<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/NCT01734837</url>
  </required_header>
  <id_info>
    <org_study_id>AAG-O-H-1111</org_study_id>
    <nct_id>NCT01734837</nct_id>
  </id_info>
  <brief_title>TICAP - Titanium Clips for Appendiceal Stump Closure</brief_title>
  <acronym>TICAP</acronym>
  <official_title>Prospective Multicenter Observational Study (Registry) on the Aesculap DS Titanium Ligation Clips for Appendiceal Stump Closure.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aesculap AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aesculap, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Aesculap AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Laparoscopic appendectomy is progressively accepted as the treatment of choice for acute&#xD;
      appendicitis. Although the surgical technique of laparoscopic appendectomy has been well&#xD;
      established, some controversy exists regarding the closure of the appendiceal stump. The&#xD;
      available methods for stump closure are currently: pre-knotted loops (Roeder Loops or&#xD;
      Endoloop, linear stapler and polymeric clips. A new device is a the DS Titanium Ligation&#xD;
      Clip. The design of the DS-Clip is characterized by two parallel shanks.&#xD;
&#xD;
      The aim of this study is to collect data of a large number of patients treated with the&#xD;
      product in real-life clinical routine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Applicability/feasibility of the DS Clips</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Documentation of the number of successful (= completed stump closure) versus non-successful (= clip could not be applied) applications of the DS-Clip</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intra- and post-operative complications related to surgery</measure>
    <time_frame>30 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of operation</measure>
    <time_frame>intra-operative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conversion rate to open surgery</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospitalization</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">390</enrollment>
  <condition>Appendicitis</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DS-Ligature Clip</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adult patients and children&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          -  indication for a laparoscopic appendectomy&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Inclusion criteria to be checked intraoperatively:&#xD;
&#xD;
          -  conventional laparoscopic approach (no SILS, NOTES, SPA)&#xD;
&#xD;
          -  Aesculap DS Titanium Ligation Clips were used&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  patient age under 16 years&#xD;
&#xD;
          -  appendix is severely inflamed with involvement of the caecum&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Marina del Rey Hospital</name>
      <address>
        <city>Marina del Rey</city>
        <state>California</state>
        <zip>90292</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's University Hospital</name>
      <address>
        <city>Bethlehem,</city>
        <state>Pennsylvania</state>
        <zip>18015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vivantes Humboldt-Klinikum</name>
      <address>
        <city>Berlin</city>
        <zip>13509</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DRK Krankenhaus Clementinen</name>
      <address>
        <city>Hannover</city>
        <zip>30161</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mainz, Department of Surgery</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Mannheim</name>
      <address>
        <city>Mannheim</city>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Memmingen</name>
      <address>
        <city>Memmingen</city>
        <zip>87700</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Katharinenhospital</name>
      <address>
        <city>Stuttgart</city>
        <zip>70174</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH</name>
      <address>
        <city>Villingen-Schwenningen</city>
        <zip>7805</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>United Kingdom</country>
  </removed_countries>
  <results_reference>
    <citation>Rickert A, Kruger CM, Runkel N, Kuthe A, Koninger J, Jansen-Winkeln B, Gutt CN, Marcus DR, Hoey B, Wente MN, Kienle P. The TICAP-Study (titanium clips for appendicular stump closure): A prospective multicentre observational study on appendicular stump closure with an innovative titanium clip. BMC Surg. 2015 Jul 17;15:85. doi: 10.1186/s12893-015-0068-3.</citation>
    <PMID>26185103</PMID>
  </results_reference>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>September 8, 2015</last_update_submitted>
  <last_update_submitted_qc>September 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Laparoscopic appendectomy</keyword>
  <keyword>appendical stump closure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01734837
org study id: AAG-O-H-1111
nct id: NCT01734837
lead sponsor: 
collaborator: 
has dmc: No
Laparoscopic appendectomy is progressively accepted as the treatment of choice for acute
      appendicitis. Although the surgical technique of laparoscopic appendectomy has been well
      established, some controversy exists regarding the closure of the appendiceal stump. The
      available methods for stump closure are currently: pre-knotted loops (Roeder Loops or
      Endoloop, linear stapler and polymeric clips. A new device is a the DS Titanium Ligation
      Clip. The design of the DS-Clip is characterized by two parallel shanks.

      The aim of this study is to collect data of a large number of patients treated with the
      product in real-life clinical routine.
observational model: Cohort
time perspective: Prospective
measure: Applicability/feasibility of the DS Clips
time frame: 30 days after surgery
description: Documentation of the number of successful (= completed stump closure) versus non-successful (= clip could not be applied) applications of the DS-Clip
measure: Intra- and post-operative complications related to surgery
time frame: 30 days after surgery
measure: Duration of operation
time frame: intra-operative
measure: Conversion rate to open surgery
time frame: 30 days
measure: Length of hospitalization
time frame: 30 days
intervention type: Device
intervention name: DS-Ligature Clip
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: United States
country: United Kingdom
citation: Rickert A, Kruger CM, Runkel N, Kuthe A, Koninger J, Jansen-Winkeln B, Gutt CN, Marcus DR, Hoey B, Wente MN, Kienle P. The TICAP-Study (titanium clips for appendicular stump closure): A prospective multicentre observational study on appendicular stump closure with an innovative titanium clip. BMC Surg. 2015 Jul 17;15:85. doi: 10.1186/s12893-015-0068-3.
PMID: 26185103
responsible party type: Sponsor
mesh term: Appendicitis