<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/NCT04480034</url>
  </required_header>
  <id_info>
    <org_study_id>008758/27.05.2020</org_study_id>
    <nct_id>NCT04480034</nct_id>
  </id_info>
  <brief_title>Obesity Surgery During 2020 Italian Pandemic</brief_title>
  <official_title>Laparoscopic Bariatric Surgery During Phase 2-3 Covid-19 Pandemic in Italy: a Multicenter, Prospective, Observational Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Azienda Ospedaliero, Universitaria Pisana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Azienda Ospedaliera di Padova</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IRCCS Azienda Ospedaliero-Universitaria di Bologna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IRCCS Policlinico S. Donato</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Rome Tor Vergata</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Azienda Ospedaliera Città della Salute e della Scienza di Torino</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Humanitas Clinical and Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Roma La Sapienza</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The first person-to-person Coronavirus disease (COVID-19) transmission in Italy was reported&#xD;
      on Feb 21st, 2020, causing one of the most massive outbreak in Europe so far that stopped&#xD;
      immediately all elective surgical procedures. Bariatric surgery represents the most effective&#xD;
      treatment to obtain an important, long-term weight loss and comorbidities' resolution,&#xD;
      including respiratory disorders. A sensitive decrease of epidemic has been observed lately&#xD;
      and a gradual and progressive stop of the lockdown (phase 2-3) was planned, when the virus is&#xD;
      supposed to be under control and protocols are guiding the restart of the elective bariatric&#xD;
      surgery. Several questions are currently open: Laparoscopic bariatric surgery is safe in the&#xD;
      phase 2-3? What's the expected complications rate? The actual hospital protocols are&#xD;
      effective to minimize the risk of postoperative COVID-19 infection? Aim: to analyse results&#xD;
      of bariatric surgery during phase 2-3 COVID-19 pandemic in Italy. Primary end point: 30 days&#xD;
      COVID-19 infection, mortality and complications. Secondary end points: readmission rate 30&#xD;
      days, reoperations for any reason related to surgery. Study design: prospective multicenter&#xD;
      observational. Setting: Italian National Health Service 8 high-volume bariatric centres.&#xD;
      Enrollment criteria: No previous Covid-19 infection; Primary, standard IFSO approved&#xD;
      bariatric procedures; No concomitant procedure; No previous major abdominal surgery; &gt;18&lt;60&#xD;
      years old; Compensated comorbidities; Official SICOB's surgical informed consent given,&#xD;
      including COVID-19 addendum; Adherence to very restrictive protocols regarding: hospital&#xD;
      admission, management of in-hospital patients and after discharge. Follow-up: scheduled&#xD;
      outpatient visit 30th postoperative day. Data evaluation: all the cases performed during&#xD;
      July/December 2020 will be collected in a prospective database. Patients operated during the&#xD;
      period July/December 2019 in the same centers will be considered comparative group (control).&#xD;
      Expected results: Transparent information to the patients, and the introduction of the&#xD;
      COVID-19 protocol concerning patients and health-professionals protection, should guarantee a&#xD;
      safe restart of bariatric surgery in Italy. The network of 8 high-volume centers sharing&#xD;
      information and protocols in this &quot;unexplored&quot; period will be a guarantee for patients'&#xD;
      safety. Bariatric surgery should induce a postoperative amelioration of the comorbidities&#xD;
      reducing the risks in case of a second outbreak.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe&#xD;
      acute respiratory syndrome coronavirus 2 (SARS-CoV-2) . The disease was first identified in&#xD;
      December 2019 in Wuhan, the capital of China's Hubei province, and has since spread globally,&#xD;
      resulting in the ongoing 2019-20 coronavirus pandemic . As of 08.05.2020, more than 3.91&#xD;
      million cases have been reported across 185 countries and territories, resulting in more than&#xD;
      218,000 deaths. More than 1.344.000 people have recovered . Even though there are very few&#xD;
