<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/NCT03795844</url>
  </required_header>
  <id_info>
    <org_study_id>ANIL ERGIN.......</org_study_id>
    <nct_id>NCT03795844</nct_id>
  </id_info>
  <brief_title>COMPARISON OF LIVER RETRACTOR FOR INTRATOPERATIVE LIVER DAMAGE</brief_title>
  <acronym>RETRACTOR</acronym>
  <official_title>COMPARISON OF LIVER RETRACTOR USED IN LAPAROSCOPIC SLEEVE GASTRECTOMY BY INTRAOPERATIVE LIVER DAMAGE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fatih Sultan Mehmet Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fatih Sultan Mehmet Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      The frequency of laparoscopic bariatric surgery is increasing day by day. In these surgeries,&#xD;
      the liver masses are also found to be significantly larger due to the high Body Mass Index&#xD;
      scores. It is known that the application of a diet called liver shrinkage protein diet which&#xD;
      is applied preoperatively is a method that contributes to the comfort of the surgeon during&#xD;
      surgery by reducing the size of the liver. The large size of the liver narrows the field of&#xD;
      view of the surgeon in operation and decreases the comfort of surgery. One of the most&#xD;
      important points that the surgeon must solve during surgery is the exclusion of the left lobe&#xD;
      of the liver. The most commonly used types of liver retractors today; Nathanson retractor,&#xD;
      Snowden-Window retractor, Snake retractor, Fan retractor, LIvac retractor and many other&#xD;
      retractors. Some of these retractors require an additional incision under xiphoid, which may&#xD;
      lead to an injury risk. The installation of these retractors also increases the operation&#xD;
      time and requires additional time. Numerous studies have shown that retractors, which are&#xD;
      used to rule out liver left lobe during surgery, cause liver damage. However, in order to&#xD;
      reveal His angle in the esophageal-gastric composition, hepatic left lobe exclusion is&#xD;
      mandatory. Therefore, it is necessary to determine and use the retractor type which causes&#xD;
      the least damage between the liver retractors. In our study, it was aimed to reveal three&#xD;
      types of liver retractors in our hospital in different cases and to reveal the type of trocar&#xD;
      that causes the least amount of liver damage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During laparoscopic upper abdominal surgery, the operative view is usually blocked by the&#xD;
      left lobe of the liver. An effective liver retraction is important for good vision and safety&#xD;
      during operation. In this study, 120 patients who are over 18 years old with laparoscopic&#xD;
      sleeve gastrectomy will be included. 4 groups will be formed and each group will be planned&#xD;
      to include 30 patients. In group 1, a 5 mm incision was made under xiphoid during the&#xD;
      operation, and Nathanson retractor was placed and liver left lobe retraction would be&#xD;
      achieved. In the second group, a snake retractor with a 5 mm incision under the xiphoid will&#xD;
      be used. In the 3rd group, liver retraction will be provided by using a 5 mm trocar from the&#xD;
      intersection of the right midclavicular line. In the group, liver retraction through a 5 mm&#xD;
      trocar entrained from the intersection of the right midclavicular line and a 4 cm superior&#xD;
      umbilicus will be provided with the aid of laparoscopic grasper without any special tools. In&#xD;
      these patients, aspartate aminotransferase, alanine aminotransferase and Bilirubin levels&#xD;
      will be examined on the postoperative 1st, 2nd and 3rd days and the patients will be examined&#xD;
      with postoperative first day abdominal abdomen magnetic resonance imaging and the liver&#xD;
      injury will be evaluated by the radiologist. Patients will not know which liver excision&#xD;
      method is used during surgery. The radiologist who will perform damage assessment on imaging&#xD;
      will not know which type of liver dislocation is used. Therefore, the study will be planned&#xD;
      as double blind. The liver excision method will be applied sequentially. Randomization will&#xD;
      be done in this way.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Actual">February 1, 2021</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</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>Crossover Assignment</intervention_model>
    <intervention_model_description>In this study, 120 patients who are over 18 years old with laparoscopic sleeve gastrectomy will be included. 4 groups will be formed and each group will be planned to include 30 patients. In group 1, a 5 mm incision was made under xiphoid during the operation, and Nathanson retractor was placed and liver left lobe retraction would be achieved. In the second group, a snake retractor with a 5 mm incision under the xiphoid will be used. In the 3rd group, liver retraction will be provided by using a 5 mm trocar from the intersection of the right midclavicular line. In the control group, liver retraction through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus will be provided with the aid of laparoscopic grasper without any special tools.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Liver damage of liver retractors by measurement of AST(Aspartate Aminotransferase), ALT (alanine aminotransferase) , GGT (Gamma-Glutamyl Transferase) , Bilirubin (Total , direct , indirect ) levels.</measure>
