<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03245242</url>
  </required_header>
  <id_info>
    <org_study_id>201703081</org_study_id>
    <nct_id>NCT03245242</nct_id>
  </id_info>
  <brief_title>Pediatric Urology Recovery After Surgery Endeavor (PURSUE)</brief_title>
  <official_title>Multicenter Pilot and Exploration Study of Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Urologic Reconstructive Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to evaluate an Enhanced Recovery After Surgery (ERAS)&#xD;
      protocol in children and young adults undergoing urologic reconstructive surgery. The&#xD;
      investigators plan to collect data on speed of recovery (how quickly pain improves, length of&#xD;
      time in the hospital, and the need for additional pain control) on patients who receive care&#xD;
      under the ERAS protocol and compare it to historical controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this project is to evaluate Enhanced Recovery After Surgery (ERAS) in the&#xD;
      pediatric setting for participants undergoing intraabdominal urologic reconstruction&#xD;
      procedures. ERAS practices are being implemented in the department independent of research&#xD;
      and this project will allow the investigators to review these practices.&#xD;
&#xD;
      Providers, participants, and family members will complete pre- and post- surgery&#xD;
      questionnaires. These questionnaires are geared to collect demographic information about the&#xD;
      participant and how the surgery affects their life situation. The providers will answer&#xD;
      questions regarding their experience with ERAS.&#xD;
&#xD;
      Evidence-based ERAS principles and procedures are compulsory components of this project.&#xD;
      These will be documented in the medical record and are considered standard of care practice&#xD;
      as part of perioperative patient care.&#xD;
&#xD;
      Data collected from the medical record for each participant will aid in evaluating if&#xD;
      adherence to the ERAS protocol is achieved.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">October 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to ERAS protocol</measure>
    <time_frame>3 years</time_frame>
    <description>Adherence to ERAS protocol items with # of items achieved (out of 20)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>3 years</time_frame>
    <description>Median primary inpatient hospital stay associated with surgery episode (# midnight)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-admissions within 30 days</measure>
    <time_frame>30 days</time_frame>
    <description>Median number of re-admissions to any hospital within 30 days of surgery episode per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-operations within 90 days</measure>
    <time_frame>90 days</time_frame>
    <description>Median number of unplanned re-operations within 90 days of surgery episode per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of visits to the emergency room within 90 day period</measure>
    <time_frame>90 days</time_frame>
    <description>Median number of visits to any emergency room within 90 days of surgery episode per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of 30-day complications</measure>
    <time_frame>3 years</time_frame>
    <description>Median number of 30-day complications by Clavien-Dindo classification per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of 90-day complications</measure>
    <time_frame>3 years</time_frame>
    <description>Median number of 90-day complications by Clavien-Dindo classification per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of long-term complications within 1 year</measure>
    <time_frame>1 year</time_frame>
    <description>Median number of long-term complications per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily IV morphine equivalents</measure>
    <time_frame>3 days after surgery</time_frame>
    <description>Mean daily IV morphine equivalents (mg/kg) usage during first 3 days after surgery</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">85</enrollment>
  <condition>Urologic Surgical Procedures</condition>
  <condition>Urinary Bladder, Neurogenic</condition>
  <condition>Urinary Bladder Diseases</condition>
  <arm_group>
    <arm_group_label>Enhanced Recovery After Surgery</arm_group_label>
    <description>Prospectively enrolled group to receive standardized care under a set ERAS protocol/pathway.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Historical usual surgical care</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced Recovery after Surgery</intervention_name>
    <description>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.</description>
    <arm_group_label>Enhanced Recovery After Surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Historical usual surgical care</intervention_name>
    <description>Recent historical controls will have received care under &quot;usual care&quot; that existed prior to implementation of an enhanced recovery protocol.</description>
    <arm_group_label>Historical usual surgical care</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        There are 2 populations:&#xD;
&#xD;
          1. ERAS patients: a. ages 4-17 and, b. transitional young adult 18-25&#xD;
&#xD;
          2. Historical patients: a. ages 4-17 and, b. transitional young adult 18-25&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Age greater than or equal to 4 or &lt;26 years at time of surgery&#xD;
&#xD;
          -  Undergoing urologic reconstructive surgery that includes primary bowel anastomosis&#xD;
             (i.e., creation of continent ileovesicostomy [Monti], sigmoid Monti channel,&#xD;
             enterocystoplasty)&#xD;
&#xD;
          -  Undergoing urologic reconstructive surgery that includes possible bowel anastomosis&#xD;
             (planned creation of continent appendicovesicostomy [Mitrofanoff] with inability to&#xD;
             use appendix at time of surgery and creation of alternative channel requiring primary&#xD;
             bowel anastomosis)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        • Clinically constipated (defined as Bristol 1 or 2 stools more than once per week, bowel&#xD;
        movement interval &gt; every other day [e.g. only has bowel movement every 3 days, or palpable&#xD;
        stool in &gt; 50% of colon on physical preoperative exam)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kyle Rove, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ann &amp; Robert Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma University Health Science Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>72104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Pittsburgh of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Richmond at Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>January 27, 2023</last_update_submitted>
  <last_update_submitted_qc>January 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>enhanced recovery after surgery</keyword>
  <keyword>urologic reconstruction</keyword>
  <keyword>pediatric urology</keyword>
  <keyword>bladder augmentation</keyword>
  <keyword>Mitrofanoff</keyword>
  <keyword>Malone antegrade continence enema channel</keyword>
  <keyword>appendicovesicostomy</keyword>
  <keyword>ileovesicostomy</keyword>
  <keyword>appendicocecostomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Neurogenic</mesh_term>
    <mesh_term>Urinary Bladder Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03245242
org study id: 201703081
nct id: NCT03245242
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Only
time perspective: Prospective
measure: Adherence to ERAS protocol
time frame: 3 years
description: Adherence to ERAS protocol items with # of items achieved (out of 20)
measure: Length of stay
time frame: 3 years
description: Median primary inpatient hospital stay associated with surgery episode (# midnight)
measure: Re-admissions within 30 days
time frame: 30 days
description: Median number of re-admissions to any hospital within 30 days of surgery episode per patient
measure: Re-operations within 90 days
time frame: 90 days
description: Median number of unplanned re-operations within 90 days of surgery episode per patient
measure: Number of visits to the emergency room within 90 day period
time frame: 90 days
description: Median number of visits to any emergency room within 90 days of surgery episode per patient
measure: Number of 30-day complications
time frame: 3 years
description: Median number of 30-day complications by Clavien-Dindo classification per patient
measure: Number of 90-day complications
time frame: 3 years
description: Median number of 90-day complications by Clavien-Dindo classification per patient
measure: Number of long-term complications within 1 year
time frame: 1 year
description: Median number of long-term complications per patient
measure: Daily IV morphine equivalents
time frame: 3 days after surgery
description: Mean daily IV morphine equivalents (mg/kg) usage during first 3 days after surgery
arm group label: Enhanced Recovery After Surgery
description: Prospectively enrolled group to receive standardized care under a set ERAS protocol/pathway.
arm group label: Historical usual surgical care
description: 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 type: Other
intervention name: Enhanced Recovery after Surgery
description: 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.
arm group label: Enhanced Recovery After Surgery
intervention type: Other
intervention name: Historical usual surgical care
description: Recent historical controls will have received care under "usual care" that existed prior to implementation of an enhanced recovery protocol.
arm group label: Historical usual surgical care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kyle Rove, M.D.
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Urinary Bladder, Neurogenic
mesh term: Urinary Bladder Diseases
sharing ipd: No