<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/NCT03290742</url>
  </required_header>
  <id_info>
    <org_study_id>INF1</org_study_id>
    <nct_id>NCT03290742</nct_id>
  </id_info>
  <brief_title>Infection Among Patients Undergoing Radical Cystectomy.</brief_title>
  <official_title>Incidence of and Risk Factors for Perioperative Infection Among Patients Undergoing Radical Cystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pomeranian Medical University Szczecin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pomeranian Medical University Szczecin</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>
      Investigators plan to perform a review of medical records a single urology department to&#xD;
      identify patients with febrile perioperative infection who underwent radical cystectomy and&#xD;
      urinary diversion for bladder cancer from January 2014 to July 2017.&#xD;
&#xD;
      Investigators plan assess a potential variables to find correlation with infections after&#xD;
      surgery.&#xD;
&#xD;
      Characteristics, including age, sex, length of hospital stay, body mass index (BMI),&#xD;
      diabetes, hypertension, estimated glomerular filtration rate (eGFR), preoperative&#xD;
      hydronephrosis, smoking status, neoadjuvant chemotherapy, pathological stage, lymph node&#xD;
      involvement, types of urinary diversion, operative method (open/laparoscopic), operative time&#xD;
      and receipt of a perioperative blood transfusion (PBT) will be asses as potential risk factor&#xD;
      for perioperative infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 4, 2017</start_date>
  <completion_date type="Actual">August 30, 2017</completion_date>
  <primary_completion_date type="Actual">August 20, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with perioperative infection after radical cystectomy.</measure>
    <time_frame>30 days</time_frame>
    <description>A review of medical records in a single urology department will be performed to identified all participants with perioperative infection after radical cystectomy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association between perioperative infection after radical cystectomy and patients' age.</measure>
    <time_frame>30 days</time_frame>
    <description>Logistic regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between perioperative infection after radical cystectomy and sex.</measure>
    <time_frame>30 days</time_frame>
    <description>Logistic regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between perioperative infection after radical cystectomy and length of hospital stay.</measure>
    <time_frame>30 days</time_frame>
    <description>Logistic regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between perioperative infection after radical cystectomy and body mass index.</measure>
    <time_frame>30 days</time_frame>
    <description>Logistic regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between perioperative infection after radical cystectomy and diabetes.</measure>
    <time_frame>30 days</time_frame>
    <description>Logistic regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between perioperative infection after radical cystectomy and hypertension.</measure>
    <time_frame>30 days</time_frame>
    <description>Logistic regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between perioperative infection after radical cystectomy and estimated glomerular filtration rate</measure>
    <time_frame>30 days</time_frame>
    <description>Logistic regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between perioperative infection after radical cystectomy and preoperative hydronephrosis.</measure>
    <time_frame>30 days</time_frame>
    <description>Logistic regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between perioperative infection after radical cystectomy and smoking status.</measure>
    <time_frame>30 days</time_frame>
    <description>Logistic regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between perioperative infection after radical cystectomy and neoadjuvant chemotherapy.</measure>
    <time_frame>30 days</time_frame>
    <description>Logistic regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between perioperative infection after radical cystectomy and pathological stage.</measure>
    <time_frame>30 days</time_frame>
    <description>Logistic regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between perioperative infection after radical cystectomy and lymph node involvement.</measure>
    <time_frame>30 days</time_frame>
    <description>Logistic regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between perioperative infection after radical cystectomy and types of urinary diversion.</measure>
    <time_frame>30 days</time_frame>
    <description>Logistic regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between perioperative infection after radical cystectomy and operative method (open/laparoscopic).</measure>
    <time_frame>30 days</time_frame>
    <description>Logistic regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between perioperative infection after radical cystectomy and operative time.</measure>
    <time_frame>30 days</time_frame>
    <description>Logistic regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between perioperative infection after radical cystectomy and receipt of a perioperative blood transfusion.</measure>
    <time_frame>30 days</time_frame>
    <description>Logistic regression analysis.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">133</enrollment>
  <condition>Cystostomy Infection</condition>
  <arm_group>
    <arm_group_label>Patients without documented infection.</arm_group_label>
    <description>Patients without infection during 30 day follow-up after radical cystectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with documented infection.</arm_group_label>
    <description>Patients with documented any kind of infection (urinary tract infection, blood infection/septic shock, surgical site infection) during 30 day follow-up after radical cystectomy.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who underwent radical cystectomy and urinary diversion for bladder cancer from&#xD;
        January 2014 to July 2017.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent radical cystectomy and urinary diversion for bladder cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  documented infection at the time of radical cystectomy&#xD;
&#xD;
          -  concurrent organ resection such as nephrectomy, nephroureterectomy&#xD;
&#xD;
          -  partial cystectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Urology and Urological Oncology</name>
      <address>
        <city>Szczecin</city>
        <state>West Pomeranian</state>
        <zip>70-111</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 20, 2017</last_update_submitted>
  <last_update_submitted_qc>September 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pomeranian Medical University Szczecin</investigator_affiliation>
    <investigator_full_name>Krystian Kaczmarek</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable 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/NCT03290742
org study id: INF1
nct id: NCT03290742
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigators plan to perform a review of medical records a single urology department to
      identify patients with febrile perioperative infection who underwent radical cystectomy and
      urinary diversion for bladder cancer from January 2014 to July 2017.