      available data on BMI for patients with COVID-19 infections, the role of obesity in the&#xD;
      COVID-19 epidemic must not be ignored. A recent study on patients admitted in China for&#xD;
      pneumonia from SARS-CoV-2, showed that obesity is associated with higher risks to develop&#xD;
      severe pneumonia, especially in men . Obesity plays an important role in the pathogenesis of&#xD;
      COVID-19 infection . In fact, the immune system, which is a key player in the pathogenesis of&#xD;
      COVID-19, also plays an important role in obesity-induced adipose tissue inflammation. This&#xD;
      inflammation of adipose tissue results in metabolic dysfunction potentially leading to&#xD;
      dyslipidaemia, insulin resistance, type 2 diabetes mellitus, hypertension, and cardiovascular&#xD;
      disease. A systematic review and meta-analysis demonstrated that severe obesity (body mass&#xD;
      index BMI ≥ 40 kg/m2) represents a major risk factor of intensive care unit admission or&#xD;
      death in individuals affected by H1N1 influenza . Thereafter, obesity is associated with a&#xD;
      higher risk of infectious diseases, in particular of the respiratory tract.&#xD;
&#xD;
      There are a number of factors predisposing subjects with obesity to viral infections. These&#xD;
      factors include low-grade chronic inflammation with hyper-production of pro-inflammatory&#xD;
      cytokines, reduced natural killer (NK) cell number and activity, altered CD4:CD8T cell&#xD;
      balance, impaired response to antigen stimulation and high expression of adipocyte&#xD;
      angiotensin type 1 and 2 receptors.&#xD;
&#xD;
      Furthermore, obesity is associated with, and responsible for, comorbidity conditions that may&#xD;
      represent risk factors for serious COVID-19 infection (i.e. type II diabetes, ischemic&#xD;
      cardiac disease, etc.). Extra attention and precautions for patients with obesity during this&#xD;
      epidemic is recommended. Whenever COVID-19 infection is suspected, screening must be&#xD;
      systematic, particularly if the patient has obesity.&#xD;
&#xD;
      So far, bariatric surgery represents the most effective treatment to obtain a long-term&#xD;
      meaningful weight reduction and resolution of comorbidities including respiratory disorders.&#xD;
      In a very large case series study including 56277 subjects who underwent bariatric surgery in&#xD;
      the United States, the overall risk of developing common infectious diseases including&#xD;
      respiratory infections decreased significantly in men during the first two years after&#xD;
      surgery (aOR, 0.69 [95% CI, 0.60-0.79]; P&lt;0.001).&#xD;
&#xD;
      The first person-to-person transmission in Italy was reported on February 21st, 2020, in&#xD;
      Lombardy region, the most crowded and rich region in Italy, causing the most massive Covid-19&#xD;
      outbreak in Europe so far. First positive cases of Sars-Co-v-2 were registered in Italy by&#xD;
      29th of January 2020. The COVID-19 outbreak stopped all elective surgical procedures by 9th&#xD;
      of March, including bariatric/metabolic surgery except emergency conditions as suggested by&#xD;
      recent IFSO recommendations . All elective surgical and endoscopic cases for metabolic and&#xD;
      bariatric surgery should be postponed during the phase one outbreak. This would minimize&#xD;
      risks to both patient and healthcare team, as well as reducing the utilization of unnecessary&#xD;
      resources, such as beds, ventilators and personal protective equipment (PPE). In addition,&#xD;
      postponing these services will minimize potential exposure of the COVID-19 virus to&#xD;
      unsuspecting healthcare providers and patients.&#xD;
&#xD;
      To understand what could have been the impact of operating a population at risk of infection&#xD;
      without specific precautions, we gathered a group of eight high-volume Italian bariatric&#xD;
      centers, which performed 840 laparoscopic bariatric procedures during January and February&#xD;
      2020. Five are located in regions with high infection rates (Lombardy, Veneto, Piedmont,&#xD;
      Emilia Romagna), and 3 are in areas with infection rate close to the Italian average&#xD;
      (Tuscany, Lazio). A structured phone interview was administered to all patients operated&#xD;
      during that period. We found five infections (5.9 cases out of 1000 inhabitants), four in&#xD;
