<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/NCT03835351</url>
  </required_header>
  <id_info>
    <org_study_id>19-070</org_study_id>
    <nct_id>NCT03835351</nct_id>
  </id_info>
  <brief_title>Urinary Retention After Laparoscopic Inguinal Hernia Repair: Comparing the Use of the Intraoperative Urinary Catheter</brief_title>
  <official_title>Urinary Retention After Laparoscopic Inguinal Hernia Repair: A Randomized Controlled Trial Comparing Intraoperative Urinary Catheter Versus no Catheter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a randomized controlled study which will compare the rate of post-operative&#xD;
      urinary retention after laparoscopic inguinal hernia repair between patients who receive an&#xD;
      intra-operative urinary catheter and those who do not. The primary aim of the study is to&#xD;
      determine if the use of intra-operative urinary catheter reduces the incidence of&#xD;
      post-operative urinary retention after laparoscopic inguinal hernia repair. Specific patient&#xD;
      inclusion criteria include all patients aged 18 years or older presenting for an elective&#xD;
      unilateral or bilateral inguinal hernia repair, who are able to tolerate general anesthesia&#xD;
      and are considered eligible to have a hernia repair through a laparoscopic approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An inguinal hernia repair is a common outpatient procedure with a low rate of morbidity. One&#xD;
      well-recognized complication of this operation is post-operative urinary retention (PUR),&#xD;
      which is a failure of spontaneous voiding requiring insertion of a urinary catheter. The&#xD;
      reported incidence of PUR ranges between 0.4 and 3% of open tension-free repairs. For&#xD;
      laparoscopic inguinal hernia repairs that range is between 1 and 22. Since no randomized&#xD;
      controlled trials have evaluated PUR as the primary outcome exist in literature, there is no&#xD;
      consensus on whether catheter use aids in minimizing post-operative urinary retention.&#xD;
      Routine use of intraoperative catheterization increases the risk of urethral trauma,&#xD;
      catheter-associated infections and bladder damage leading to increased cost of care and&#xD;
      potential patient morbidity. On the other hand, PUR is associated with additional procedures,&#xD;
      such as catheterization, which may delay hospital discharge or increase the length of stay&#xD;
      and cause patient discomfort. This work aims to study the effect of intraoperative catheters&#xD;
      on PUR and whether the aforementioned risks associated with this procedure are justified.&#xD;
&#xD;
      We hypothesize that the use of intra-operative urinary catheter reduces the incidence of&#xD;
      postoperative urinary retention after laparoscopic inguinal hernia repair, thus justifying&#xD;
      the potential complications associated with intra-operative catheter insertion.&#xD;
&#xD;
      All patients will be asked to void in the pre-operative area prior to going into the&#xD;
      operating room. Patients will be operated in the supine, and slight Trendelenburg position&#xD;
      (15º degrees), with arms tucked along the body. The procedure will be performed under general&#xD;
      anesthesia. After induction of anesthesia, randomization will occur. It will be performed&#xD;
      according to a computer-generated block randomization scheme. The randomization will be&#xD;
      stratified for unilateral or bilateral hernias. Antibiotic prophylaxis will be performed&#xD;
      according to institutional protocol. Pharmacological prophylaxis of venous thromboembolic&#xD;
      events is usually not necessary for general laparoscopic inguinal hernia repair. Although, if&#xD;
      deemed necessary, this will be performed per Surgical Care Improvement Project (SCIP)&#xD;
      protocol and will not be considered a protocol deviation. Skin preparation and hair removal&#xD;
      will be performed per SCIP protocol. All necessary materials, including the urine&#xD;
      catheterization kit, will be available in the operative room before the start of the&#xD;
      procedure.&#xD;
&#xD;
      The Americas Hernia Society Quality Collaborative (AHSQC) registry will serve as the main&#xD;
      platform for data collection. Registry-based trials use data available in a preexisting&#xD;
      database to increase the efficiency of performing RCTs, decreasing the high cost and&#xD;
      logistical challenges associated with operationalizing this type of research. Post-operative&#xD;
      urinary retention will be defined as post-operative failure to void requiring straight&#xD;
      catheterization, placement of an indwelling catheter or return to the emergency department&#xD;
      due to failure to void after discharge from the hospital. Bladder scanning, its timing and&#xD;
      specific criteria for placement of urinary catheter will be determined by the standard&#xD;
      policies of each institution where the surgery was performed and the surgeon.&#xD;
&#xD;
      Specific Aim #1: To determine if the use of intra-operative urinary catheter reduces the&#xD;
      incidence of postoperative urinary retention after laparoscopic inguinal hernia repair. This&#xD;
      will be assessed by comparing the PUR rates between the two study groups.&#xD;
&#xD;
      Specific Aim #2: To determine if there is a difference in the rates of intraoperative bladder&#xD;
      injuries between the study groups. This will be determined by comparing the rates of&#xD;
      intraoperative bladder injuries between the two study groups.&#xD;
&#xD;
      Specific Aim #3: To determine the rate of urinary tract complications after insertion of the&#xD;
      intra operative urinary catheter for the control group. This will be accomplished by&#xD;
