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Pediatric Urology Recovery After Surgery Endeavor (PURSUE)

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ClinicalTrials.gov Identifier: NCT03245242
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date July 28, 2017
First Posted Date August 10, 2017
Last Update Posted Date March 28, 2019
Actual Study Start Date April 1, 2017
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 7, 2017)
Adherence to ERAS protocol [ Time Frame: 3 years ]
Adherence to ERAS protocol items with # of items achieved (out of 20)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03245242 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 23, 2017)
  • Length of stay [ Time Frame: 3 years ]
    Median primary inpatient hospital stay associated with surgery episode (# midnight)
  • 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 complications 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
Original Secondary Outcome Measures
 (submitted: August 7, 2017)
  • Length of stay [ Time Frame: 3 years ]
    Median primary inpatient hospital stay associated with surgery episode (# midnight)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pediatric Urology Recovery After Surgery Endeavor (PURSUE)
Official Title Multicenter Pilot and Exploration Study of Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Urologic Reconstructive Surgery
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Urologic Surgical Procedures
  • Urinary Bladder, Neurogenic
  • Urinary Bladder Diseases
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.
  • 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.
Study Groups/Cohorts
  • Enhanced Recovery After Surgery
    Prospectively enrolled group to receive standardized care under a set ERAS protocol/pathway.
    Intervention: Other: Enhanced Recovery after Surgery
  • 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.
    Intervention: Other: Historical usual surgical care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 7, 2017)
85
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 30, 2021
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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)

Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Gino Vricella, M.D. 314-454-6034 vricellag@wustl.edu
Contact: Kyle Rove, M.D. 314-454-6034 rovek@wustl.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03245242
Other Study ID Numbers 201703081
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor Washington University School of Medicine
Collaborators Not Provided
Investigators
Principal Investigator: Kyle Rove, M.D. Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date March 2019