Pediatric Urology Recovery After Surgery Endeavor (PURSUE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03245242|
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : February 13, 2018
|Condition or disease||Intervention/treatment|
|Urologic Surgical Procedures Urinary Bladder, Neurogenic Urinary Bladder Diseases||Other: Enhanced Recovery after Surgery Other: Historical usual surgical care|
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.
|Study Type :||Observational|
|Estimated Enrollment :||85 participants|
|Official Title:||Multicenter Pilot and Exploration Study of Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Urologic Reconstructive Surgery|
|Actual Study Start Date :||April 1, 2017|
|Estimated Primary Completion Date :||April 30, 2019|
|Estimated Study Completion Date :||April 30, 2020|
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.
- 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 (# midnight)
- 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 complications 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245242
|Contact: Gino Vricella, M.D.||email@example.com|
|Contact: Kyle Rove, M.D.||firstname.lastname@example.org|
|United States, Colorado|
|Children's Hospital Colorado||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Sheryl Holbrook 720-777-2678 Sheryl.Holbrook@childrenscolorado.org|
|Contact: Duncan Wilcox, MD 720-777-1234 email@example.com|
|Principal Investigator: Duncan Wilcox, MD|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Kyle Rove, M.D. 314-454-6034 firstname.lastname@example.org|
|Contact: Gino Vricella, M.D. 314-454-6034 email@example.com|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Marion E Schulte 513-803-9093 firstname.lastname@example.org|
|Contact: Andrew Strine, MD (513) 636-4975 email@example.com|
|Sub-Investigator: Andrew Strine, MD|
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh of UPMC||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15224|
|Contact: Jennifer Clayton 412-692-7949 Jennifer.firstname.lastname@example.org|
|Contact: Rajeev Chaudhry, MD 412-692-7466 email@example.com|
|Sub-Investigator: Rajeev Chaudhry, MD|
|Principal Investigator:||Kyle Rove, M.D.||Washington University School of Medicine|