<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/NCT03796325</url>
  </required_header>
  <id_info>
    <org_study_id>AMC 002-2018</org_study_id>
    <nct_id>NCT03796325</nct_id>
  </id_info>
  <brief_title>Depressive State After Sleeve Gastrectomy</brief_title>
  <official_title>Effect of Laparoscopic Sleeve Gastrectomy in Obese Patients With Depressive State</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assuta Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assuta Medical Center</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>
      Obesity is an epidemic disease that continues to increase causing morbidity and mortality to&#xD;
      those who suffer. Obese patients suffer, frequently, from a depressive state, anger, and&#xD;
      emotional disturbances. It cannot be recognized and depression causes obesity affecting&#xD;
      eating habits or obesity causes depression based on physical, social and occupational&#xD;
      limitations. Many times we see that obese patients are discriminated in every sense of daily&#xD;
      life increasing their depressive state. The best treatment for obesity is bariatric surgery&#xD;
      that causes a sufficient weight loss to correct sleep apnea, diabetes, hypertension, and many&#xD;
      other co-morbidity. The study is based on elucidating the effect of sleeve gastrectomy in&#xD;
      obese patients suffering from depression&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients were classified as suffering from a depressive state before the bariatric&#xD;
      surgery and followed until 3 years after surgery, the data was collected by personal&#xD;
      interview or telephone survey.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">December 22, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Weight loss 3 years after laparoscopic sleeve gastrectomy</measure>
    <time_frame>36 month</time_frame>
    <description>Measure of weight calculating Delta body mass index between preoperative measurement and three years after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression state changes after Sleeve gastrectomy</measure>
    <time_frame>36 month</time_frame>
    <description>Telephonic Questionnaire about feeling satisfaction (Very satisfied, satisfied, indifferent ,unsatisfied), eating mode (Volume-eater, sweet-eater, snack eater, binge eater, healthy-eater), occupations (Unemployed, employed, type of employment).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Obesity, Morbid</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Depression</arm_group_label>
    <description>patients characterize with morbid obesity or obesity type 2 with co-morbidities and depression</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No-depression</arm_group_label>
    <description>patients characterize with morbid obesity or obesity type 2 with co-morbidities without depression</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients 18 years and older with BMI at less 40 or 35-40 with co-morbidities&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: 18 years and older No any type of complication after surgery No&#xD;
        difficult to drink, eat or take medicaments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Any surgical complication Previous gastrointestinal surgery schizofrenia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assuta MC</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Griauzde DH, Ibrahim AM, Fisher N, Stricklen A, Ross R, Ghaferi AA. Understanding the psychosocial impact of weight loss following bariatric surgery: a qualitative study. BMC Obes. 2018 Dec 3;5:38. doi: 10.1186/s40608-018-0215-3. eCollection 2018.</citation>
    <PMID>30524743</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 29, 2018</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>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assuta Medical Center</investigator_affiliation>
    <investigator_full_name>Sergio Gabriel Susmallian</investigator_full_name>
    <investigator_title>Head of the Department of General Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
    <mesh_term>Depression</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/NCT03796325
org study id: AMC 002-2018
nct id: NCT03796325
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Obesity is an epidemic disease that continues to increase causing morbidity and mortality to
      those who suffer. Obese patients suffer, frequently, from a depressive state, anger, and
      emotional disturbances. It cannot be recognized and depression causes obesity affecting
      eating habits or obesity causes depression based on physical, social and occupational
      limitations. Many times we see that obese patients are discriminated in every sense of daily
      life increasing their depressive state. The best treatment for obesity is bariatric surgery
      that causes a sufficient weight loss to correct sleep apnea, diabetes, hypertension, and many
      other co-morbidity. The study is based on elucidating the effect of sleeve gastrectomy in
      obese patients suffering from depression
The patients were classified as suffering from a depressive state before the bariatric
      surgery and followed until 3 years after surgery, the data was collected by personal
      interview or telephone survey.
observational model: Cohort
time perspective: Prospective
measure: Weight loss 3 years after laparoscopic sleeve gastrectomy
time frame: 36 month
description: Measure of weight calculating Delta body mass index between preoperative measurement and three years after surgery
measure: Depression state changes after Sleeve gastrectomy
time frame: 36 month
description: Telephonic Questionnaire about feeling satisfaction (Very satisfied, satisfied, indifferent ,unsatisfied), eating mode (Volume-eater, sweet-eater, snack eater, binge eater, healthy-eater), occupations (Unemployed, employed, type of employment).
arm group label: Depression
description: patients characterize with morbid obesity or obesity type 2 with co-morbidities and depression
arm group label: No-depression
description: patients characterize with morbid obesity or obesity type 2 with co-morbidities without depression
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Israel
citation: Griauzde DH, Ibrahim AM, Fisher N, Stricklen A, Ross R, Ghaferi AA. Understanding the psychosocial impact of weight loss following bariatric surgery: a qualitative study. BMC Obes. 2018 Dec 3;5:38. doi: 10.1186/s40608-018-0215-3. eCollection 2018.
PMID: 30524743
responsible party type: Principal Investigator
investigator affiliation: Assuta Medical Center
investigator full name: Sergio Gabriel Susmallian
investigator title: Head of the Department of General Surgery
mesh term: Obesity, Morbid
mesh term: Depression
sharing ipd: Undecided