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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03245242
Other study ID # 201703081
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


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
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