<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/NCT03008707</url>
  </required_header>
  <id_info>
    <org_study_id>n° 890</org_study_id>
    <nct_id>NCT03008707</nct_id>
  </id_info>
  <brief_title>Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study (STELLA Study)</brief_title>
  <acronym>STELLA</acronym>
  <official_title>Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliero, Universitaria Pisana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ospedale San Jacopo, Pistoia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>S. Andrea Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maggiore Bellaria Hospital, Bologna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IRCCS Azienda Ospedaliero-Universitaria di Bologna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>A.O. Ospedale Papa Giovanni XXIII</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospitales Universitarios Virgen del Rocío</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>George Papanicolaou Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Azienda Ospedaliero, Universitaria Pisana</source>
  <brief_summary>
    <textblock>
      Laparoscopic peritoneal lavage (LPL) has recently been emerging as an effective alternative&#xD;
      to laparoscopic sigmoidectomy (LS) in patients with complicated acute diverticulitis (CAD)&#xD;
      (Modified Hinchey's classification grade II non-responder to conservative therapy and grade&#xD;
      III). Aim of the study is to evaluate which surgical strategy, between LPL and LS, could give&#xD;
      better results in patients with CAD&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the literature, there is no consensus about the role of the laparoscopic peritoneal lavage&#xD;
      in the management of complicated acute diverticulitis. Recently, three important prospective&#xD;
      randomized-control studies (SCANDIV, LOLA, DILALA) have reported contradicting conclusions,&#xD;
      as two of them (SCANDIV and LOLA) state that LPL is not superior to sigmoidectomy for the&#xD;
      high reoperation rate and morbidity, while DILALA confirms that LPL is feasible and safe in&#xD;
      the short-term. To our knowledge, no international guidelines promote the use of LPL in&#xD;
      complicated acute diverticulitis. We believe this technique could be safely used in a&#xD;
      selected cohort of patients and, in some circumstances, could represent a &quot;bridge&quot; to a&#xD;
      possible planned resection. The aim of the study is to collect and analyze the multicentric&#xD;
      data of the LPL and LS and give a substantial contribution to the scientific community about&#xD;
      this very debated topic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Short-term Morbidity</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Short-term Mortality</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Optimal Sepsis Control</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative Re-interventions Rate</measure>
    <time_frame>15 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Postoperative Time</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Length of Postoperative Hospital Stay</measure>
    <time_frame>30 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrent Colonic Diverticulitis Rate</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incisional Hernia Rate</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">66</enrollment>
  <condition>Acute Diverticulitis</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Patients who undergo Laparoscopic Peritoneal Lavage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Patients who have a laparoscopically approached sigmoidectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic Peritoneal Lavage</intervention_name>
    <description>LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with complicated acute diverticulitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute abdominal pain,&#xD;
&#xD;
          -  Signs of localized or diffuse peritonitis&#xD;
&#xD;
          -  Signs of suspected perforated diverticulitis (diagnostic imaging)&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Septic shock&#xD;
&#xD;
          -  Immunodepression&#xD;
&#xD;
          -  Previous multiple abdominal surgical operations&#xD;
&#xD;
          -  Modified Hinchey's grade IV&#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>Dario Tartaglia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero, Universitaria Pisana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azienda Ospedaliero, Universitaria Pisana</name>
      <address>
        <city>Pisa</city>
        <state>Tuscany</state>
        <zip>56021</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <results_first_submitted>June 7, 2019</results_first_submitted>
  <results_first_submitted_qc>August 26, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 25, 2019</results_first_posted>
  <last_update_submitted>August 26, 2019</last_update_submitted>
  <last_update_submitted_qc>August 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliero, Universitaria Pisana</investigator_affiliation>
    <investigator_full_name>Dario Tartaglia</investigator_full_name>
    <investigator_title>MD, PhD Candidate</investigator_title>
  </responsible_party>
  <keyword>Laparoscopic peritoneal lavage</keyword>
  <keyword>laparoscopic sigmoidectomy</keyword>
  <keyword>complicated acute diverticulitis</keyword>
  <keyword>D004238</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diverticulitis</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03008707/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03008707/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Laparoscopic Peritoneal Lavage</title>
          <description>Patients who undergo Laparoscopic Peritoneal Lavage&#xD;
Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites</description>
        </group>
        <group group_id="P2">
          <title>Laparoscopically Approached Sigmoidectomy</title>
