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Pediatric Urology Recovery After Surgery Endeavor (PURSUE)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT03245242
First received: July 28, 2017
Last updated: August 7, 2017
Last verified: August 2017
  Purpose
The purpose of this research study is to evaluate procedures implemented to potentially speed up recovery after urologic surgery. We are interested in speed of recovery (how quickly pain improves, length of time in the hospital, and the need for additional pain control).

Condition Intervention
Urologic Surgical Procedures Urinary Bladder, Neurogenic Urinary Bladder Diseases Other: Enhanced Recovery after Surgery Other: Historical usual surgical care

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multicenter Pilot and Exploration Study of Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Urologic Reconstructive Surgery

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Adherence to ERAS protocol [ Time Frame: 3 years ]
    Adherence to ERAS protocol items with # of items achieved (out of 20)


Secondary Outcome Measures:
  • Length of stay [ Time Frame: 3 years ]
    Median primary inpatient hospital stay associated with surgery episode (# midnights)

  • Re-admissions within 30 days [ Time Frame: 30 days ]
    Median number of re-admissions to any hospital within 30 days of surgery episode per patient

  • Re-operations within 90 days [ Time Frame: 90 days ]
    Median number of unplanned re-operations within 90 days of surgery episode per patient

  • Number of visits to the emergency room within 90 day period [ Time Frame: 90 days ]
    Median number of visits to any emergency room within 90 days of surgery episode per patient

  • Number of 30-day complications [ Time Frame: 3 years ]
    Median number of 30-day compllications by Clavien-Dindo classification per patient

  • Number of 90-day complications [ Time Frame: 3 years ]
    Median number of 90-day complications by Clavien-Dindo classification per patient

  • Number of long-term complications within 1 year [ Time Frame: 1 year ]
    Median number of long-term complications per patient

  • Daily IV morphine equivalents [ Time Frame: 3 days after surgery ]
    Mean daily IV morphine equivalents (mg/kg) usage during first 3 days after surgery


Estimated Enrollment: 85
Actual Study Start Date: April 1, 2017
Estimated Study Completion Date: April 30, 2020
Estimated Primary Completion Date: April 30, 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Enhanced Recovery After Surgery
Prospectively enrolled group to receive standardized care under a set ERAS protocol/pathway.
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 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.
Other: Historical usual surgical care
Recent historical controls will have received care under "usual care" that existed prior to implementation of an enhanced recovery protocol.

Detailed Description:

The purpose of this project is to evaluate Enhanced Recovery After Surgery (ERAS) in the pediatric setting for patients undergoing intraabdominal urologic reconstruction procedures. ERAS practices are being implemented in the department independent of research, this project will allow us to review these practices.

The providers and the patient/family members will complete pre and post surgery questionnaires. These questionnaires are geared to collect demographic information about the patient 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 basically standard of care methodologies.

Data collected from the medical record for each subject will aid in evaluating if adherence to the ERAS protocol is achieved.

  Eligibility

Ages Eligible for Study:   4 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03245242

Contacts
Contact: Gino Vricella, M.D. 314-454-6034 vricellag@wustl.edu
Contact: Kyle Rove, M.D. 314-454-6034 rovek@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kyle Rove, M.D.    314-454-6034    rovek@wustl.edu   
Contact: Gino Vricella, M.D.    314-454-6034    vricellag@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Kyle Rove, M.D. Human Research Protection Office (HRPO)
  More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03245242     History of Changes
Other Study ID Numbers: 201703081
Study First Received: July 28, 2017
Last Updated: August 7, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:
enhanced recovery after surgery
urologic reconstruction
pediatric urology
bladder augmentation
Mitrofanoff
Malone antegrade continence enema channel
appendicovesicostomy
ileovesicostomy
appendicocecostomy

Additional relevant MeSH terms:
Urinary Bladder Diseases
Urinary Bladder, Neurogenic
Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2017