder Diseases |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000080482 | Enhanced Recovery After Surgery |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D013514 | Surgical Procedures, Operative |
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