      analyzing the rates of urinary tract injury, infections and bladder injuries due to&#xD;
      intraoperative catheter placement.&#xD;
&#xD;
      Specific Aim #4: To determine the rate of urinary tract complications after insertion of a&#xD;
      urinary catheter for patients who develop PUR. This will be accomplished by analyzing the&#xD;
      rates of urinary tract injury, or infections and bladder injuries due to catheter placement&#xD;
      after patients develop PUR.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 7, 2019</start_date>
  <completion_date type="Actual">April 15, 2021</completion_date>
  <primary_completion_date type="Actual">March 24, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Post Operative Urinary Retention</measure>
    <time_frame>From the day of surgery until postoperative day 30</time_frame>
    <description>The rate of postoperative urinary retention requiring insertion of a urinary catheter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Intraoperative Bladder Injuries</measure>
    <time_frame>Measured from Beginning of Anesthesia to the End of Anesthesia and up to 4 hours Post Operatively</time_frame>
    <description>This will be determined by comparing the rates of intraoperative bladder injuries between the two study groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Have Complications From Intra-operative Urinary Catheter</measure>
    <time_frame>From the day of surgery until postoperative day 30</time_frame>
    <description>This will be accomplished by analyzing the rates of urinary tract injury, infections and bladder injuries due to intraoperative catheter placement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Complications Urinary Catheter Who Develop Retention</measure>
    <time_frame>From the day of surgery until postoperative day 30</time_frame>
    <description>This will be accomplished by analyzing the rates of urinary tract injury, or infections and bladder injuries due to catheter placement after patients develop post operative urinary retention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">491</enrollment>
  <condition>Inguinal Hernia</condition>
  <arm_group>
    <arm_group_label>Intraoperative urinary catheter</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>After induction of general anesthesia, a standard catheterization kit available at the institution where the surgery is being performed will be used to place the urinary catheter using standard sterile technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intraoperative urinary catheter</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intraoperative urinary catheter will be used during the case</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Urinary Catheter</intervention_name>
    <description>An intraoperative urinary catheter will be inserted which will be taken out at the end of the case</description>
    <arm_group_label>Intraoperative urinary catheter</arm_group_label>
    <other_name>Foley</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Unilateral or bilateral inguinal hernia&#xD;
&#xD;
          -  Scheduled for elective inguinal hernia repair&#xD;
&#xD;
          -  Eligible to tolerate general anesthesia&#xD;
&#xD;
          -  Eligible to undergo minimally invasive inguinal hernia repair&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with benign prostate hyperplasia (BPH)&#xD;
&#xD;
          -  Younger than 18 years old&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
&#xD;
          -  Emergent inguinal hernia repairs ( acute incarceration or strangulation)&#xD;
&#xD;
          -  Unable to tolerate general anesthesia&#xD;
&#xD;
          -  Not eligible for minimally invasive inguinal hernia repair&#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_official>
    <last_name>Michael Rosen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Comprehensive Hernia Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Koch CA, Grinberg GG, Farley DR. Incidence and risk factors for urinary retention after endoscopic hernia repair. Am J Surg. 2006 Mar;191(3):381-5. doi: 10.1016/j.amjsurg.2005.10.042.</citation>
    <PMID>16490551</PMID>
  </reference>
  <reference>
    <citation>Jensen P, Mikkelsen T, Kehlet H. Postherniorrhaphy urinary retention--effect of local, regional, and general anesthesia: a review. Reg Anesth Pain Med. 2002 Nov-Dec;27(6):612-7. doi: 10.1053/rapm.2002.37122.</citation>
    <PMID>12430114</PMID>
  </reference>
  <reference>
    <citation>Blair AB, Dwarakanath A, Mehta A, Liang H, Hui X, Wyman C, Ouanes JPP, Nguyen HT. Postoperative urinary retention after inguinal hernia repair: a single institution experience. Hernia. 2017 Dec;21(6):895-900. doi: 10.1007/s10029-017-1661-4. Epub 2017 Sep 4.</citation>
    <PMID>28871414</PMID>
  </reference>
  <reference>
    <citation>Patel JA, Kaufman AS, Howard RS, Rodriguez CJ, Jessie EM. Risk factors for urinary retention after laparoscopic inguinal hernia repairs. Surg Endosc. 2015 Nov;29(11):3140-5. doi: 10.1007/s00464-014-4039-z. Epub 2015 Jan 1.</citation>
    <PMID>25552230</PMID>
  </reference>
  <reference>
    <citation>Sivasankaran MV, Pham T, Divino CM. Incidence and risk factors for urinary retention following laparoscopic inguinal hernia repair. Am J Surg. 2014 Feb;207(2):288-92. doi: 10.1016/j.amjsurg.2013.06.005. Epub 2013 Nov 5.</citation>
    <PMID>24200291</PMID>
  </reference>
  <reference>
    <citation>Muysoms FE, Vanlander A, Ceulemans R, Kyle-Leinhase I, Michiels M, Jacobs I, Pletinckx P, Berrevoet F. A prospective, multicenter, observational study on quality of life after laparoscopic inguinal hernia repair with ProGrip laparoscopic, self-fixating mesh according to the European Registry for Abdominal Wall Hernias Quality of Life Instrument. Surgery. 2016 Nov;160(5):1344-1357. doi: 10.1016/j.surg.2016.04.026. Epub 2016 Jun 14.</citation>
