Pediatric Urology Recovery After Surgery Endeavor (PURSUE)
Multicenter Pilot and Exploration Study of Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Urologic Reconstructive Surgery
1 other identifier
observational
85
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2017
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 28, 2017
CompletedFirst Posted
Study publicly available on registry
August 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
December 26, 2025
December 1, 2025
9.6 years
July 28, 2017
December 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence to ERAS protocol
Adherence to ERAS protocol items with # of items achieved (out of 20)
3 years
Secondary Outcomes (8)
Length of stay
3 years
Re-admissions within 30 days
30 days
Re-operations within 90 days
90 days
Number of visits to the emergency room within 90 day period
90 days
Number of 30-day complications
3 years
- +3 more secondary outcomes
Study Arms (2)
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.
Interventions
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.
Recent historical controls will have received care under "usual care" that existed prior to implementation of an enhanced recovery protocol.
Eligibility Criteria
There are 2 populations: 1. ERAS patients: a. ages 4-17 and, b. transitional young adult 18-25 2. Historical patients: a. ages 4-17 and, b. transitional young adult 18-25
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Ann & Robert Lurie Children's Hospital of Chicago
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
Related Publications (2)
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.
PMID: 36167478DERIVEDRove 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.
PMID: 33234633DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas Coplen, M.D.
Washington University School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2017
First Posted
August 10, 2017
Study Start
April 1, 2017
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
December 26, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share