          <description>Patients who have a laparoscopically approached sigmoidectomy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="38"/>
              </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>Laparoscopic Peritoneal Lavage</title>
          <description>Patients who undergo Laparoscopic Peritoneal Lavage&#xD;
Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites</description>
        </group>
        <group group_id="B2">
          <title>Laparoscopically Approached Sigmoidectomy</title>
          <description>Patients who have a laparoscopically approached sigmoidectomy</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="28"/>
            <count group_id="B2" value="38"/>
            <count group_id="B3" value="66"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.25" spread="13.21"/>
                    <measurement group_id="B2" value="55.68" spread="10.81"/>
                    <measurement group_id="B3" value="57.19" spread="11.92"/>
                  </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="15"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="39"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="66"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Short-term Morbidity</title>
        <time_frame>30 days</time_frame>
        <population>In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection</population>
        <group_list>
          <group group_id="O1">
            <title>Laparoscopic Peritoneal Lavage</title>
            <description>Patients who undergo Laparoscopic Peritoneal Lavage&#xD;
Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites</description>
          </group>
          <group group_id="O2">
            <title>Laparoscopically Approached Sigmoidectomy</title>
            <description>Patients who have a laparoscopically approached sigmoidectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Short-term Morbidity</title>
          <population>In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection</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="27"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Short-term Mortality</title>
        <time_frame>30 days</time_frame>
        <population>In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection</population>
        <group_list>
          <group group_id="O1">
            <title>Laparoscopic Peritoneal Lavage</title>
            <description>Patients who undergo Laparoscopic Peritoneal Lavage&#xD;
Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites</description>
          </group>
          <group group_id="O2">
            <title>Laparoscopically Approached Sigmoidectomy</title>
            <description>Patients who have a laparoscopically approached sigmoidectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Short-term Mortality</title>
          <population>In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection</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="27"/>
                <count group_id="O2" value="38"/>
              </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>Primary</type>
        <title>Optimal Sepsis Control</title>
        <time_frame>30 days</time_frame>
        <population>In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection</population>
        <group_list>
          <group group_id="O1">
            <title>Laparoscopic Peritoneal Lavage</title>
            <description>Patients who undergo Laparoscopic Peritoneal Lavage&#xD;
Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites</description>
          </group>
          <group group_id="O2">
            <title>Laparoscopically Approached Sigmoidectomy</title>
            <description>Patients who have a laparoscopically approached sigmoidectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Optimal Sepsis Control</title>
          <population>In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection</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="27"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Post-operative Re-interventions Rate</title>
        <time_frame>15 days</time_frame>
        <population>In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection</population>
        <group_list>
          <group group_id="O1">
            <title>Laparoscopic Peritoneal Lavage</title>
            <description>Patients who undergo Laparoscopic Peritoneal Lavage&#xD;
Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites</description>
          </group>
          <group group_id="O2">
            <title>Laparoscopically Approached Sigmoidectomy</title>
            <description>Patients who have a laparoscopically approached sigmoidectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Re-interventions Rate</title>
          <population>In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection</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="27"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Postoperative Time</title>
        <time_frame>1 day</time_frame>
        <population>In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection</population>
        <group_list>
          <group group_id="O1">
            <title>Laparoscopic Peritoneal Lavage</title>
            <description>Patients who undergo Laparoscopic Peritoneal Lavage&#xD;
Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites</description>
          </group>
          <group group_id="O2">
            <title>Laparoscopically Approached Sigmoidectomy</title>
            <description>Patients who have a laparoscopically approached sigmoidectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Postoperative Time</title>
          <population>In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.74" spread="33.18"/>
                    <measurement group_id="O2" value="225.36" spread="81.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Length of Postoperative Hospital Stay</title>
        <time_frame>30 day</time_frame>
        <population>In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection</population>
        <group_list>
          <group group_id="O1">