    <PMID>27316825</PMID>
  </reference>
  <reference>
    <citation>Arnold MR, Coakley KM, Fromke EJ, Groene SA, Prasad T, Colavita PD, Augenstein VA, Kercher KW, Heniford BT. Long-term assessment of surgical and quality-of-life outcomes between lightweight and standard (heavyweight) three-dimensional contoured mesh in laparoscopic inguinal hernia repair. Surgery. 2019 Apr;165(4):820-824. doi: 10.1016/j.surg.2018.10.016. Epub 2018 Nov 16.</citation>
    <PMID>30449696</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <results_first_submitted>March 7, 2022</results_first_submitted>
  <results_first_submitted_qc>April 6, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 3, 2022</results_first_posted>
  <last_update_submitted>April 6, 2022</last_update_submitted>
  <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Michael Rosen</investigator_full_name>
    <investigator_title>Director of the Comprehensive Hernia Center</investigator_title>
  </responsible_party>
  <keyword>Urinary catheter</keyword>
  <keyword>Urinary retention</keyword>
  <keyword>Laparoscopic inguinal hernia repair</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Retention</mesh_term>
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Inguinal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be shared, rather the results of the aggregate groups of patients will be shared</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 21, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT03835351/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 25, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT03835351/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intraoperative Urinary Catheter</title>
          <description>After induction of general anesthesia, a standard catheterization kit available at the institution where the surgery is being performed will be used to place the urinary catheter using standard sterile technique.&#xD;
Urinary Catheter: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case</description>
        </group>
        <group group_id="P2">
          <title>No Intraoperative Urinary Catheter</title>
          <description>No intraoperative urinary catheter will be used during the case</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="241"/>
                <participants group_id="P2" count="250"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="241"/>
                <participants group_id="P2" count="250"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intraoperative Urinary Catheter</title>
          <description>After induction of general anesthesia, a standard catheterization kit available at the institution where the surgery is being performed will be used to place the urinary catheter using standard sterile technique.&#xD;
Urinary Catheter: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case</description>
        </group>
        <group group_id="B2">
          <title>No Intraoperative Urinary Catheter</title>
          <description>No intraoperative urinary catheter will be used during the case</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="241"/>
            <count group_id="B2" value="250"/>
            <count group_id="B3" value="491"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61" lower_limit="52" upper_limit="68"/>
                    <measurement group_id="B2" value="62" lower_limit="49" upper_limit="69"/>
                    <measurement group_id="B3" value="61" lower_limit="51" upper_limit="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="232"/>
                    <measurement group_id="B2" value="233"/>
                    <measurement group_id="B3" value="465"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian or Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black, not of Hispanic Origin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Middle Eastern</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White, not of Hispanic Origin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="209"/>
                    <measurement group_id="B2" value="204"/>
                    <measurement group_id="B3" value="413"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="241"/>
                    <measurement group_id="B2" value="250"/>
                    <measurement group_id="B3" value="491"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Post Operative Urinary Retention</title>
        <description>The rate of postoperative urinary retention requiring insertion of a urinary catheter</description>
        <time_frame>From the day of surgery until postoperative day 30</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intraoperative Urinary Catheter</title>
            <description>After induction of general anesthesia, a standard catheterization kit available at the institution where the surgery is being performed will be used to place the urinary catheter using standard sterile technique.&#xD;
Urinary Catheter: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case</description>
          </group>
          <group group_id="O2">
            <title>No Intraoperative Urinary Catheter</title>
            <description>No intraoperative urinary catheter will be used during the case</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Post Operative Urinary Retention</title>
          <description>The rate of postoperative urinary retention requiring insertion of a urinary catheter</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Intraoperative Bladder Injuries</title>
        <description>This will be determined by comparing the rates of intraoperative bladder injuries between the two study groups</description>
        <time_frame>Measured from Beginning of Anesthesia to the End of Anesthesia and up to 4 hours Post Operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intraoperative Urinary Catheter</title>