    <time_frame>72 hours</time_frame>
    <description>measurement of AST(Aspartate Aminotransferase), ALT (alanine aminotransferase) , GGT (Gamma-Glutamyl Transferase) , Bilirubin (Total , direct , indirect ) levels will be measured preoperatively and postoperative 0 , 1 , 2 , 3 days and record.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Liver Damage</condition>
  <arm_group>
    <arm_group_label>Nathanson retractor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Liver retraction in group 1, a 5 mm incision was made under xiphoid during the operation, and Nathanson retractor was placed and liver left lobe retraction would be achieved.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>snake retractor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Liver retraction in group 2 ; 5 mm incision under the xiphoid will be used. Snake retractor was placed and liver left lobe retraction would be achieved.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fan retractor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Liver retraction in group 3 ; through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROL GROUP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Liver retraction in group 4 ; through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus will be provided with the aid of laparoscopic grasper without any special tools</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>liver retraction Nathanson retractor</intervention_name>
    <description>liver retractor will be used for the retraction of left lobe of liver</description>
    <arm_group_label>Nathanson retractor</arm_group_label>
    <other_name>nathanson retractor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>liver retraction snake retractor</intervention_name>
    <description>liver retractor will be used for the retraction of left lobe of liver</description>
    <arm_group_label>snake retractor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>liver retraction fan retractor</intervention_name>
    <description>liver retractor will be used for the retraction of left lobe of liver</description>
    <arm_group_label>fan retractor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>liver retraction laparoscopic grasper</intervention_name>
    <description>laparoscopic grasper without any special tools</description>
    <arm_group_label>CONTROL GROUP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patients older than 18 years planned for Laparoscopic Sleeve Gastrectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patients with liver failure&#xD;
&#xD;
          -  The patients with impaired preoperative liver function tests&#xD;
&#xD;
          -  The patients who have been diagnosed with any liver disease&#xD;
&#xD;
          -  The patients with bleeding disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fatih Sultan Mehmet Research and Training Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34734</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>March 19, 2021</last_update_submitted>
  <last_update_submitted_qc>March 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fatih Sultan Mehmet Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>ANIL ERGIN</investigator_full_name>
    <investigator_title>Dr Anil ERGIN , General Surgery , Asistant doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Extracts</mesh_term>
  </intervention_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/NCT03795844
org study id: ANIL ERGIN.......
nct id: NCT03795844
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The frequency of laparoscopic bariatric surgery is increasing day by day. In these surgeries,
      the liver masses are also found to be significantly larger due to the high Body Mass Index
      scores. It is known that the application of a diet called liver shrinkage protein diet which
      is applied preoperatively is a method that contributes to the comfort of the surgeon during
      surgery by reducing the size of the liver. The large size of the liver narrows the field of
      view of the surgeon in operation and decreases the comfort of surgery. One of the most
      important points that the surgeon must solve during surgery is the exclusion of the left lobe
      of the liver. The most commonly used types of liver retractors today; Nathanson retractor,
      Snowden-Window retractor, Snake retractor, Fan retractor, LIvac retractor and many other
      retractors. Some of these retractors require an additional incision under xiphoid, which may
      lead to an injury risk. The installation of these retractors also increases the operation
      time and requires additional time. Numerous studies have shown that retractors, which are
      used to rule out liver left lobe during surgery, cause liver damage. However, in order to
      reveal His angle in the esophageal-gastric composition, hepatic left lobe exclusion is
      mandatory. Therefore, it is necessary to determine and use the retractor type which causes
      the least damage between the liver retractors. In our study, it was aimed to reveal three
      types of liver retractors in our hospital in different cases and to reveal the type of trocar
      that causes the least amount of liver damage.
