<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/NCT03750461</url>
  </required_header>
  <id_info>
    <org_study_id>D18101</org_study_id>
    <nct_id>NCT03750461</nct_id>
  </id_info>
  <brief_title>Stoma Closure and Reinforcement Trial</brief_title>
  <acronym>SCAR</acronym>
  <official_title>Stoma Closure and Reinforcement (SCAR) Trial - A Single Center Pilot Study of the Safety of a Mesh Reinforcement of Ileostomy Closure to Prevent Hernia Formation in Left Sided Colon and Rectal Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hitchcock Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hernia formation at sites of ostomy closure is a common complication. The investigator&#xD;
      believes that using evidence based hernia repair techniques as a preventive measure during&#xD;
      closure of ostomies will reduce the incidence of hernia formation. In this trial, the&#xD;
      investigator will pilot a novel technique of large pore monofilament polypropylene mesh&#xD;
      reinforcement of the abdominal wall defects that remain after closure of an ileostomy to&#xD;
      evaluate for safety and begin to evaluate the effectiveness compared to standard techniques.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">February 1, 2023</completion_date>
  <primary_completion_date type="Actual">January 30, 2021</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>
    <intervention_model_description>Modified Simon-Two Step. An initial cohort of 5 patients will be enrolled and treated sequentially with 30 day follow-up. If stopping criteria are not met, the cohort will be expanded to an additional 15 patients followed concurrently for the duration of the study period</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Wound Occurrences</measure>
    <time_frame>30 days</time_frame>
    <description>Incidence of wound occurrences (defined as superficial surgical site infection [s-SSI], deep surgical site infection [d-SSI], organ space surgical site infection [O-SSI], dehiscence, and seroma formation) at 30 days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls</measure>
    <time_frame>30 days</time_frame>
    <description>The incidence of wound occurrences (defined as superficial surgical site infection [s-SSI], deep surgical site infection [d-SSI], organ space surgical site infection [O-SSI], dehiscence, and seroma formation) at 30days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be compared to historical controls.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preliminary Efficacy Based on Number of Participants With Hernia Formation</measure>
    <time_frame>30 days, and then 6 months post procedure</time_frame>
    <description>Evaluation of the incidence of hernia formation at the ileostomy site on a prospective basis at 30 days and 6 month intervals thereafter until two years from the date of ileostomy closure using computed tomography and clinical examination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bowel Function After Mesh Implantation</measure>
    <time_frame>2 years</time_frame>
    <description>Patient will be evaluated with regards to their bowel function outcomes utilizing the Colorectal Function Outcome (COREFO) instrument to evaluate bowel function. Score range is 0-100, Higher score indicates worse bowel function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life After Mesh Implantation</measure>
    <time_frame>2 years</time_frame>
    <description>Patient will be evaluated with regards to their quality of life outcomes utilizing the Promis SF 2.0 8a Ability to Participate in Social Roles and Activities instrument. Score range is 0-40, Higher scores represents better quality of life</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Colon Cancer</condition>
  <condition>Rectal Cancer</condition>
  <condition>Ileostomy - Stoma</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mesh Implantation</intervention_name>
    <description>Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 18years&#xD;
&#xD;
          2. Patient is undergoing closure of loop ileostomy&#xD;
&#xD;
          3. Patient has a diagnosis of left sided colon or rectal cancer treated with resection&#xD;
             and diverting loop ileostomy&#xD;
&#xD;
          4. Patient has been evaluated by a qualified surgeon and found to be a suitable candidate&#xD;
             for surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pre-existing systemic infection at the time of ileostomy takedown&#xD;
&#xD;
          2. Cirrhosis, chronic renal failure requiring dialysis, or collagen disorder&#xD;
&#xD;
          3. On current immunosuppression (anti-tumor necrosis factor (TNF) agents, chemotherapy,&#xD;
             or prednisone &gt;10mg/day)&#xD;
&#xD;
          4. Previous abdominal hernia repair with mesh placement&#xD;
&#xD;
          5. Concurrent procedures in addition to closure of diverting loop ileostomy&#xD;
&#xD;
          6. Ileostomy closure not completed through the previous stoma site (i.e. those requiring&#xD;
             exploratory laparotomy for closure)&#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>Matthew Z Wilson, MD, Msc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth-Hitchcock Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <results_first_submitted>January 13, 2022</results_first_submitted>
  <results_first_submitted_qc>February 15, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 10, 2022</results_first_posted>
  <last_update_submitted>February 20, 2023</last_update_submitted>
  <last_update_submitted_qc>February 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>Matthew Z. Wilson</investigator_full_name>
    <investigator_title>Assistant Professor of Surgery</investigator_title>
  </responsible_party>
  <keyword>ileostomy</keyword>
  <keyword>hernia</keyword>
  <keyword>rectal cancer</keyword>
  <keyword>colon cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>February 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03750461/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Adult patients (Interventional group)with left sided CRC who underwent proximal diversion with a LI as part of their surgical therapy were recruited from the clinical practice of the Division of Colon and Rectal Surgery at DHMC between January 2019 and November 2020.&#xD;
Historical Controls were patients diagnosed with colorectal cancer and who underwent stoma reversals from January 1, 2011, to December 31, 2018 from the clinical practice of the Division of Colon and Rectal Surgery at DHMC.</recruitment_details>
      <pre_assignment_details>24 Adult patients with left-sided colon and rectal cancer treated with resection and diverting loop ileostomy were eligible to participate. 4 participants declined participation and were not enrolled.&#xD;
