Pediatric Urology Recovery After Surgery Endeavor (PURSUE)

Urinary Bladder, Neurogenic Clinical Trial

Official title:

Multicenter Pilot and Exploration Study of Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Urologic Reconstructive Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03245242
• Other study ID #: 201703081
• Status: Active, not recruiting
• Start date: April 1, 2017
• Est. completion date: October 31, 2024

Study information

• Verified date: October 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 85
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Ann & Robert Lurie Children's Hospital of Chicago	Chicago	Illinois
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	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to ERAS protocol	Adherence to ERAS protocol items with # of items achieved (out of 20)	3 years
Secondary	Length of stay	Median primary inpatient hospital stay associated with surgery episode (# midnight)	3 years
Secondary	Re-admissions within 30 days	Median number of re-admissions to any hospital within 30 days of surgery episode per patient	30 days
Secondary	Re-operations within 90 days	Median number of unplanned re-operations within 90 days of surgery episode per patient	90 days
Secondary	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	90 days
Secondary	Number of 30-day complications	Median number of 30-day complications by Clavien-Dindo classification per patient	3 years
Secondary	Number of 90-day complications	Median number of 90-day complications by Clavien-Dindo classification per patient	3 years
Secondary	Number of long-term complications within 1 year	Median number of long-term complications per patient	1 year
Secondary	Daily IV morphine equivalents	Mean daily IV morphine equivalents (mg/kg) usage during first 3 days after surgery	3 days after surgery