      Lombardy, and one in Veneto. The overall rate of infection on May 2, 2020, was similar in the&#xD;
      2 regions, 7.19 out of 1.000 inhabitants . Among infected patients, 2 had mild symptoms and&#xD;
      home care, and three were hospitalized for fever and dyspnea; none died. Four out of five&#xD;
      cases were over 60 years, all were female, and 3 out of 5 cases, reported an extra-hospital&#xD;
      contact with positive COVID-19 people. All 5 cases healed eventually, with a negative swab.&#xD;
&#xD;
      During the last days of April 2020, a sensitive decrease of epidemic has been observed in&#xD;
      Italy and Government planned a gradual and progressive stop of the lockdown (the so-called&#xD;
      phase 2). That means the start of a new period when the virus is supposed to be under control&#xD;
      and protocol are coming in the National Health Care System (SSN) to restart the elective&#xD;
      surgical practice.&#xD;
&#xD;
      Several open questions are currently waiting the answers useful for the settlement of the&#xD;
      management of obese patients, considering bariatric surgery effective for weight loss and&#xD;
      co-morbidity control as well protective against eventual recurrent outbreak.&#xD;
&#xD;
        -  Laparoscopic bariatric surgery is safe in the phase 2 outbreak?&#xD;
&#xD;
        -  What's the expected complication rate of laparoscopic bariatric surgery in COVID-19&#xD;
           phase 2?&#xD;
&#xD;
        -  The hospital protocols are effective to minimize the risk of postoperative Covid 19&#xD;
           infection after elective bariatric surgery in selected patients? Aim: to analyze results&#xD;
           of laparoscopic bariatric surgery during phase 2 COVID-19 pandemic in Italy.&#xD;
&#xD;
      Primary end point: 30 days COVID-19 infection, mortality and complications. Secondary end&#xD;
      points: readmission rate 30 days, reoperations for any reason related to bariatric surgery.&#xD;
&#xD;
      Study design: prospective multicenter observational Time interval: 12 months (July 2020 - May&#xD;
      2021): recruitment and therapy July 2020-December 2020, follow-up January 2021, data&#xD;
      collection and analysis, manuscript preparation and publication Feb-May 2021).&#xD;
&#xD;
      Setting: Italian National Health Service' high-volume bariatric centres, academic hospitals.&#xD;
&#xD;
      Hospital admission protocol&#xD;
&#xD;
        1. Two to three days before admission, a doctor must interview the patient by telephone&#xD;
           with the following questionnaire:&#xD;
&#xD;
             -  Did you have fever (threshold value &gt; 37.5ºC / 99.5ºF), especially in the last 48&#xD;
                hours?&#xD;
&#xD;
             -  Do you have any new respiratory symptoms, especially when you walk?&#xD;
&#xD;
             -  Do you have other symptoms: vomiting, diarrhea, conjunctivitis, changes in smell,&#xD;
                or taste, osteoarticular pain, excessive fatigue?&#xD;
&#xD;
             -  Have you had contact in the last two weeks with a confirmed case (clinical&#xD;
                diagnosis - positive swab) of COVID-19?&#xD;
&#xD;
        2. 24-48 hours before hospitalization, the patient must arrive at the hospital: outside the&#xD;
           hospital, the medical staff must repeat the interview as above and must swab the&#xD;
           patient. In the case of a positive swab, surgery must be suspended. In the case of&#xD;
           negativity, the patient must receive and sign a specific COVID-19 consent, and the&#xD;
           operation can be carried out, with hospitalization on the same day of the procedure.&#xD;
&#xD;
      These procedures are in line with international and national guidelines for the screening of&#xD;
      patients before entry the hospital (12) Screening at admission&#xD;
&#xD;
        1. Standard interview (National accepted Covid-19 questionnaire, see attachment 1)&#xD;
&#xD;
        2. Fever check&#xD;
&#xD;
        3. Chest X-ray / Thoracic CT scan Surgical informed consent&#xD;
&#xD;
      1. SICOB approved informed consent for standard bariatric procedures (2014 version); 2. A&#xD;
      modified informed consent including the risk of COVID-1919 infection, will be adopted and&#xD;
      added by all centers to the standard, above listed official consent: &quot;I am aware that this&#xD;
      bariatric procedure may lead to an increase in the possibility of contracting the COVID-19&#xD;
      infection, due to the general situation currently present, with a possible further increase&#xD;
