xml: <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/NCT06032910</url>
    </required_header>
    <id_info>
      <org_study_id>Mesh_RACE</org_study_id>
      <nct_id>NCT06032910</nct_id>
    </id_info>
    <brief_title>Surgical Mesh in Radical Cystectomy to Prevent Parastomal Hernias</brief_title>
    <official_title>The Use of Surgical Mesh in Open Radical Cystectomy With Ileal Conduit Urinary Diversion to Prevent Parastomal Hernias</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Charles University, Czech Republic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Charles University, Czech Republic</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>
        Radical cystectomy with ileal conduit urinary diversion serves as a foundational curative&#xD;
        treatment strategy for selected patients afflicted with urothelial carcinoma of the bladder.&#xD;
        Parastomal hernia after this procedure is an underestimated and undertreated clinical entity,&#xD;
        which heavily impairs patients' quality of life due to symptoms of pain, leakage, application&#xD;
        or skin problems. There is little evidence about prophylactic mesh placement for parastomal&#xD;
        hernia prevention. In this study we examine the use of meshes during radical cystectomy and&#xD;
        compare them with a control group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Radical cystectomy with ileal conduit diversion is a procedure possible with complications. A&#xD;
        primary stoma-related complication is the parastomal hernia (PH), which presents significant&#xD;
        challenges to both the medical community and the patient. PH is classically defined as the&#xD;
        protrusion of abdominal contents via the abdominal wall, especially in the direct vicinity of&#xD;
        a stoma, whether it be a colostomy, ileostomy, or ileal conduit stoma. The incidence of PH&#xD;
        post ileal conduit urinary diversion is especially concerning, with reports estimating its&#xD;
        occurrence at around 17%. This data only emphasizes the need to reevaluate and optimize&#xD;
        surgical treatments for PH, particularly as, in many cases, management strategies are&#xD;
        extrapolated from experiences with colostomies or ileostomies. Notably, PHs are often&#xD;
        described after these procedures rather than RC with ileal conduit urinary diversion. Further&#xD;
        complicating the issue is the fact that estimates suggest around 30% of patients develop a PH&#xD;
        within 12 months post any type of stoma site surgery. For those undergoing ileal conduit&#xD;
        urinary diversion specifically, recurrence rates following PH repair can be alarmingly high,&#xD;
        with figures as steep as 69% within a year.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Parastomal hernia</measure>
      <time_frame>12 months</time_frame>
      <description>Incidence after surgery</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Bladder Cancer</condition>
    <condition>Hernia</condition>
    <condition>Ileal Conduit</condition>
    <arm_group>
      <arm_group_label>Study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients who receive prophylactic mesh during the surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Surgical mesh</intervention_name>
      <description>Prophylactic synthetic non-absorbable keyhole mesh placement upon construction of ileal conduit.</description>
      <arm_group_label>Study group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  muscle-invasive or high-risk non-muscle-invasive bladder cancer patients&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  different than surgical therapy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Pavel Navratil, M.D.</last_name>
      <phone>00420495833378</phone>
      <email>pavel.navratil2@fnhk.cz</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Hospital Hradec Kralove</name>
        <address>
          <city>Hradec Králové</city>
          <zip>50005</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Pavel Navratil, M.D.</last_name>
        <phone>00420495833378</phone>
        <email>pavel.navratil2@fnhk.cz</email>
      </contact>
    </location>
    <location_countries>
      <country>Czechia</country>
    </location_countries>
    <link>
      <url>https://www.fnhk.cz/urol</url>
      <description>Department's website</description>
    </link>
    <verification_date>January 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>radical cystectomy</keyword>
    <keyword>ileal conduit</keyword>
    <keyword>parastomal hernia</keyword>
    <keyword>mesh</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hernia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032910
  org study id: Mesh_RACE
  nct id: NCT06032910
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Radical cystectomy with ileal conduit urinary diversion serves as a foundational curative
        treatment strategy for selected patients afflicted with urothelial carcinoma of the bladder.
        Parastomal hernia after this procedure is an underestimated and undertreated clinical entity,
        which heavily impairs patients' quality of life due to symptoms of pain, leakage, application
        or skin problems. There is little evidence about prophylactic mesh placement for parastomal
        hernia prevention. In this study we examine the use of meshes during radical cystectomy and
        compare them with a control group.
  Radical cystectomy with ileal conduit diversion is a procedure possible with complications. A
        primary stoma-related complication is the parastomal hernia (PH), which presents significant
        challenges to both the medical community and the patient. PH is classically defined as the
        protrusion of abdominal contents via the abdominal wall, especially in the direct vicinity of
        a stoma, whether it be a colostomy, ileostomy, or ileal conduit stoma. The incidence of PH
        post ileal conduit urinary diversion is especially concerning, with reports estimating its
        occurrence at around 17%. This data only emphasizes the need to reevaluate and optimize
        surgical treatments for PH, particularly as, in many cases, management strategies are
        extrapolated from experiences with colostomies or ileostomies. Notably, PHs are often
        described after these procedures rather than RC with ileal conduit urinary diversion. Further
        complicating the issue is the fact that estimates suggest around 30% of patients develop a PH
        within 12 months post any type of stoma site surgery. For those undergoing ileal conduit
        urinary diversion specifically, recurrence rates following PH repair can be alarmingly high,
        with figures as steep as 69% within a year.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Parastomal hernia
  time frame: 12 months
  description: Incidence after surgery
  arm group label: Study group
  arm group type: Experimental
  description: Patients who receive prophylactic mesh during the surgery.
  intervention type: Device
  intervention name: Surgical mesh
  description: Prophylactic synthetic non-absorbable keyhole mesh placement upon construction of ileal conduit.
  arm group label: Study group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Pavel Navratil, M.D.
  phone: 00420495833378
  email: pavel.navratil2@fnhk.cz
  facility: 
  status: Recruiting
  contact: 
  country: Czechia
  url: https://www.fnhk.cz/urol
  description: Department's website
  responsible party type: Sponsor
  mesh term: Hernia
  sharing ipd: No