<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/NCT04453579</url>
  </required_header>
  <id_info>
    <org_study_id>UNRomeB</org_study_id>
    <nct_id>NCT04453579</nct_id>
  </id_info>
  <brief_title>Bariatric Surgery During Lockdown, Impact of COVID-19 on Physical and Mental Health</brief_title>
  <official_title>Was it Right to Stop Bariatric Surgery During COVID-19 Lockdown?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rome Tor Vergata</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rome Tor Vergata</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>
      From the beginning of March 2020, lockdown regimens prevented patients with obesity from&#xD;
      receiving bariatric surgery. Surgical emergencies and oncological procedures were the only&#xD;
      operations allowed in public hospitals. Consequently, patients with morbid obesity were put&#xD;
      in a stand-by situation. With the aim at exploring physical and psychological conditions of&#xD;
      the investigators future bariatric surgery patients, the investigators built a Questionnaire&#xD;
      concerning obesity and COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: the investigators present an investigation about the impact of COVID-19 on&#xD;
      individuals suffering from severe obesity that were in the waiting list for bariatric&#xD;
      surgery. Worldwide and in Italy bariatric procedures are considered as elective surgery and&#xD;
      therefore were interrupted during the lockdown. The patients are well-known victim of stigma,&#xD;
      social discrimination and the majority of them is affected by maladaptive eating behaviors&#xD;
      that are supposed to worsen due to the isolation, absence of healthcare check-up and alarming&#xD;
      pandemic scenario.the investigators performed telephonic interview providing an ad hoc&#xD;
      questionnaire with the aim to explore their emotional and physical status.&#xD;
&#xD;
      Method: A total of 116 bariatric surgery candidates were approached using a telephonic&#xD;
      interview during the Italian lockdown.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 9, 2020</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">May 4, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Weeks</target_duration>
  <primary_outcome>
    <measure>Psychological conditions</measure>
    <time_frame>2 months</time_frame>
    <description>exploring physical and psychological conditions of our future bariatric surgery patients</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">116</enrollment>
  <condition>Obese</condition>
  <condition>Morbid Obesity</condition>
  <arm_group>
    <arm_group_label>116 patients completed a survey</arm_group_label>
    <description>116 patients were assessed during the Italian lockdown by means of a telephone interview performed by a trained researcher. The interview was composed of socio-demographic items (e.g. employed before and during the lockdown, own accommodation during lockdown etc.) and questions about physical and mental health in relation to the COVID-19 emergency</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephonic interview during the Italian lockdown.</intervention_name>
    <description>The interview was composed of socio-demographic items lockdown, and dichotomous questions about physical and mental health in relation to the COVID-19 emergency</description>
    <arm_group_label>116 patients completed a survey</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        From March 9th to May 4th 2020, 116 bariatric surgery candidates were approached using a&#xD;
        telephonic interview during the Italian lockdown. The interview was composed of&#xD;
        socio-demographic items and dichotomous about physical and mental health in relation to the&#xD;
        COVID-19 emergency.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Severe Obesity with BMI &gt; 35 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alcoholism&#xD;
&#xD;
          -  Drug addiction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>paolo gentileschi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Tor Vergata, Rome, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Michela Campanelli</name>
      <address>
        <city>Rome</city>
        <state>RM</state>
        <zip>00133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.</citation>
    <PMID>32064853</PMID>
  </results_reference>
  <results_reference>
    <citation>Sockalingam S, Leung SE, Cassin SE. The Impact of Coronavirus Disease 2019 on Bariatric Surgery: Redefining Psychosocial Care. Obesity (Silver Spring). 2020 Jun;28(6):1010-1012. doi: 10.1002/oby.22836.</citation>
    <PMID>32294297</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rome Tor Vergata</investigator_affiliation>
    <investigator_full_name>Paolo Gentileschi</investigator_full_name>
    <investigator_title>Head of Bariatric Unit</investigator_title>
  </responsible_party>
  <keyword>Bariatric surgery</keyword>
  <keyword>Covid-19</keyword>
  <keyword>Obesity</keyword>
  <keyword>Mental health</keyword>
  <keyword>Eating disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <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/NCT04453579
org study id: UNRomeB
nct id: NCT04453579
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
From the beginning of March 2020, lockdown regimens prevented patients with obesity from
      receiving bariatric surgery. Surgical emergencies and oncological procedures were the only
      operations allowed in public hospitals. Consequently, patients with morbid obesity were put
      in a stand-by situation. With the aim at exploring physical and psychological conditions of
      the investigators future bariatric surgery patients, the investigators built a Questionnaire
      concerning obesity and COVID-19.
Introduction: the investigators present an investigation about the impact of COVID-19 on
      individuals suffering from severe obesity that were in the waiting list for bariatric
      surgery. Worldwide and in Italy bariatric procedures are considered as elective surgery and
      therefore were interrupted during the lockdown. The patients are well-known victim of stigma,
      social discrimination and the majority of them is affected by maladaptive eating behaviors
      that are supposed to worsen due to the isolation, absence of healthcare check-up and alarming
      pandemic scenario.the investigators performed telephonic interview providing an ad hoc
      questionnaire with the aim to explore their emotional and physical status.

      Method: A total of 116 bariatric surgery candidates were approached using a telephonic
      interview during the Italian lockdown.
observational model: Case-Only
time perspective: Prospective
measure: Psychological conditions
time frame: 2 months
description: exploring physical and psychological conditions of our future bariatric surgery patients
arm group label: 116 patients completed a survey
description: 116 patients were assessed during the Italian lockdown by means of a telephone interview performed by a trained researcher. The interview was composed of socio-demographic items (e.g. employed before and during the lockdown, own accommodation during lockdown etc.) and questions about physical and mental health in relation to the COVID-19 emergency
intervention type: Behavioral
intervention name: Telephonic interview during the Italian lockdown.
description: The interview was composed of socio-demographic items lockdown, and dichotomous questions about physical and mental health in relation to the COVID-19 emergency
arm group label: 116 patients completed a survey
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: paolo gentileschi, MD
role: Principal Investigator
affiliation: University Hospital of Tor Vergata, Rome, Italy
facility: 
country: Italy
citation: Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.
PMID: 32064853
citation: Sockalingam S, Leung SE, Cassin SE. The Impact of Coronavirus Disease 2019 on Bariatric Surgery: Redefining Psychosocial Care. Obesity (Silver Spring). 2020 Jun;28(6):1010-1012. doi: 10.1002/oby.22836.
PMID: 32294297
responsible party type: Principal Investigator
investigator affiliation: University of Rome Tor Vergata
investigator full name: Paolo Gentileschi
investigator title: Head of Bariatric Unit
mesh term: COVID-19
mesh term: Obesity, Morbid
sharing ipd: Undecided