            <description>After induction of general anesthesia, a standard catheterization kit available at the institution where the surgery is being performed will be used to place the urinary catheter using standard sterile technique.&#xD;
Urinary Catheter: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case</description>
          </group>
          <group group_id="O2">
            <title>No Intraoperative Urinary Catheter</title>
            <description>No intraoperative urinary catheter will be used during the case</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Intraoperative Bladder Injuries</title>
          <description>This will be determined by comparing the rates of intraoperative bladder injuries between the two study groups</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Have Complications From Intra-operative Urinary Catheter</title>
        <description>This will be accomplished by analyzing the rates of urinary tract injury, infections and bladder injuries due to intraoperative catheter placement.</description>
        <time_frame>From the day of surgery until postoperative day 30</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intraoperative Urinary Catheter</title>
            <description>After induction of general anesthesia, a standard catheterization kit available at the institution where the surgery is being performed will be used to place the urinary catheter using standard sterile technique.&#xD;
Urinary Catheter: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case</description>
          </group>
          <group group_id="O2">
            <title>No Intraoperative Urinary Catheter</title>
            <description>No intraoperative urinary catheter will be used during the case</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Have Complications From Intra-operative Urinary Catheter</title>
          <description>This will be accomplished by analyzing the rates of urinary tract injury, infections and bladder injuries due to intraoperative catheter placement.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Intraop Complication Urethral Trauma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intraop Complication, other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Complications Urinary Catheter Who Develop Retention</title>
        <description>This will be accomplished by analyzing the rates of urinary tract injury, or infections and bladder injuries due to catheter placement after patients develop post operative urinary retention.</description>
        <time_frame>From the day of surgery until postoperative day 30</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intraoperative Urinary Catheter</title>
            <description>After induction of general anesthesia, a standard catheterization kit available at the institution where the surgery is being performed will be used to place the urinary catheter using standard sterile technique.&#xD;
Urinary Catheter: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case</description>
          </group>
          <group group_id="O2">
            <title>No Intraoperative Urinary Catheter</title>
            <description>No intraoperative urinary catheter will be used during the case</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Complications Urinary Catheter Who Develop Retention</title>
          <description>This will be accomplished by analyzing the rates of urinary tract injury, or infections and bladder injuries due to catheter placement after patients develop post operative urinary retention.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Urinary Tract Injury</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bladder Injuries</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Infection</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="219"/>
                    <measurement group_id="O2" value="222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days following surgery</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intraoperative Urinary Catheter</title>
          <description>After induction of general anesthesia, a standard catheterization kit available at the institution where the surgery is being performed will be used to place the urinary catheter using standard sterile technique.&#xD;
Urinary Catheter: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case</description>
        </group>
        <group group_id="E2">
          <title>No Intraoperative Urinary Catheter</title>
          <description>No intraoperative urinary catheter will be used during the case</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urethra Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia Requiring Transfusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Bowel Obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Michael Rosen</name_or_title>
      <organization>Cleveland Clinic Foundation</organization>
      <phone>12164453441</phone>
      <email>rosenm@ccf.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03835351
org study id: 19-070
nct id: NCT03835351
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This will be a randomized controlled study which will compare the rate of post-operative
      urinary retention after laparoscopic inguinal hernia repair between patients who receive an
      intra-operative urinary catheter and those who do not. The primary aim of the study is to
      determine if the use of intra-operative urinary catheter reduces the incidence of
      post-operative urinary retention after laparoscopic inguinal hernia repair. Specific patient
      inclusion criteria include all patients aged 18 years or older presenting for an elective
      unilateral or bilateral inguinal hernia repair, who are able to tolerate general anesthesia
      and are considered eligible to have a hernia repair through a laparoscopic approach.
