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Active, not recruitingNCT03245242Updated Dec 26, 2025

Pediatric Urology Recovery After Surgery Endeavor (PURSUE)

An observational study in Urologic Surgical Procedures, Urinary Bladder, Neurogenic and Urinary Bladder Diseases, sponsored by Washington University School of Medicine. Active, not recruiting at 7 sites in United States. Open to participants aged 4 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-26.

Sponsored by Washington University School of Medicine · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
85
Ages
4 Years to 25 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Urologic Surgical Procedures
  • Urinary Bladder, Neurogenic
  • Urinary Bladder Diseases

Keywords

  • enhanced recovery after surgery
  • urologic reconstruction
  • pediatric urology
  • bladder augmentation
  • Mitrofanoff
  • Malone antegrade continence enema channel
  • appendicovesicostomy
  • ileovesicostomy
  • appendicocecostomy
03

Who can participate

Ages eligible
4 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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)
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
85 participants (estimated)
Patient registry
No

Groups and cohorts

  • Enhanced Recovery After Surgery

    Prospectively enrolled group to receive standardized care under a set ERAS protocol/pathway.

    Other: Enhanced Recovery after Surgery

  • 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

Interventions

  • OtherEnhanced 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.

  • OtherHistorical usual surgical care

    Recent historical controls will have received care under "usual care" that existed prior to implementation of an enhanced recovery protocol.

05

What researchers measure

Primary outcomes

  1. Adherence to ERAS protocol

    Adherence to ERAS protocol items with # of items achieved (out of 20)

    Time frame: 3 years

Secondary outcomes

  1. Length of stay

    Median primary inpatient hospital stay associated with surgery episode (# midnight)

    Time frame: 3 years

  2. Re-admissions within 30 days

    Median number of re-admissions to any hospital within 30 days of surgery episode per patient

    Time frame: 30 days

  3. Re-operations within 90 days

    Median number of unplanned re-operations within 90 days of surgery episode per patient

    Time frame: 90 days

  4. 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

    Time frame: 90 days

  5. Number of 30-day complications

    Median number of 30-day complications by Clavien-Dindo classification per patient

    Time frame: 3 years

  6. Number of 90-day complications

    Median number of 90-day complications by Clavien-Dindo classification per patient

    Time frame: 3 years

  7. Number of long-term complications within 1 year

    Median number of long-term complications per patient

    Time frame: 1 year

  8. Daily IV morphine equivalents

    Mean daily IV morphine equivalents (mg/kg) usage during first 3 days after surgery

    Time frame: 3 days after surgery

06

Study locations

7 sites
  • 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
07

References and documents

Publications

  • 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. PubMed 36167478 ↗
  • 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. PubMed 33234633 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03245242
Lead sponsor
Washington University School of Medicine
Responsible party
Sponsor
First posted
Aug 10, 2017
Start date
Apr 1, 2017
Primary completion
Oct 31, 2026 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Dec 26, 2025

Study contacts

Douglas Coplen, M.D.
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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