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Clinical Trials/NCT03245242
NCT03245242
Active, not recruiting
Not Applicable

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

Washington University School of Medicine7 sites in 1 country85 target enrollmentApril 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urologic Surgical Procedures
Sponsor
Washington University School of Medicine
Enrollment
85
Locations
7
Primary Endpoint
Adherence to ERAS protocol
Status
Active, not recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2017
End Date
October 31, 2026
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Adherence to ERAS protocol

Time Frame: 3 years

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

Secondary Outcomes

  • Number of 90-day complications(3 years)
  • Number of visits to the emergency room within 90 day period(90 days)
  • Number of long-term complications within 1 year(1 year)
  • Re-operations within 90 days(90 days)
  • Number of 30-day complications(3 years)
  • Length of stay(3 years)
  • Re-admissions within 30 days(30 days)
  • Daily IV morphine equivalents(3 days after surgery)

Study Sites (7)

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