<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/NCT04406168</url>
  </required_header>
  <id_info>
    <org_study_id>urinary diversions outcomes</org_study_id>
    <nct_id>NCT04406168</nct_id>
  </id_info>
  <brief_title>Assessment of Urinary Diversions Outcomes Post Radical Cystectomy in Asyut University Urology Hospital</brief_title>
  <official_title>Assessment of Urinary Diversions Outcomes Post Radical Cystectomy in Asyut University Urology Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Radical cystectomy (RC) for bladder cancer requires reconstruction of the lower urinary&#xD;
      tract. Both continent and incontinent diversions are available for urinary reconstruction&#xD;
      after RC. Types of urinary diversions include ( ileal conduit, uretero-cutaneous,&#xD;
      ureterosigmoidostomy and orthotopic bladder) The decision process is complex and involves&#xD;
      consideration of issues related to cancer stage, patient comorbidities, treatment needs, and&#xD;
      patient desires related to Quality of life and intraoperative findings. Outcomes of urinary&#xD;
      diversions include 1- survival rate (cancer specific or overall survival). 2- Oncological&#xD;
      failure (local, distant or LNs). 3- Complications (perioperative, intraoperative or&#xD;
      post-operative).&#xD;
&#xD;
      In this study, all these outcomes will be analyzed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2022</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of patients presented by complications</measure>
    <time_frame>1 year post operative</time_frame>
    <description>such as (change from baseline of the SCR - urinary tract infections - stone formation - stricture at site of anastomosis or stromal stenosis )</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of patients developed recurrence</measure>
    <time_frame>1 year post operative</time_frame>
    <description>recurrence of cancer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survival rate (overall survival &amp; cancer specific)</measure>
    <time_frame>1 year post operative</time_frame>
    <description>patient live post operative</description>
  </primary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Bladder Cancer</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>urinary diversion</intervention_name>
    <description>follow up outcomes of urinary diversion</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All cases that fulfil the selection criteria that have been admitted in Asyut university&#xD;
        urology hospital (non probability sample size) with expected size of 40 patients starting&#xD;
        from 01/01/2013 to1/05/2020.&#xD;
&#xD;
        Additionally, the competence of follow-up will be approved by imaging and medical records.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  * All patients underwent radical cystectomy more than 1 year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  incomplete data&#xD;
&#xD;
          -  patients underwent RC outside urology department and presented for treatment of&#xD;
             complications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>salah s abdelhafez</last_name>
    <role>Study Director</role>
    <affiliation>prof</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>islam m abdellah</last_name>
    <phone>+201090088672</phone>
    <email>islam01183@med.au.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Assiut</city>
        <state>Elgam3a</state>
        <zip>11174</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>tarek m elgamaal</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 10, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Islam Mahmoud Abdellah</investigator_full_name>
    <investigator_title>resident of urology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04406168
org study id: urinary diversions outcomes
nct id: NCT04406168
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Radical cystectomy (RC) for bladder cancer requires reconstruction of the lower urinary
      tract. Both continent and incontinent diversions are available for urinary reconstruction
      after RC. Types of urinary diversions include ( ileal conduit, uretero-cutaneous,
      ureterosigmoidostomy and orthotopic bladder) The decision process is complex and involves
      consideration of issues related to cancer stage, patient comorbidities, treatment needs, and
      patient desires related to Quality of life and intraoperative findings. Outcomes of urinary
      diversions include 1- survival rate (cancer specific or overall survival). 2- Oncological
      failure (local, distant or LNs). 3- Complications (perioperative, intraoperative or
      post-operative).

      In this study, all these outcomes will be analyzed.
observational model: Cohort
time perspective: Retrospective
measure: Rate of patients presented by complications
time frame: 1 year post operative
description: such as (change from baseline of the SCR - urinary tract infections - stone formation - stricture at site of anastomosis or stromal stenosis )
measure: Rate of patients developed recurrence
time frame: 1 year post operative
description: recurrence of cancer
measure: Survival rate (overall survival & cancer specific)
time frame: 1 year post operative
description: patient live post operative
intervention type: Procedure
intervention name: urinary diversion
description: follow up outcomes of urinary diversion
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
last name: salah s abdelhafez
role: Study Director
affiliation: prof
last name: islam m abdellah
phone: +201090088672
email: islam01183@med.au.edu.eg
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Islam Mahmoud Abdellah
investigator title: resident of urology
mesh term: Urinary Bladder Neoplasms
sharing ipd: Undecided