Pediatric Urology Recovery After Surgery Endeavor (PURSUE)
NCT ID: NCT03245242
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
85 participants
OBSERVATIONAL
2017-04-01
2026-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Enhanced Recovery After Surgery
Prospectively enrolled group to receive standardized care under a set ERAS protocol/pathway.
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.
Historical usual surgical care
Recent historical controls will have received care under "usual care" that existed prior to implementation of an enhanced recovery protocol.
Interventions
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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 controls will have received care under "usual care" that existed prior to implementation of an enhanced recovery protocol.
Eligibility Criteria
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Inclusion Criteria
* 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
4 Years
25 Years
ALL
Yes
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Douglas Coplen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
Ann & Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Washington University School of Medicine
St Louis, Missouri, 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
Countries
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References
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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.
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.
Other Identifiers
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201703081
Identifier Type: -
Identifier Source: org_study_id