An inguinal hernia repair is a common outpatient procedure with a low rate of morbidity. One
      well-recognized complication of this operation is post-operative urinary retention (PUR),
      which is a failure of spontaneous voiding requiring insertion of a urinary catheter. The
      reported incidence of PUR ranges between 0.4 and 3% of open tension-free repairs. For
      laparoscopic inguinal hernia repairs that range is between 1 and 22. Since no randomized
      controlled trials have evaluated PUR as the primary outcome exist in literature, there is no
      consensus on whether catheter use aids in minimizing post-operative urinary retention.
      Routine use of intraoperative catheterization increases the risk of urethral trauma,
      catheter-associated infections and bladder damage leading to increased cost of care and
      potential patient morbidity. On the other hand, PUR is associated with additional procedures,
      such as catheterization, which may delay hospital discharge or increase the length of stay
      and cause patient discomfort. This work aims to study the effect of intraoperative catheters
      on PUR and whether the aforementioned risks associated with this procedure are justified.

      We hypothesize that the use of intra-operative urinary catheter reduces the incidence of
      postoperative urinary retention after laparoscopic inguinal hernia repair, thus justifying
      the potential complications associated with intra-operative catheter insertion.

      All patients will be asked to void in the pre-operative area prior to going into the
      operating room. Patients will be operated in the supine, and slight Trendelenburg position
      (15º degrees), with arms tucked along the body. The procedure will be performed under general
      anesthesia. After induction of anesthesia, randomization will occur. It will be performed
      according to a computer-generated block randomization scheme. The randomization will be
      stratified for unilateral or bilateral hernias. Antibiotic prophylaxis will be performed
      according to institutional protocol. Pharmacological prophylaxis of venous thromboembolic
      events is usually not necessary for general laparoscopic inguinal hernia repair. Although, if
      deemed necessary, this will be performed per Surgical Care Improvement Project (SCIP)
      protocol and will not be considered a protocol deviation. Skin preparation and hair removal
      will be performed per SCIP protocol. All necessary materials, including the urine
      catheterization kit, will be available in the operative room before the start of the
      procedure.

      The Americas Hernia Society Quality Collaborative (AHSQC) registry will serve as the main
      platform for data collection. Registry-based trials use data available in a preexisting
      database to increase the efficiency of performing RCTs, decreasing the high cost and
      logistical challenges associated with operationalizing this type of research. Post-operative
      urinary retention will be defined as post-operative failure to void requiring straight
      catheterization, placement of an indwelling catheter or return to the emergency department
      due to failure to void after discharge from the hospital. Bladder scanning, its timing and
      specific criteria for placement of urinary catheter will be determined by the standard
      policies of each institution where the surgery was performed and the surgeon.

      Specific Aim #1: To determine if the use of intra-operative urinary catheter reduces the
      incidence of postoperative urinary retention after laparoscopic inguinal hernia repair. This
      will be assessed by comparing the PUR rates between the two study groups.

      Specific Aim #2: To determine if there is a difference in the rates of intraoperative bladder
      injuries between the study groups. This will be determined by comparing the rates of
      intraoperative bladder injuries between the two study groups.

      Specific Aim #3: To determine the rate of urinary tract complications after insertion of the
      intra operative urinary catheter for the control group. This will be accomplished by
      analyzing the rates of urinary tract injury, infections and bladder injuries due to
      intraoperative catheter placement.