      in postoperative complications. I am also aware that, following the intervention, I will have&#xD;
      to undergo a 14-day postoperative quarantine period, I will have to measure the temperature&#xD;
      twice a day, I will be prohibited from traveling and traveling. The first postoperative&#xD;
      check-up will be performed at the end of this period, unless complications related to surgery&#xD;
      arise.&quot; Operating Room (OR) protocol&#xD;
&#xD;
        -  For surgeon standard personal protective equipment (PPE) plus N95 mask&#xD;
&#xD;
        -  For anesthesiologists and nurses who manage the airways and gastric bougie positioning,&#xD;
           we recommend using N99 mask, face shield, single-use waterproof gown, and double gloves&#xD;
&#xD;
        -  At the end of each procedure, every PPE must be changed&#xD;
&#xD;
        -  Restrict access to people in OR&#xD;
&#xD;
        -  Expert surgeons and anesthesiologists must perform the procedures to minimize the OR&#xD;
           occupation time.&#xD;
&#xD;
        -  A smoke evacuator system should be employed to avoid aerosol contamination; in the&#xD;
           alternative, a filter must be connected to the exsufflation system.&#xD;
&#xD;
        -  A negative pressure in the OR is not mandatory, but it is crucial to allow enough time&#xD;
           between cases for complete room air exchange. In case the OR had been used for intensive&#xD;
           care during phase 1 pandemic, proper sanitization is required.&#xD;
&#xD;
      Management of in-hospital patients&#xD;
&#xD;
        -  No Covid-19 hospital/section should be used for elective bariatric surgery.&#xD;
&#xD;
        -  Standard PPE for staff is mandatory.&#xD;
&#xD;
        -  Social distance must be respected even in case of post-surgical mobilization; patients&#xD;
           should always wear a surgical mask.&#xD;
&#xD;
        -  Each patient should have a single room, or in the case of a large room, he must be&#xD;
           assigned a suitable space to comply with the laws in force on social distancing.&#xD;
&#xD;
        -  ERAS protocol is welcomed whenever is possible.&#xD;
&#xD;
      After discharge:&#xD;
&#xD;
        -  In case of intra-hospital contact with Covid-19 patient or healthcare professional, 14&#xD;
           days self-quarantine after discharge is mandatory&#xD;
&#xD;
        -  Home physical activity (same proposed program for all groups)&#xD;
&#xD;
        -  Implement Oral supplementation (proposed recommendation for all groups)&#xD;
&#xD;
        -  Low dose heparin for at least three weeks (proposed treatment for all groups)&#xD;
&#xD;
        -  After 7 and 15 days the patients receive a follow-up phone with specific questions about&#xD;
           Covid-19 (attached structured phone interview) Follow-up: Scheduled outpatient visit: 30&#xD;
           postoperative day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Anticipated">May 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2021</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Postoperative COVID-19 infection</measure>
    <time_frame>30 postoperative days</time_frame>
    <description>Postbariatric surgery COVID-19 infection, mortality and complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications related to bariatric surgery</measure>
    <time_frame>30 postoperative days</time_frame>
    <description>Complications, reoperations for any reason related to bariatric surgery.</description>
  </secondary_outcome>
  <number_of_groups>8</number_of_groups>
  <enrollment type="Anticipated">1600</enrollment>
  <condition>Bariatric Surgery Candidate</condition>
  <condition>Covid19</condition>
  <condition>Complication of Surgical Procedure</condition>
  <condition>Pneumonia, Viral</condition>
  <condition>Viral Infection</condition>
  <condition>Obesity, Morbid</condition>
  <condition>Safety Issues</condition>
  <condition>Readmission</condition>
  <arm_group>
    <arm_group_label>Group Pisa</arm_group_label>
    <description>All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UOC Chirurgia Bariatrica, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy (Head Prof. Marco Anselmino) will be collected in a prospective database, to monitor the postoperative course.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Padova</arm_group_label>
