<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/NCT03757624</url>
  </required_header>
  <id_info>
    <org_study_id>ANIL ERGIN.</org_study_id>
    <nct_id>NCT03757624</nct_id>
  </id_info>
  <brief_title>TISSUE SHRINKAGE DEPENDS ON FORMOL SOLUTION IN DIFFERENT GASTRIC LOCATIONS</brief_title>
  <acronym>SHRINKAGE</acronym>
  <official_title>TISSUE SHRINKAGE DEPENDS ON FORMOL SOLUTION IN DIFFERENT GASTRIC LOCATIONS</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>
      Generally % 10 formol solution is use to do fixation to all specimens after the surgical&#xD;
      operations for the pathological evaluation. It is known that the formol solution cause amount&#xD;
      of shrinkage in the tissue volume . This effect of formol solution had researched in&#xD;
      colon,breast and prostate previously. But there is no evidence about stomach. The purpose of&#xD;
      this research is that find out the formol effect to the gastric tissue and detect the&#xD;
      shrinkage percent.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All gastric specimens which removed after Laparoscopic Sleeve Gastrectomy will open from the&#xD;
      major curvature and spread down to the table.in operating room..3 cm x 3 cm three tissue&#xD;
      samples will collect from the specific locations. These three locations are ; fundus( 1 cm&#xD;
      from the top of staple line) , corpus (middle of the major curvature , antrum ( 1 cm far from&#xD;
      the bottom of staple line ). All these points 5 mm far from the major curvature. 6 samples&#xD;
      will prepare totally. 2 samples for each location ; one mucosa and one all layer of gastric&#xD;
      wall for each location .These 3 points will examine about wall thickness(mucosa-&#xD;
      submucosa-muscularis propria -serosa ) After saving the measurements in operating room;the&#xD;
      gastric specimen will deliver to a pathologist to put the specimen into the % 10 formol&#xD;
      solution. After 24 hours ;pathologist will save all of new measurements same in operating&#xD;
      room. The measurements of sample are ;height , length , width . After the completion of the&#xD;
      measurements the investigator will compare the results found in operating room in fresh&#xD;
      specimen with pathologist 's results after formol. After that the investigator will be able&#xD;
      to decide the shrinkage of gastric tissue in % 10 formol solution.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">February 1, 2021</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>shrinkage in gastric tissue</measure>
    <time_frame>24 hours</time_frame>
    <description>shrinkage of gastric specimen in %10 formol solution after Laparoscopic Sleeve Gastrectomy</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Shrinking Stomach</condition>
  <arm_group>
    <arm_group_label>Gastric specimen measurements after 24 hours from % 10 formol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gastric specimens of patients who will undergo to Laparoscopic Sleeve Gastrectomy ,will examine after formol solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gastric specimen measurements after surgery in operating room</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gastric specimens of patients who will undergo to Laparoscopic Sleeve Gastrectomy ,will examine after surgery in operating room peroperatively</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>shrinkage</intervention_name>
    <description>shrinkage of gastric specimen in %10 formol solution after Laparoscopic Sleeve Gastrectomy</description>
    <arm_group_label>Gastric specimen measurements after 24 hours from % 10 formol</arm_group_label>
    <arm_group_label>Gastric specimen measurements after surgery in operating room</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years old who will undergo to Laparoscopic Sleeve Gastrectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who has to undergo another bariatric surgery type peroperatively&#xD;
&#xD;
          -  Deformation of gastric specimen while removing from the abdomen&#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>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</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>asistant doctor</investigator_title>
  </responsible_party>
  <keyword>shrinkage</keyword>
  <keyword>formol</keyword>
  <keyword>stomach</keyword>
  <keyword>gastric wall</keyword>
  <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/NCT03757624
org study id: ANIL ERGIN.
nct id: NCT03757624
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Generally % 10 formol solution is use to do fixation to all specimens after the surgical
      operations for the pathological evaluation. It is known that the formol solution cause amount
      of shrinkage in the tissue volume . This effect of formol solution had researched in
      colon,breast and prostate previously. But there is no evidence about stomach. The purpose of
      this research is that find out the formol effect to the gastric tissue and detect the
      shrinkage percent.
All gastric specimens which removed after Laparoscopic Sleeve Gastrectomy will open from the
      major curvature and spread down to the table.in operating room..3 cm x 3 cm three tissue
      samples will collect from the specific locations. These three locations are ; fundus( 1 cm
      from the top of staple line) , corpus (middle of the major curvature , antrum ( 1 cm far from
      the bottom of staple line ). All these points 5 mm far from the major curvature. 6 samples
      will prepare totally. 2 samples for each location ; one mucosa and one all layer of gastric
      wall for each location .These 3 points will examine about wall thickness(mucosa-
      submucosa-muscularis propria -serosa ) After saving the measurements in operating room;the
      gastric specimen will deliver to a pathologist to put the specimen into the % 10 formol
      solution. After 24 hours ;pathologist will save all of new measurements same in operating
      room. The measurements of sample are ;height , length , width . After the completion of the
      measurements the investigator will compare the results found in operating room in fresh
      specimen with pathologist 's results after formol. After that the investigator will be able
      to decide the shrinkage of gastric tissue in % 10 formol solution.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: shrinkage in gastric tissue
time frame: 24 hours
description: shrinkage of gastric specimen in %10 formol solution after Laparoscopic Sleeve Gastrectomy
arm group label: Gastric specimen measurements after 24 hours from % 10 formol
arm group type: Active Comparator
description: Gastric specimens of patients who will undergo to Laparoscopic Sleeve Gastrectomy ,will examine after formol solution
arm group label: Gastric specimen measurements after surgery in operating room
arm group type: Active Comparator
description: Gastric specimens of patients who will undergo to Laparoscopic Sleeve Gastrectomy ,will examine after surgery in operating room peroperatively
intervention type: Procedure
intervention name: shrinkage
description: shrinkage of gastric specimen in %10 formol solution after Laparoscopic Sleeve Gastrectomy
arm group label: Gastric specimen measurements after 24 hours from % 10 formol
arm group label: Gastric specimen measurements after surgery in operating room
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: asistant doctor
sharing ipd: No