<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/NCT03757650</url>
  </required_header>
  <id_info>
    <org_study_id>ANIL ERGIN</org_study_id>
    <nct_id>NCT03757650</nct_id>
  </id_info>
  <brief_title>THE EFFECT OF HELICOBACTER PYLORI ERADICATION THERAPY TO GASTRIC WALL THICKNESS BEFORE THE LAPAROSCOPIC SLEEVE GASTRECTOMY</brief_title>
  <official_title>THE EFFECT OF HELICOBACTER PYLORI ERADICATION THERAPY TO GASTRIC WALL THICKNESS BEFORE THE LAPAROSCOPIC SLEEVE GASTRECTOMY</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>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Laparoscopic sleeve gastrectomy is one of the most popular bariatric surgery in the world.&#xD;
      The most important complication about this surgery that the leakage from the stapler line&#xD;
      because of the inconvenient stapler choice..The stapler colour has to be chosen to the&#xD;
      gastric wall thickness. It is not known well that the effect of Helicobacter pylori to&#xD;
      gastric wall thickness Nobody pay any attention about being Helicobacter pylori positive when&#xD;
      they are choosing stapler colour during the Laparoscopic sleeve gastrectomy so that everybody&#xD;
      use the same type of stapler in Helicobacter pylori positive and negative patients during the&#xD;
      Laparoscopic sleeve gastrectomy .Because of this inconvenient staplers use in the&#xD;
      Laparoscopic sleeve gastrectomy the risk of leakage would be increase. Purpose of this&#xD;
      research is that what is the effect of Helicobacter pylori to the gastric wall thickness and&#xD;
      if the patients who will undergo Laparoscopic sleeve gastrectomy take the Helicobacter pylori&#xD;
      eradication therapy before the surgery will gastric wall thickness increase or decrease. .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients who will undergo to Laparoscopic sleeve gastrectomy have upper gastrointestinal&#xD;
      system endoscopy before the surgery in our clinical routine. In our research some patients&#xD;
      who has Helicobacter pylori positive endoscopic biopsy will take Helicobacter pylori&#xD;
      eradication therapy one month before the surgery and some patients will not take any&#xD;
      medication about Helicobacter pylori. All of gastric specimens( Helicobacter pylori positive&#xD;
      or negative ) will examine microscopically in the pathology laboratory. The two groups which&#xD;
      preoperatively Helicobacter pylori positive detected in endoscopic biopsy will compare with&#xD;
      Helicobacter pylori negative control group. Control group will include 30 patients. The other&#xD;
      two groups will include 44 patients for each group . The number of patients of group has been&#xD;
      determined by power analysis. Gastric specimen will be examined by 3 points ; fundus, corpus,&#xD;
      antrum. All of microscopic measurements will be done from that points from minor curvatura.&#xD;
      These 3 points ; fundus( 1 cm from the top of staple line) , corpus (middle of the staple&#xD;
      line) , antrum ( 1 cm far from the bottom of staple line ). All these points 5 mm far from&#xD;
      the minor curvatura. These 3 points will examine about wall thickness (mucosa-&#xD;
      submucosa-muscularis propria -serosa ) and the status of Helicobacter pylori. The end of the&#xD;
      study it can be determined the effect of Helicobacter pylori to the gastric wall thickness.&#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, 2020</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>measurements of gastric wall thickness</measure>
    <time_frame>one month</time_frame>
    <description>The effect of Helicobacter Pylori eradication therapy to the gastric wall thickness</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Choosing the correct stapler colour during Laparoscopic Sleeve Gastrectomy by accounting gastric wall thickness thanks to knowing effect of HP positivity to gastric wall thickness</measure>
    <time_frame>one month</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Helicobacter Pylori Infection</condition>
  <condition>Obesity, Morbid</condition>
  <arm_group>
    <arm_group_label>HP eradication therapy positive-HP positive</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>who has HP positive endoscopic biopsy will take HP eradication therapy one month before the surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HP eradication therapy negative-HP positive</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>who has HP positive endoscopic biopsy and will not take any medication about HP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HP negative-Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>who has HP negative endoscopic biopsy and will not take any medication. (control group)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bismuth Subsalicylate</intervention_name>
    <description>omeprazole 2x1) + clarithromycin 2x500 mg + amoxicilline 2x1000 mg + Bismuth Subsalicylate 2x1</description>
    <arm_group_label>HP eradication therapy negative-HP positive</arm_group_label>
    <arm_group_label>HP eradication therapy positive-HP positive</arm_group_label>
    <other_name>amoxicillin</other_name>
    <other_name>clarithromycin</other_name>
    <other_name>omeprazole</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients who will undergo to LSG will have upper gastrointestinal system endoscopy&#xD;
             before the surgery and positive HP results.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having allergy to the medications which use for the HP eradication therapy&#xD;
&#xD;
          -  The patients who is incompatible for the HP eradication therapy&#xD;
&#xD;
          -  The patients who decided to undergo to another bariatric surgery peroperatively&#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>Dr Anil ERGIN , General Surgery , Asistant doctor</investigator_title>
  </responsible_party>
  <keyword>obesity</keyword>
  <keyword>laparoscopic sleeve gastrectomy</keyword>
  <keyword>helicobacter pylori</keyword>
  <keyword>gastric wall thickness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Clarithromycin</mesh_term>
    <mesh_term>Omeprazole</mesh_term>
    <mesh_term>Bismuth</mesh_term>
    <mesh_term>Bismuth subsalicylate</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/NCT03757650
org study id: ANIL ERGIN
nct id: NCT03757650
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
Laparoscopic sleeve gastrectomy is one of the most popular bariatric surgery in the world.
