Clinical trial NCT03245242: Pediatric Urology Recovery After Surgery Endeavor (PURSUE)
Official title: Multicenter Pilot and Exploration Study of Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Urologic Reconstructive Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: 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
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 85
Sex: ALL
Minimum age (years): 4
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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:

• 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)

Primary outcomes:
measure: Adherence to ERAS protocol
timeFrame: 3 years
Secondary outcomes:
measure: Length of stay
timeFrame: 3 years
measure: Re-admissions within 30 days
timeFrame: 30 days
measure: Re-operations within 90 days
timeFrame: 90 days
measure: Number of visits to the emergency room within 90 day period
timeFrame: 90 days
measure: Number of 30-day complications
timeFrame: 3 years
measure: Number of 90-day complications
timeFrame: 3 years
measure: Number of long-term complications within 1 year
timeFrame: 1 year
measure: Daily IV morphine equivalents
timeFrame: 3 days after surgery
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Chicago
country: United States
facility: Ann & Robert Lurie Children's Hospital of Chicago
state: Illinois
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Health Science Center
state: Oklahoma
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Richmond
country: United States
facility: Children's Hospital of Richmond at Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Washington University School of Medicine
name: Kyle Rove, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.