Historical Controls. Data for only those who met the inclusion criteria was collected. Data collected was only relevant to the Primary endpoint, and additional follow-up date was no collected beyond the data needed for analysis for the primary outcome measure.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall&#xD;
Mesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation</description>
        </group>
        <group group_id="P2">
          <title>Historical Controls</title>
          <description>Patients diagnosed with colon or rectal cancer, identified by relevant International Classification of Disease 9/10 codes, and who underwent a stoma reversal procedure, identified by pertinent current procedural terminology (CPT) codes.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="92"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Primary Endpoint</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="92">Considered study completion for the Historical Controls.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Secondary Endpoint</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="0">Not applicable for the historical controls.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="0">Not applicable for the historical controls; no follow-up data was collected.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="92"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall&#xD;
Mesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation</description>
        </group>
        <group group_id="B2">
          <title>Historical Controls</title>
          <description>Patients diagnosed with colon or rectal cancer, identified by relevant International Classification of Disease 9/10 codes, and who underwent a stoma reversal procedure, identified by pertinent current procedural terminology (CPT) codes.</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="20"/>
            <count group_id="B2" value="92"/>
            <count group_id="B3" value="112"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62" lower_limit="47" upper_limit="85"/>
                    <measurement group_id="B2" value="58" lower_limit="27" upper_limit="92"/>
                    <measurement group_id="B3" value="60" lower_limit="27" upper_limit="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Mean</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="120"/>
                  </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="8"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="91"/>
                    <measurement group_id="B3" value="110"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="20"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.19" spread="7.9"/>
                    <measurement group_id="B2" value="27.3" spread="4.95"/>
                    <measurement group_id="B3" value="28.245" spread="6.425"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Wound Occurrences</title>
        <description>Incidence of wound occurrences (defined as superficial surgical site infection [s-SSI], deep surgical site infection [d-SSI], organ space surgical site infection [O-SSI], dehiscence, and seroma formation) at 30 days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be assessed.</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall&#xD;
Mesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Wound Occurrences</title>
          <description>Incidence of wound occurrences (defined as superficial surgical site infection [s-SSI], deep surgical site infection [d-SSI], organ space surgical site infection [O-SSI], dehiscence, and seroma formation) at 30 days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be assessed.</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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls</title>
        <description>The incidence of wound occurrences (defined as superficial surgical site infection [s-SSI], deep surgical site infection [d-SSI], organ space surgical site infection [O-SSI], dehiscence, and seroma formation) at 30days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be compared to historical controls.</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall&#xD;
Mesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation</description>
          </group>
          <group group_id="O2">
            <title>Historical Controls</title>
            <description>Patients diagnosed with colon or rectal cancer, identified by relevant International Classification of Disease 9/10 codes, and who underwent a stoma reversal procedure, identified by pertinent current procedural terminology (CPT) codes.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls</title>
          <description>The incidence of wound occurrences (defined as superficial surgical site infection [s-SSI], deep surgical site infection [d-SSI], organ space surgical site infection [O-SSI], dehiscence, and seroma formation) at 30days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be compared to historical controls.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>superficial wound infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>deep wound infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>organ/space infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>wound disruption</title>
              <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>Preliminary Efficacy Based on Number of Participants With Hernia Formation</title>
        <description>Evaluation of the incidence of hernia formation at the ileostomy site on a prospective basis at 30 days and 6 month intervals thereafter until two years from the date of ileostomy closure using computed tomography and clinical examination.</description>
        <time_frame>30 days, and then 6 months post procedure</time_frame>
        <population>One participant was lost to follow-up due to declining cancer surveillance.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall&#xD;
Mesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation</description>
          </group>
        </group_list>
        <measure>
          <title>Preliminary Efficacy Based on Number of Participants With Hernia Formation</title>
          <description>Evaluation of the incidence of hernia formation at the ileostomy site on a prospective basis at 30 days and 6 month intervals thereafter until two years from the date of ileostomy closure using computed tomography and clinical examination.</description>
          <population>One participant was lost to follow-up due to declining cancer surveillance.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30 Days post procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months post procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bowel Function After Mesh Implantation</title>