      The most important complication about this surgery that the leakage from the stapler line
      because of the inconvenient stapler choice..The stapler colour has to be chosen to the
      gastric wall thickness. It is not known well that the effect of Helicobacter pylori to
      gastric wall thickness Nobody pay any attention about being Helicobacter pylori positive when
      they are choosing stapler colour during the Laparoscopic sleeve gastrectomy so that everybody
      use the same type of stapler in Helicobacter pylori positive and negative patients during the
      Laparoscopic sleeve gastrectomy .Because of this inconvenient staplers use in the
      Laparoscopic sleeve gastrectomy the risk of leakage would be increase. Purpose of this
      research is that what is the effect of Helicobacter pylori to the gastric wall thickness and
      if the patients who will undergo Laparoscopic sleeve gastrectomy take the Helicobacter pylori
      eradication therapy before the surgery will gastric wall thickness increase or decrease. .
All patients who will undergo to Laparoscopic sleeve gastrectomy have upper gastrointestinal
      system endoscopy before the surgery in our clinical routine. In our research some patients
      who has Helicobacter pylori positive endoscopic biopsy will take Helicobacter pylori
      eradication therapy one month before the surgery and some patients will not take any
      medication about Helicobacter pylori. All of gastric specimens( Helicobacter pylori positive
      or negative ) will examine microscopically in the pathology laboratory. The two groups which
      preoperatively Helicobacter pylori positive detected in endoscopic biopsy will compare with
      Helicobacter pylori negative control group. Control group will include 30 patients. The other
      two groups will include 44 patients for each group . The number of patients of group has been
      determined by power analysis. Gastric specimen will be examined by 3 points ; fundus, corpus,
      antrum. All of microscopic measurements will be done from that points from minor curvatura.
      These 3 points ; fundus( 1 cm from the top of staple line) , corpus (middle of the staple
      line) , antrum ( 1 cm far from the bottom of staple line ). All these points 5 mm far from
      the minor curvatura. These 3 points will examine about wall thickness (mucosa-
      submucosa-muscularis propria -serosa ) and the status of Helicobacter pylori. The end of the
      study it can be determined the effect of Helicobacter pylori to the gastric wall thickness.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: measurements of gastric wall thickness
time frame: one month
description: The effect of Helicobacter Pylori eradication therapy to the gastric wall thickness
measure: Choosing the correct stapler colour during Laparoscopic Sleeve Gastrectomy by accounting gastric wall thickness thanks to knowing effect of HP positivity to gastric wall thickness
time frame: one month
arm group label: HP eradication therapy positive-HP positive
arm group type: Active Comparator
description: who has HP positive endoscopic biopsy will take HP eradication therapy one month before the surgery
arm group label: HP eradication therapy negative-HP positive
arm group type: Active Comparator
description: who has HP positive endoscopic biopsy and will not take any medication about HP
arm group label: HP negative-Control group
arm group type: No Intervention
description: who has HP negative endoscopic biopsy and will not take any medication. (control group)
intervention type: Drug
intervention name: Bismuth Subsalicylate
description: omeprazole 2x1) + clarithromycin 2x500 mg + amoxicilline 2x1000 mg + Bismuth Subsalicylate 2x1
arm group label: HP eradication therapy negative-HP positive
arm group label: HP eradication therapy positive-HP positive
other name: amoxicillin
other name: clarithromycin
other name: omeprazole
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: Obesity, Morbid
mesh term: Amoxicillin
mesh term: Clarithromycin
mesh term: Omeprazole
mesh term: Bismuth
mesh term: Bismuth subsalicylate
sharing ipd: No