      Investigators plan assess a potential variables to find correlation with infections after
      surgery.

      Characteristics, including age, sex, length of hospital stay, body mass index (BMI),
      diabetes, hypertension, estimated glomerular filtration rate (eGFR), preoperative
      hydronephrosis, smoking status, neoadjuvant chemotherapy, pathological stage, lymph node
      involvement, types of urinary diversion, operative method (open/laparoscopic), operative time
      and receipt of a perioperative blood transfusion (PBT) will be asses as potential risk factor
      for perioperative infection.
observational model: Cohort
time perspective: Retrospective
measure: Number of participants with perioperative infection after radical cystectomy.
time frame: 30 days
description: A review of medical records in a single urology department will be performed to identified all participants with perioperative infection after radical cystectomy.
measure: Association between perioperative infection after radical cystectomy and patients' age.
time frame: 30 days
description: Logistic regression analysis.
measure: Association between perioperative infection after radical cystectomy and sex.
time frame: 30 days
description: Logistic regression analysis.
measure: Association between perioperative infection after radical cystectomy and length of hospital stay.
time frame: 30 days
description: Logistic regression analysis.
measure: Association between perioperative infection after radical cystectomy and body mass index.
time frame: 30 days
description: Logistic regression analysis.
measure: Association between perioperative infection after radical cystectomy and diabetes.
time frame: 30 days
description: Logistic regression analysis.
measure: Association between perioperative infection after radical cystectomy and hypertension.
time frame: 30 days
description: Logistic regression analysis.
measure: Association between perioperative infection after radical cystectomy and estimated glomerular filtration rate
time frame: 30 days
description: Logistic regression analysis.
measure: Association between perioperative infection after radical cystectomy and preoperative hydronephrosis.
time frame: 30 days
description: Logistic regression analysis.
measure: Association between perioperative infection after radical cystectomy and smoking status.
time frame: 30 days
description: Logistic regression analysis.
measure: Association between perioperative infection after radical cystectomy and neoadjuvant chemotherapy.
time frame: 30 days
description: Logistic regression analysis.
measure: Association between perioperative infection after radical cystectomy and pathological stage.
time frame: 30 days
description: Logistic regression analysis.
measure: Association between perioperative infection after radical cystectomy and lymph node involvement.
time frame: 30 days
description: Logistic regression analysis.
measure: Association between perioperative infection after radical cystectomy and types of urinary diversion.
time frame: 30 days
description: Logistic regression analysis.
measure: Association between perioperative infection after radical cystectomy and operative method (open/laparoscopic).
time frame: 30 days
description: Logistic regression analysis.
measure: Association between perioperative infection after radical cystectomy and operative time.
time frame: 30 days
description: Logistic regression analysis.
measure: Association between perioperative infection after radical cystectomy and receipt of a perioperative blood transfusion.
time frame: 30 days
description: Logistic regression analysis.
arm group label: Patients without documented infection.
description: Patients without infection during 30 day follow-up after radical cystectomy.
arm group label: Patients with documented infection.
description: Patients with documented any kind of infection (urinary tract infection, blood infection/septic shock, surgical site infection) during 30 day follow-up after radical cystectomy.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Pomeranian Medical University Szczecin
investigator full name: Krystian Kaczmarek
investigator title: Principal Investigator
mesh term: Infections
mesh term: Communicable Diseases
sharing ipd: No