<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/NCT03240367</url>
  </required_header>
  <id_info>
    <org_study_id>2016/180</org_study_id>
    <nct_id>NCT03240367</nct_id>
  </id_info>
  <brief_title>Comparison of Stapler Line Bleeding Control Techniquessurgery</brief_title>
  <official_title>Comparison of Stapler Line Bleeding Control Techniques in Laparoscopic Gastric Bypass</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ersin Gündoğan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inonu University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with&#xD;
      improvements in minimally invasive surgery. Ensuring patient comfort and early return to life&#xD;
      are the criteria that should be given priority in this treatment method.The purpose of this&#xD;
      study; Emphasizing that the cautery technique of the stapler line bleeding control methods is&#xD;
      as successful as the other methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The question of the availability of cautery in RYGB surgeons&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 4, 2016</start_date>
  <completion_date type="Actual">July 14, 2017</completion_date>
  <primary_completion_date type="Actual">July 14, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>3-item drainage control</measure>
    <time_frame>8 months</time_frame>
    <description>Bleeding quantities to be noted</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Obesity, Morbid</condition>
  <arm_group>
    <arm_group_label>coutery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stapler bloom will be stopped with cautery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>clips</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Stapler bloom will be stopped with clipping</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Coutery</intervention_name>
    <description>Stapler line bleeding control with coutery</description>
    <arm_group_label>coutery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Morbid obese patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries&#xD;
             during LRYGBP and those who had previously undergone obesity surgery (revision&#xD;
             surgery)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ersin Gündoğan, MD</last_name>
    <role>Study Director</role>
    <affiliation>study principal investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inonu University</name>
      <address>
        <city>Malatya</city>
        <zip>44915</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 4, 2017</last_update_submitted>
  <last_update_submitted_qc>August 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Inonu University</investigator_affiliation>
    <investigator_full_name>Ersin Gündoğan</investigator_full_name>
    <investigator_title>operator doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03240367
org study id: 2016/180
nct id: NCT03240367
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with
      improvements in minimally invasive surgery. Ensuring patient comfort and early return to life
      are the criteria that should be given priority in this treatment method.The purpose of this
      study; Emphasizing that the cautery technique of the stapler line bleeding control methods is
      as successful as the other methods.
The question of the availability of cautery in RYGB surgeons
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 3-item drainage control
time frame: 8 months
description: Bleeding quantities to be noted
arm group label: coutery
arm group type: Experimental
description: Stapler bloom will be stopped with cautery
arm group label: clips
arm group type: No Intervention
description: Stapler bloom will be stopped with clipping
intervention type: Other
intervention name: Coutery
description: Stapler line bleeding control with coutery
arm group label: coutery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ersin Gündoğan, MD
role: Study Director
affiliation: study principal investigator
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Inonu University
investigator full name: Ersin Gündoğan
investigator title: operator doctor
mesh term: Obesity, Morbid
sharing ipd: No