<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/NCT03029663</url>
  </required_header>
  <id_info>
    <org_study_id>12/2016</org_study_id>
    <nct_id>NCT03029663</nct_id>
  </id_info>
  <brief_title>Complications of Transurethral Resection of the Bladder Tumour</brief_title>
  <acronym>ComTUR</acronym>
  <official_title>Complications of Transurethral Resection of the Bladder Tumour: A Prospective Analysis of Incidence and Predictive Factors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <brief_summary>
    <textblock>
      This is a prospective study enrolling consecutive patients who undergo transurethral&#xD;
      resection of the bladder tumour (TURBT) aimed at determination of a safety of the procedure.&#xD;
      Study end-points are incidence, severity and predictive factors of surgical complications.&#xD;
      The study secondary aim is a validation of Clavien Dindo scoring system for reporting&#xD;
      complication of TURBT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Complications rate</measure>
    <time_frame>30 days postop</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications severity</measure>
    <time_frame>30 days postop</time_frame>
    <description>Severity of surgical complications according to Clavien-Dindo classification</description>
  </secondary_outcome>
  <enrollment type="Actual">983</enrollment>
  <condition>Bladder Cancer</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transurethral resection of the bladder tumour</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients undergoing TURBT&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary or recurrent bladder tumour&#xD;
&#xD;
          -  informed consent to undergo the surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of Warsaw, Dept. of Urology</name>
      <address>
        <city>Warsaw</city>
        <zip>02005</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>December 27, 2018</last_update_submitted>
  <last_update_submitted_qc>December 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bladder cancer</keyword>
  <keyword>postoperative complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03029663
org study id: 12/2016
nct id: NCT03029663
lead sponsor: 
This is a prospective study enrolling consecutive patients who undergo transurethral
      resection of the bladder tumour (TURBT) aimed at determination of a safety of the procedure.
      Study end-points are incidence, severity and predictive factors of surgical complications.
      The study secondary aim is a validation of Clavien Dindo scoring system for reporting
      complication of TURBT.
observational model: Cohort
time perspective: Prospective
measure: Complications rate
time frame: 30 days postop
measure: Complications severity
time frame: 30 days postop
description: Severity of surgical complications according to Clavien-Dindo classification
intervention type: Procedure
intervention name: Transurethral resection of the bladder tumour
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms