<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/NCT03305432</url>
  </required_header>
  <id_info>
    <org_study_id>fac.med.043</org_study_id>
    <nct_id>NCT03305432</nct_id>
  </id_info>
  <brief_title>Preoperative PPI in Sleeve Gastrectomy</brief_title>
  <official_title>Routine Preoperative PPI in Sleeve Gastrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Minia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Minia University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      he purpose of this study is to study the effect of preoperative PPI in the early outcome of&#xD;
      sleeve gastrectomy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study 200 morbidly obese patients will be included and will be undergone sleeve&#xD;
      gastrectomy. the patients will be randomly assigned into 2 groups, group 1 will be receive&#xD;
      PPI preoperative for 10 day and group 2 will not&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2018</start_date>
  <completion_date type="Actual">August 20, 2018</completion_date>
  <primary_completion_date type="Actual">August 20, 2018</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>early postoperative bleeding and leak</measure>
    <time_frame>2 weeks</time_frame>
    <description>early postoperative complications, including bleeding from stable line either intragastric or intraperitoneal and early leak from stable line</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>operative time</measure>
    <time_frame>5 hours</time_frame>
    <description>time taken from skin incision to closure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>microscopic picture of the removed stomach</measure>
    <time_frame>2 weeks</time_frame>
    <description>histological examination to detect the presence of inflammation in of the removed part of the stomach</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Morbid Obesity</condition>
  <arm_group>
    <arm_group_label>PPI group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>take preoperative PPI for 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>take placebo for for 10 days preoperative</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>sleeve + preoperative PPI</intervention_name>
    <description>sleeve + preoperative PPI</description>
    <arm_group_label>PPI group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>sleeve + preoperative Placebo</intervention_name>
    <description>sleeve + preoperative Placebo</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Morbidly obese patient with BMI more than 40 with or without co-morbidity&#xD;
&#xD;
          -  Morbidly obese patient with BMI more than 35 with co-morbidity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unfit patients for laparoscopic sleeve gastrectomy&#xD;
&#xD;
          -  patients refuse to share in the study&#xD;
&#xD;
          -  patients that already on PPI due to any indications&#xD;
&#xD;
          -  revisional surgery for obesity&#xD;
&#xD;
          -  previous upper abdominal surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of medicine</name>
      <address>
        <city>Minya</city>
        <zip>61511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>September 2, 2018</last_update_submitted>
  <last_update_submitted_qc>September 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Minia University</investigator_affiliation>
    <investigator_full_name>Alaa Mstafa Hassan Sewefy</investigator_full_name>
    <investigator_title>Principal Investigator</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>Undecided</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/NCT03305432
org study id: fac.med.043
nct id: NCT03305432
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
he purpose of this study is to study the effect of preoperative PPI in the early outcome of
      sleeve gastrectomy
In this study 200 morbidly obese patients will be included and will be undergone sleeve
      gastrectomy. the patients will be randomly assigned into 2 groups, group 1 will be receive
      PPI preoperative for 10 day and group 2 will not
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: early postoperative bleeding and leak
time frame: 2 weeks
description: early postoperative complications, including bleeding from stable line either intragastric or intraperitoneal and early leak from stable line
measure: operative time
time frame: 5 hours
description: time taken from skin incision to closure
measure: microscopic picture of the removed stomach
time frame: 2 weeks
description: histological examination to detect the presence of inflammation in of the removed part of the stomach
arm group label: PPI group
arm group type: Experimental
description: take preoperative PPI for 10 days
arm group label: Control group
arm group type: Active Comparator
description: take placebo for for 10 days preoperative
intervention type: Combination Product
intervention name: sleeve + preoperative PPI
description: sleeve + preoperative PPI
arm group label: PPI group
intervention type: Combination Product
intervention name: sleeve + preoperative Placebo
description: sleeve + preoperative Placebo
arm group label: Control group
criteria: 
gender: All
minimum age: 16 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Minia University
investigator full name: Alaa Mstafa Hassan Sewefy
investigator title: Principal Investigator
mesh term: Obesity, Morbid
sharing ipd: Undecided