<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/NCT03821688</url>
  </required_header>
  <id_info>
    <org_study_id>fac.med.047</org_study_id>
    <nct_id>NCT03821688</nct_id>
  </id_info>
  <brief_title>SAS-J Compared to OAGB and LSG as a Treatment for Morbid Obesity</brief_title>
  <official_title>Single Anastomosis Sleeve Jejunal Bypass Compared to One Anastomosis Gastric Bypass and Sleeve Gastrectomy as a Treatment for Morbid Obesity</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>
      150 morbidly obese patients divided into to equal groups, group A underwent single&#xD;
      anastomosis sleeve jejunal bypass and group B underwent mini gastric bypass, group C&#xD;
      underwent sleeve gastrectomy. All patients were followed for at least one year. all cases&#xD;
      were evaluated as regard BMI, complications, nutritional status and obesity-related&#xD;
      comorbidities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      150 morbidly obese patients divided into to equal groups, group A underwent single&#xD;
      anastomosis sleeve jejunal bypass and group B underwent mini gastric bypass, group C&#xD;
      underwent sleeve gastrectomy. All patients were followed for at least one year. all cases&#xD;
      were evaluated as regard BMI, complications, nutritional status and obesity-related&#xD;
      comorbidities. the minimal follow up period is one year&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2019</start_date>
  <completion_date type="Actual">August 10, 2020</completion_date>
  <primary_completion_date type="Actual">August 10, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>percentage of excess weight loss</measure>
    <time_frame>12 months</time_frame>
    <description>percentage of excess weight loss in kilogram</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the incidence of nutritional deficiency</measure>
    <time_frame>2 years</time_frame>
    <description>the incidence of nutritional deficiency like anemia, hypocalcamia, hypoproteinemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the rate of improved co morbidity</measure>
    <time_frame>2 years</time_frame>
    <description>the effect of the operation on co morbidity like diabetes and hypertension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the incidence of early operative complications</measure>
    <time_frame>one month</time_frame>
    <description>early operative complications like leak, bleeding</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">210</enrollment>
  <condition>Morbid Obesity</condition>
  <arm_group>
    <arm_group_label>SAS-JB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>laparoscopic single anastomosis sleeve jejunal bypass</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MGB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>laparoscopic mini gastric bypass</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LSG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>laparoscopic sleeve gastrectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SAS-JB</intervention_name>
    <description>single anastomosis sleeve jejunal bypass</description>
    <arm_group_label>SAS-JB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>OAGB</intervention_name>
    <description>one anastomosis gastric bypass</description>
    <arm_group_label>MGB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LSG</intervention_name>
    <description>laproscopic sleeve gastrectomy</description>
    <arm_group_label>LSG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  obese patients with BMI more than 40 with or without co-morbidity or more than 35 with&#xD;
             co-morbidity&#xD;
&#xD;
          -  patients fit for laparoscopic surgery&#xD;
&#xD;
          -  give approval to share in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients refused to share in the study&#xD;
&#xD;
          -  patients unfit for surgery&#xD;
&#xD;
          -  patients aged less than 18 and older than 60&#xD;
&#xD;
          -  patient with previous upper abdominal surgery either for obesity or other diseases&#xD;
&#xD;
          -  revisional bariatric procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alaa M Sewefy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Minia University</affiliation>
  </overall_official>
  <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>December 2021</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>January 26, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>December 26, 2021</last_update_submitted>
  <last_update_submitted_qc>December 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</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>Assistant professor</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT03821688
org study id: fac.med.047
nct id: NCT03821688
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
150 morbidly obese patients divided into to equal groups, group A underwent single
      anastomosis sleeve jejunal bypass and group B underwent mini gastric bypass, group C
      underwent sleeve gastrectomy. All patients were followed for at least one year. all cases
      were evaluated as regard BMI, complications, nutritional status and obesity-related
      comorbidities.
150 morbidly obese patients divided into to equal groups, group A underwent single
      anastomosis sleeve jejunal bypass and group B underwent mini gastric bypass, group C
      underwent sleeve gastrectomy. All patients were followed for at least one year. all cases
      were evaluated as regard BMI, complications, nutritional status and obesity-related
      comorbidities. the minimal follow up period is one year
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: percentage of excess weight loss
time frame: 12 months
description: percentage of excess weight loss in kilogram
measure: the incidence of nutritional deficiency
time frame: 2 years
description: the incidence of nutritional deficiency like anemia, hypocalcamia, hypoproteinemia.
measure: the rate of improved co morbidity
time frame: 2 years
description: the effect of the operation on co morbidity like diabetes and hypertension
measure: the incidence of early operative complications
time frame: one month
description: early operative complications like leak, bleeding
arm group label: SAS-JB
arm group type: Experimental
description: laparoscopic single anastomosis sleeve jejunal bypass
arm group label: MGB
arm group type: Active Comparator
description: laparoscopic mini gastric bypass
arm group label: LSG
arm group type: Active Comparator
description: laparoscopic sleeve gastrectomy
intervention type: Procedure
intervention name: SAS-JB
description: single anastomosis sleeve jejunal bypass
arm group label: SAS-JB
intervention type: Procedure
intervention name: OAGB
description: one anastomosis gastric bypass
arm group label: MGB
intervention type: Procedure
intervention name: LSG
description: laproscopic sleeve gastrectomy
arm group label: LSG
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Alaa M Sewefy, MD
role: Principal Investigator
affiliation: Minia University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Minia University
investigator full name: Alaa Mstafa Hassan Sewefy
investigator title: Assistant professor
mesh term: Obesity
mesh term: Obesity, Morbid