      Specific Aim #4: To determine the rate of urinary tract complications after insertion of a
      urinary catheter for patients who develop PUR. This will be accomplished by analyzing the
      rates of urinary tract injury, or infections and bladder injuries due to catheter placement
      after patients develop PUR.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Number of Participants With Post Operative Urinary Retention
time frame: From the day of surgery until postoperative day 30
description: The rate of postoperative urinary retention requiring insertion of a urinary catheter
measure: Number of Participants With Intraoperative Bladder Injuries
time frame: Measured from Beginning of Anesthesia to the End of Anesthesia and up to 4 hours Post Operatively
description: This will be determined by comparing the rates of intraoperative bladder injuries between the two study groups
measure: Number of Participants Who Have Complications From Intra-operative Urinary Catheter
time frame: From the day of surgery until postoperative day 30
description: This will be accomplished by analyzing the rates of urinary tract injury, infections and bladder injuries due to intraoperative catheter placement.
measure: Number of Participants With Complications Urinary Catheter Who Develop Retention
time frame: From the day of surgery until postoperative day 30
description: This will be accomplished by analyzing the rates of urinary tract injury, or infections and bladder injuries due to catheter placement after patients develop post operative urinary retention.
arm group label: Intraoperative urinary catheter
arm group type: Other
description: After induction of general anesthesia, a standard catheterization kit available at the institution where the surgery is being performed will be used to place the urinary catheter using standard sterile technique.
arm group label: No intraoperative urinary catheter
arm group type: No Intervention
description: No intraoperative urinary catheter will be used during the case
intervention type: Device
intervention name: Urinary Catheter
description: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case
arm group label: Intraoperative urinary catheter
other name: Foley
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Rosen, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
citation: Koch CA, Grinberg GG, Farley DR. Incidence and risk factors for urinary retention after endoscopic hernia repair. Am J Surg. 2006 Mar;191(3):381-5. doi: 10.1016/j.amjsurg.2005.10.042.
PMID: 16490551
citation: Jensen P, Mikkelsen T, Kehlet H. Postherniorrhaphy urinary retention--effect of local, regional, and general anesthesia: a review. Reg Anesth Pain Med. 2002 Nov-Dec;27(6):612-7. doi: 10.1053/rapm.2002.37122.
PMID: 12430114
citation: Blair AB, Dwarakanath A, Mehta A, Liang H, Hui X, Wyman C, Ouanes JPP, Nguyen HT. Postoperative urinary retention after inguinal hernia repair: a single institution experience. Hernia. 2017 Dec;21(6):895-900. doi: 10.1007/s10029-017-1661-4. Epub 2017 Sep 4.
PMID: 28871414
citation: Patel JA, Kaufman AS, Howard RS, Rodriguez CJ, Jessie EM. Risk factors for urinary retention after laparoscopic inguinal hernia repairs. Surg Endosc. 2015 Nov;29(11):3140-5. doi: 10.1007/s00464-014-4039-z. Epub 2015 Jan 1.
PMID: 25552230
citation: Sivasankaran MV, Pham T, Divino CM. Incidence and risk factors for urinary retention following laparoscopic inguinal hernia repair. Am J Surg. 2014 Feb;207(2):288-92. doi: 10.1016/j.amjsurg.2013.06.005. Epub 2013 Nov 5.
PMID: 24200291
citation: Muysoms FE, Vanlander A, Ceulemans R, Kyle-Leinhase I, Michiels M, Jacobs I, Pletinckx P, Berrevoet F. A prospective, multicenter, observational study on quality of life after laparoscopic inguinal hernia repair with ProGrip laparoscopic, self-fixating mesh according to the European Registry for Abdominal Wall Hernias Quality of Life Instrument. Surgery. 2016 Nov;160(5):1344-1357. doi: 10.1016/j.surg.2016.04.026. Epub 2016 Jun 14.
PMID: 27316825
citation: Arnold MR, Coakley KM, Fromke EJ, Groene SA, Prasad T, Colavita PD, Augenstein VA, Kercher KW, Heniford BT. Long-term assessment of surgical and quality-of-life outcomes between lightweight and standard (heavyweight) three-dimensional contoured mesh in laparoscopic inguinal hernia repair. Surgery. 2019 Apr;165(4):820-824. doi: 10.1016/j.surg.2018.10.016. Epub 2018 Nov 16.
PMID: 30449696
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Michael Rosen
investigator title: Director of the Comprehensive Hernia Center
mesh term: Urinary Retention
mesh term: Hernia
mesh term: Hernia, Inguinal
sharing ipd: No
ipd description: Individual participant data will not be shared, rather the results of the aggregate groups of patients will be shared
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 