        <description>Patient will be evaluated with regards to their bowel function outcomes utilizing the Colorectal Function Outcome (COREFO) instrument to evaluate bowel function. Score range is 0-100, Higher score indicates worse bowel function.</description>
        <time_frame>2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall&#xD;
Mesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation</description>
          </group>
        </group_list>
        <measure>
          <title>Bowel Function After Mesh Implantation</title>
          <description>Patient will be evaluated with regards to their bowel function outcomes utilizing the Colorectal Function Outcome (COREFO) instrument to evaluate bowel function. Score range is 0-100, Higher score indicates worse bowel function.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" lower_limit="10" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life After Mesh Implantation</title>
        <description>Patient will be evaluated with regards to their quality of life outcomes utilizing the Promis SF 2.0 8a Ability to Participate in Social Roles and Activities instrument. Score range is 0-40, Higher scores represents better quality of life</description>
        <time_frame>2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall&#xD;
Mesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life After Mesh Implantation</title>
          <description>Patient will be evaluated with regards to their quality of life outcomes utilizing the Promis SF 2.0 8a Ability to Participate in Social Roles and Activities instrument. Score range is 0-40, Higher scores represents better quality of life</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33" lower_limit="15" upper_limit="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From date of surgery to follow-up at approximately 2 years.</time_frame>
      <desc>Interventional arm: Adverse events were collected for surgical site occurrences (surgical site infection, mesh infection, delayed wound healing), fascial dehiscence, seroma, hematoma, cellulitis or enterocutaneous fistula, or return to the operating room for mesh removal.&#xD;
Historical Controls: Only adverse events relating to wound or organ/space infection and wound disruption were collected.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall&#xD;
Mesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation</description>
        </group>
        <group group_id="E2">
          <title>Historical Controls</title>
          <description>Patients diagnosed with colon or rectal cancer, identified by relevant International Classification of Disease 9/10 codes, and who underwent a stoma reversal procedure, identified by pertinent current procedural terminology (CPT) codes.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </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="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ogilvie's syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>superficial wound infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>organ/space infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="92"/>
              </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>Matthew Z. Wilson, MD MSc FACS FASCRS</name_or_title>
      <organization>Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH Geisel School of Medicine, Hanover, NH</organization>
      <phone>(603) 650-8113</phone>
      <email>Matthew.Z.Wilson@hitchcock.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/NCT03750461
org study id: D18101
nct id: NCT03750461
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Hernia formation at sites of ostomy closure is a common complication. The investigator
      believes that using evidence based hernia repair techniques as a preventive measure during
      closure of ostomies will reduce the incidence of hernia formation. In this trial, the
      investigator will pilot a novel technique of large pore monofilament polypropylene mesh
      reinforcement of the abdominal wall defects that remain after closure of an ileostomy to
      evaluate for safety and begin to evaluate the effectiveness compared to standard techniques.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Modified Simon-Two Step. An initial cohort of 5 patients will be enrolled and treated sequentially with 30 day follow-up. If stopping criteria are not met, the cohort will be expanded to an additional 15 patients followed concurrently for the duration of the study period
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Participants With Wound Occurrences
time frame: 30 days
description: Incidence of wound occurrences (defined as superficial surgical site infection [s-SSI], deep surgical site infection [d-SSI], organ space surgical site infection [O-SSI], dehiscence, and seroma formation) at 30 days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be assessed.
measure: Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls
time frame: 30 days
description: The incidence of wound occurrences (defined as superficial surgical site infection [s-SSI], deep surgical site infection [d-SSI], organ space surgical site infection [O-SSI], dehiscence, and seroma formation) at 30days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be compared to historical controls.
measure: Preliminary Efficacy Based on Number of Participants With Hernia Formation
time frame: 30 days, and then 6 months post procedure
description: Evaluation of the incidence of hernia formation at the ileostomy site on a prospective basis at 30 days and 6 month intervals thereafter until two years from the date of ileostomy closure using computed tomography and clinical examination.
measure: Bowel Function After Mesh Implantation
time frame: 2 years
description: Patient will be evaluated with regards to their bowel function outcomes utilizing the Colorectal Function Outcome (COREFO) instrument to evaluate bowel function. Score range is 0-100, Higher score indicates worse bowel function.
measure: Quality of Life After Mesh Implantation
time frame: 2 years
description: Patient will be evaluated with regards to their quality of life outcomes utilizing the Promis SF 2.0 8a Ability to Participate in Social Roles and Activities instrument. Score range is 0-40, Higher scores represents better quality of life
arm group label: Intervention
arm group type: Experimental
description: Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall
intervention type: Device
intervention name: Mesh Implantation
description: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew Z Wilson, MD, Msc
role: Principal Investigator
affiliation: Dartmouth-Hitchcock Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Matthew Z. Wilson
investigator title: Assistant Professor of Surgery
mesh term: Rectal Neoplasms
mesh term: Colonic Neoplasms
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 