During laparoscopic upper abdominal surgery, the operative view is usually blocked by the
      left lobe of the liver. An effective liver retraction is important for good vision and safety
      during operation. In this study, 120 patients who are over 18 years old with laparoscopic
      sleeve gastrectomy will be included. 4 groups will be formed and each group will be planned
      to include 30 patients. In group 1, a 5 mm incision was made under xiphoid during the
      operation, and Nathanson retractor was placed and liver left lobe retraction would be
      achieved. In the second group, a snake retractor with a 5 mm incision under the xiphoid will
      be used. In the 3rd group, liver retraction will be provided by using a 5 mm trocar from the
      intersection of the right midclavicular line. In the group, liver retraction through a 5 mm
      trocar entrained from the intersection of the right midclavicular line and a 4 cm superior
      umbilicus will be provided with the aid of laparoscopic grasper without any special tools. In
      these patients, aspartate aminotransferase, alanine aminotransferase and Bilirubin levels
      will be examined on the postoperative 1st, 2nd and 3rd days and the patients will be examined
      with postoperative first day abdominal abdomen magnetic resonance imaging and the liver
      injury will be evaluated by the radiologist. Patients will not know which liver excision
      method is used during surgery. The radiologist who will perform damage assessment on imaging
      will not know which type of liver dislocation is used. Therefore, the study will be planned
      as double blind. The liver excision method will be applied sequentially. Randomization will
      be done in this way.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: In this study, 120 patients who are over 18 years old with laparoscopic sleeve gastrectomy will be included. 4 groups will be formed and each group will be planned to include 30 patients. In group 1, a 5 mm incision was made under xiphoid during the operation, and Nathanson retractor was placed and liver left lobe retraction would be achieved. In the second group, a snake retractor with a 5 mm incision under the xiphoid will be used. In the 3rd group, liver retraction will be provided by using a 5 mm trocar from the intersection of the right midclavicular line. In the control group, liver retraction through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus will be provided with the aid of laparoscopic grasper without any special tools.
primary purpose: Prevention
masking: None (Open Label)
measure: Liver damage of liver retractors by measurement of AST(Aspartate Aminotransferase), ALT (alanine aminotransferase) , GGT (Gamma-Glutamyl Transferase) , Bilirubin (Total , direct , indirect ) levels.
time frame: 72 hours
description: measurement of AST(Aspartate Aminotransferase), ALT (alanine aminotransferase) , GGT (Gamma-Glutamyl Transferase) , Bilirubin (Total , direct , indirect ) levels will be measured preoperatively and postoperative 0 , 1 , 2 , 3 days and record.
arm group label: Nathanson retractor
arm group type: Active Comparator
description: Liver retraction in group 1, a 5 mm incision was made under xiphoid during the operation, and Nathanson retractor was placed and liver left lobe retraction would be achieved.
arm group label: snake retractor
arm group type: Active Comparator
description: Liver retraction in group 2 ; 5 mm incision under the xiphoid will be used. Snake retractor was placed and liver left lobe retraction would be achieved.
arm group label: fan retractor
arm group type: Active Comparator
description: Liver retraction in group 3 ; through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus
arm group label: CONTROL GROUP
arm group type: Active Comparator
description: Liver retraction in group 4 ; through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus will be provided with the aid of laparoscopic grasper without any special tools
intervention type: Procedure
intervention name: liver retraction Nathanson retractor
description: liver retractor will be used for the retraction of left lobe of liver
arm group label: Nathanson retractor
other name: nathanson retractor
intervention type: Procedure
intervention name: liver retraction snake retractor
description: liver retractor will be used for the retraction of left lobe of liver
arm group label: snake retractor
intervention type: Procedure
intervention name: liver retraction fan retractor
description: liver retractor will be used for the retraction of left lobe of liver
arm group label: fan retractor
intervention type: Procedure
intervention name: liver retraction laparoscopic grasper
description: laparoscopic grasper without any special tools
arm group label: CONTROL GROUP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Fatih Sultan Mehmet Training and Research Hospital
investigator full name: ANIL ERGIN
investigator title: Dr Anil ERGIN , General Surgery , Asistant doctor
mesh term: Liver Diseases
mesh term: Liver Extracts
sharing ipd: No