<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/NCT01726231</url>
  </required_header>
  <id_info>
    <org_study_id>BEH GynObs-2</org_study_id>
    <nct_id>NCT01726231</nct_id>
  </id_info>
  <brief_title>Evaluation of Abdominal Wall Lifting During Laparoscopic Direct Trocar Insertion</brief_title>
  <official_title>Evaluation of Abdominal Wall Lifting During Laparoscopic Direct Trocar Insertion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bagcilar Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bagcilar Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In laparoscopy, over %50 of the all complications occur during establishment of the&#xD;
      pneumoperitoneum. Lifting of the anterior abdominal wall is aimed to increase the distance&#xD;
      between the abdominal wall and the intrabdominal structures. Elevation of the anterior&#xD;
      abdominal wall is recommended for the access to peritoneal cavity in literatures however the&#xD;
      benefit exactly has not proved. This study aimed to determine the distance from anterior&#xD;
      abdominal wall to intraperitoneal structures during lifting of the abdominal wall, to&#xD;
      represent this distance -on the average- generate the safe range whether or not and compare&#xD;
      with this distance and patient's age, BMI and parity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      40 patients who undergoing laparoscopic surgery for various indications are enrolled in the&#xD;
      study. The telescope is inserted at second trocar place and the distances between anterior&#xD;
      abdominal wall and visceral organs are measured with plastic hysterometry during maximal&#xD;
      elevation of the abdominal wall.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The primary outcome measure of this study is to determine the distance in centimeters from anterior abdominal wall to intraperitoneal visceral structures during lifting of the abdominal wall with plastic hysterometry.</measure>
    <time_frame>2-3 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Other Surgical Procedures</condition>
  <eligibility>
    <study_pop>
      <textblock>
        the patiens undergoing laparoscopic surgery for various indications&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the patients who performed laparoscopic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the patients who suspected pregnancy&#xD;
&#xD;
          -  large scale intrabdominal mass&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>TANER A USTA, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bagcilar Training and Research Hospital, Istanbul, Turkey</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bagcilar Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>December 24, 2013</last_update_submitted>
  <last_update_submitted_qc>December 24, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 25, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Laparoscopic access</keyword>
  <keyword>Abdominal wall lifting</keyword>
  <keyword>Direct trocar insertion</keyword>
  <keyword>Safety endoscopy</keyword>
  <!-- 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/NCT01726231
org study id: BEH GynObs-2
nct id: NCT01726231
lead sponsor: 
has dmc: No
In laparoscopy, over %50 of the all complications occur during establishment of the
      pneumoperitoneum. Lifting of the anterior abdominal wall is aimed to increase the distance
      between the abdominal wall and the intrabdominal structures. Elevation of the anterior
      abdominal wall is recommended for the access to peritoneal cavity in literatures however the
      benefit exactly has not proved. This study aimed to determine the distance from anterior
      abdominal wall to intraperitoneal structures during lifting of the abdominal wall, to
      represent this distance -on the average- generate the safe range whether or not and compare
      with this distance and patient's age, BMI and parity.
40 patients who undergoing laparoscopic surgery for various indications are enrolled in the
      study. The telescope is inserted at second trocar place and the distances between anterior
      abdominal wall and visceral organs are measured with plastic hysterometry during maximal
      elevation of the abdominal wall.
observational model: Case-Only
time perspective: Cross-Sectional
measure: The primary outcome measure of this study is to determine the distance in centimeters from anterior abdominal wall to intraperitoneal visceral structures during lifting of the abdominal wall with plastic hysterometry.
time frame: 2-3 months
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: TANER A USTA, M.D.
role: Principal Investigator
affiliation: Bagcilar Training and Research Hospital, Istanbul, Turkey
facility: 
country: Turkey
responsible party type: Sponsor