            <title>Laparoscopic Peritoneal Lavage</title>
            <description>Patients who undergo Laparoscopic Peritoneal Lavage&#xD;
Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites</description>
          </group>
          <group group_id="O2">
            <title>Laparoscopically Approached Sigmoidectomy</title>
            <description>Patients who have a laparoscopically approached sigmoidectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Average Length of Postoperative Hospital Stay</title>
          <population>In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" spread="9.60"/>
                    <measurement group_id="O2" value="8.23" spread="5.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Recurrent Colonic Diverticulitis Rate</title>
        <time_frame>6 months</time_frame>
        <population>In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection</population>
        <group_list>
          <group group_id="O1">
            <title>Laparoscopic Peritoneal Lavage</title>
            <description>Patients who undergo Laparoscopic Peritoneal Lavage&#xD;
Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites</description>
          </group>
          <group group_id="O2">
            <title>Laparoscopically Approached Sigmoidectomy</title>
            <description>Patients who have a laparoscopically approached sigmoidectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Recurrent Colonic Diverticulitis Rate</title>
          <population>In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection</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="27"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incisional Hernia Rate</title>
        <time_frame>6 months</time_frame>
        <population>In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection</population>
        <group_list>
          <group group_id="O1">
            <title>Laparoscopic Peritoneal Lavage</title>
            <description>Patients who undergo Laparoscopic Peritoneal Lavage&#xD;
Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites</description>
          </group>
          <group group_id="O2">
            <title>Laparoscopically Approached Sigmoidectomy</title>
            <description>Patients who have a laparoscopically approached sigmoidectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Incisional Hernia Rate</title>
          <population>In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection</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="27"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Laparoscopic Peritoneal Lavage</title>
          <description>Patients who undergo Laparoscopic Peritoneal Lavage&#xD;
Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites</description>
        </group>
        <group group_id="E2">
          <title>Laparoscopically Approached Sigmoidectomy</title>
          <description>Patients who have a laparoscopically approached sigmoidectomy</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="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Dario Tartaglia</name_or_title>
      <organization>University of Pusa</organization>
      <phone>+393334491229</phone>
      <email>dario261184@gmail.com</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/NCT03008707
org study id: n° 890
nct id: NCT03008707
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
Laparoscopic peritoneal lavage (LPL) has recently been emerging as an effective alternative
      to laparoscopic sigmoidectomy (LS) in patients with complicated acute diverticulitis (CAD)
      (Modified Hinchey's classification grade II non-responder to conservative therapy and grade
      III). Aim of the study is to evaluate which surgical strategy, between LPL and LS, could give
      better results in patients with CAD
In the literature, there is no consensus about the role of the laparoscopic peritoneal lavage
      in the management of complicated acute diverticulitis. Recently, three important prospective
      randomized-control studies (SCANDIV, LOLA, DILALA) have reported contradicting conclusions,
      as two of them (SCANDIV and LOLA) state that LPL is not superior to sigmoidectomy for the
      high reoperation rate and morbidity, while DILALA confirms that LPL is feasible and safe in
      the short-term. To our knowledge, no international guidelines promote the use of LPL in
      complicated acute diverticulitis. We believe this technique could be safely used in a
      selected cohort of patients and, in some circumstances, could represent a "bridge" to a
      possible planned resection. The aim of the study is to collect and analyze the multicentric
      data of the LPL and LS and give a substantial contribution to the scientific community about
      this very debated topic.
observational model: Case-Control
time perspective: Prospective
measure: Short-term Morbidity
time frame: 30 days
measure: Short-term Mortality
time frame: 30 days
measure: Optimal Sepsis Control
time frame: 30 days
measure: Post-operative Re-interventions Rate
time frame: 15 days
measure: Mean Postoperative Time
time frame: 1 day
measure: Average Length of Postoperative Hospital Stay
time frame: 30 day
measure: Recurrent Colonic Diverticulitis Rate
time frame: 6 months
measure: Incisional Hernia Rate
time frame: 6 months
arm group label: Group 1
description: Patients who undergo Laparoscopic Peritoneal Lavage
arm group label: Group 2
description: Patients who have a laparoscopically approached sigmoidectomy
intervention type: Procedure
intervention name: Laparoscopic Peritoneal Lavage
description: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites
arm group label: Group 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dario Tartaglia, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero, Universitaria Pisana
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliero, Universitaria Pisana
investigator full name: Dario Tartaglia
investigator title: MD, PhD Candidate
mesh term: Diverticulitis
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 