Pediatric Urology Recovery After Surgery Endeavor (PURSUE)

The Washington University

Status: Active, not recruiting

Conditions: Urologic Surgical Procedures; Urinary Bladder Diseases; Urinary Bladder, Neurogenic

Treatments: Other: Enhanced Recovery after Surgery; Other: Historical usual surgical care

Study type: Observational

Funder types: Other

Identifiers

NCT03245242

201703081

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 estimated patients

Sex: All

Ages: 4 to 25 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

85 participants in 2 patient groups

Enhanced Recovery After Surgery

Description:

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

Treatment:

Other: Enhanced Recovery after Surgery

Historical usual surgical care

Description:

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.

Treatment:

Other: Historical usual surgical care