<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/NCT03015935</url>
  </required_header>
  <id_info>
    <org_study_id>First_Trocar_Entery</org_study_id>
    <nct_id>NCT03015935</nct_id>
  </id_info>
  <brief_title>Safe and Easy Access Technique for the First Trocar in Laparoscopic Obesity Surgery</brief_title>
  <official_title>Safe and Easy Access Technique for the First Trocar in Laparoscopic Obesity Surgery. A Prospective Controlled-cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umraniye Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Umraniye Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Laparoscopic surgery has become very popular and standard in many indications after&#xD;
      advancements of technique. Various methods have been used in first entry to the abdomen.&#xD;
      Safety, wound size, to be not time-consuming, low cost, learning curve and efficacy are&#xD;
      important. Several techniques, instruments, and approaches to minimize the risk of injury&#xD;
      (the bowel, bladder, major abdominal vessels, and an anterior abdominal wall vessel) have&#xD;
      been introduced.&#xD;
&#xD;
      There is no consensus yet on an optimal method has yet emerged.&#xD;
&#xD;
      The investigators aimed to evaluate efficacy of entry methods that ensures safe insertion of&#xD;
      the first trocar at any site of the abdomen.&#xD;
&#xD;
      To evaluate the efficacy of entry technique, the investigators used cohort of patients who&#xD;
      will be planned to laparoscopic obesity surgery.&#xD;
&#xD;
      Two methods are commonly used in surgical literature and in our center.&#xD;
&#xD;
      The investigators have been used visible optical-entry technique in some patients for first&#xD;
      entry and Veress technique in some other patients.&#xD;
&#xD;
      For this purpose, the investigators designed an observational study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several techniques, instruments, and approaches to minimize the risk of injury (the bowel,&#xD;
      bladder, major abdominal vessels, and an anterior abdominal wall vessel) have been&#xD;
      introduced.&#xD;
&#xD;
      These methods include the standard technique of insufflation after insertion of the Veress&#xD;
      needle, the open (Hasson technique), the direct trocar insertion and optical trocar&#xD;
      insertion. Furthermore, it is more difficult to perform in the obese patient, especially if&#xD;
      the first trocar is not umbilical, like obesity surgery. This is because obese patients have&#xD;
      a very thick abdominal wall (particularly in women) as well as a thick peritoneum.&#xD;
&#xD;
      Very different complications, some even potentially fatal, i.e., injury to viscera or to&#xD;
      major intra-abdominal and abdominal wall vessels, have been reported in surgical literature.&#xD;
      Complications of first entry develop in up to 1-2% of patients and more than half of all are&#xD;
      fatal complications. Major vascular and abdominal organ injury rates of 0.03-0.1% and&#xD;
      0.08-0.14%, respectively, have been reported. Surprisingly, there has been little change in&#xD;
      entry techniques since the dawn of laparoscopic surgery. Some risk factors are defined for&#xD;
      prediction of complications, such as obesity. Laparoscopic obesity surgery has become very&#xD;
      attractive and gaining popularity, recently, and however it possess many complications and&#xD;
      challenges such as (it starts with) entry to the abdomen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2010</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</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>Entry time</measure>
    <time_frame>intraoperative</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Obesity, Morbid</condition>
  <arm_group>
    <arm_group_label>Optical</arm_group_label>
    <description>visual-assisted entry</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Veress</arm_group_label>
    <description>Veress entry</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>visual-assisted entry</intervention_name>
    <description>First trocar entry will be performed with visual-assisted trocar</description>
    <arm_group_label>Optical</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Veress entry</intervention_name>
    <description>First trocar entry will be performed with Veress</description>
    <arm_group_label>Veress</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are eligible for laparoscopic obesity surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with body mass index of &gt;40&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have skin disease at operation area&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fatih Basak</last_name>
    <role>Study Chair</role>
    <affiliation>Umraniye Education and Research Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fatih Basak, MD</last_name>
    <phone>5055034571</phone>
    <email>fatihbasak@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Umraniye Education and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Ümraniye</state>
        <zip>34000</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fatih Basak</last_name>
      <phone>5055034571</phone>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 13, 2017</last_update_submitted>
  <last_update_submitted_qc>January 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Umraniye Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Fatih Basak</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Obesity, Morbid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <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/NCT03015935
org study id: First_Trocar_Entery
nct id: NCT03015935
lead sponsor: 
has dmc: Yes
Laparoscopic surgery has become very popular and standard in many indications after
      advancements of technique. Various methods have been used in first entry to the abdomen.
      Safety, wound size, to be not time-consuming, low cost, learning curve and efficacy are
      important. Several techniques, instruments, and approaches to minimize the risk of injury
      (the bowel, bladder, major abdominal vessels, and an anterior abdominal wall vessel) have
      been introduced.

      There is no consensus yet on an optimal method has yet emerged.

      The investigators aimed to evaluate efficacy of entry methods that ensures safe insertion of
      the first trocar at any site of the abdomen.

      To evaluate the efficacy of entry technique, the investigators used cohort of patients who
      will be planned to laparoscopic obesity surgery.

      Two methods are commonly used in surgical literature and in our center.

      The investigators have been used visible optical-entry technique in some patients for first
      entry and Veress technique in some other patients.

      For this purpose, the investigators designed an observational study.
Several techniques, instruments, and approaches to minimize the risk of injury (the bowel,
      bladder, major abdominal vessels, and an anterior abdominal wall vessel) have been
      introduced.

      These methods include the standard technique of insufflation after insertion of the Veress
      needle, the open (Hasson technique), the direct trocar insertion and optical trocar
      insertion. Furthermore, it is more difficult to perform in the obese patient, especially if
      the first trocar is not umbilical, like obesity surgery. This is because obese patients have
      a very thick abdominal wall (particularly in women) as well as a thick peritoneum.

      Very different complications, some even potentially fatal, i.e., injury to viscera or to
      major intra-abdominal and abdominal wall vessels, have been reported in surgical literature.
      Complications of first entry develop in up to 1-2% of patients and more than half of all are
      fatal complications. Major vascular and abdominal organ injury rates of 0.03-0.1% and
      0.08-0.14%, respectively, have been reported. Surprisingly, there has been little change in
      entry techniques since the dawn of laparoscopic surgery. Some risk factors are defined for
      prediction of complications, such as obesity. Laparoscopic obesity surgery has become very
      attractive and gaining popularity, recently, and however it possess many complications and
      challenges such as (it starts with) entry to the abdomen.
observational model: Cohort
time perspective: Prospective
measure: Entry time
time frame: intraoperative
arm group label: Optical
description: visual-assisted entry
arm group label: Veress
description: Veress entry
intervention type: Procedure
intervention name: visual-assisted entry
description: First trocar entry will be performed with visual-assisted trocar
arm group label: Optical
intervention type: Procedure
intervention name: Veress entry
description: First trocar entry will be performed with Veress
arm group label: Veress
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fatih Basak
role: Study Chair
affiliation: Umraniye Education and Research Hospital
last name: Fatih Basak, MD
phone: 5055034571
email: fatihbasak@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Umraniye Education and Research Hospital
investigator full name: Fatih Basak
investigator title: Medical Doctor
mesh term: Obesity
mesh term: Obesity, Morbid
sharing ipd: No