    <description>All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UOSD Week Surgery, Azienda Ospedaliera, Università di Padova, Italy (Head Dr. Mirto Foletto) will be collected in a prospective database, to monitor the postoperative course.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Bologna</arm_group_label>
    <description>All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit Chirurgia Bariatrica, Azienda Ospedaliera Universitaria di Bologna, Italy (Head Dr. Paolo Bernante) will be collected in a prospective database, to monitor the postoperative course.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Bergamo</arm_group_label>
    <description>All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UOC Chirurgia Generale e Oncologica, Policlinico San Marco di Zingonia, Bergamo, Italy (Head Prof. Stefano Olmi) will be collected in a prospective database, to monitor the postoperative course.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Tor Vergata</arm_group_label>
    <description>All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit U.O.S.D. Chirurgia Mininvasiva e dell'Apparato Digerente, Università Tor Vergata, Rome, Italy (Head Prof. Paolo Gentileschi) will be collected in a prospective database, to monitor the postoperative course.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Torino</arm_group_label>
    <description>All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit Dipartimento di Scienze Chirurgiche, Azienda Ospedaliera Universitaria Citta della Salute e della Scienza, Università di Torino, Italy (Head Prof. Mario Morino) will be collected in a prospective database, to monitor the postoperative course.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Milano</arm_group_label>
    <description>All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UO di Chirurgia Bariatrica, Humanitas Research Hospital, Rozzano, Milano, Italy (Head Dr. Giuseppe Marinari) will be collected in a prospective database, to monitor the postoperative course.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Rome</arm_group_label>
    <description>All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UOC Chirurgia Generale &amp; Bariatric Center of Excellence IFSO-EC, University La Sapienza of Rome, Italy (Head Prof. Gianfranco Silecchia) will be collected in a prospective database, to monitor the postoperative course.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bariatric procedures</intervention_name>
    <description>All standard, laparoscopic bariatric procedures endorsed by SICOB (Società Italiana della Chirurgia dell'Obesità, Italian Society of Obesity Surgery) and by IFSO (International Federation of the Societies of Obesity Surgery), will be considered: sleeve gastrectomy, R-en-Y gastric bypass, one anastomosis gastric bypass, single anastomosis duodeno-ileal bypass with sleeve. The selection criteria for the surgery candidates will comply to the latest guidelines for bariatric surgery endorsed by SICOB, IFSO and EAES (European Association of Endoscopic Surgery). All the participating centers will follow the usual recruitment protocol. Restart of the bariatric elective surgery is based on the guidelines of SICOB for the bariatric surgery restart in Italy during the COVID-19 phase 2-3 of endemics.</description>
    <arm_group_label>Group Bergamo</arm_group_label>
    <arm_group_label>Group Bologna</arm_group_label>
    <arm_group_label>Group Milano</arm_group_label>
    <arm_group_label>Group Padova</arm_group_label>
    <arm_group_label>Group Pisa</arm_group_label>
    <arm_group_label>Group Rome</arm_group_label>
    <arm_group_label>Group Tor Vergata</arm_group_label>
    <arm_group_label>Group Torino</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Since July 2020, all the bariatric cases performed in the 8 participating centers will be&#xD;
        collected in a prospective database, to monitor the postoperative course of the patients&#xD;
        until WHO will declare the end of the pandemic, in order to determine the incidence of&#xD;
        Sars-Cov-2 infection after bariatric surgery.&#xD;
&#xD;
        All the data will be collected anonymously on a database by an independent data manager.&#xD;
        The results will be evaluated in January 2021. As comparative group will be considered the&#xD;
        patients operated during the period July/December 2019 in the same centers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Primary bariatric surgery;&#xD;
&#xD;
          2. Compensated DMT2;&#xD;
&#xD;
          3. Controlled hypertension;&#xD;
&#xD;
          4. Patients with OSAS can only be admitted if therapy with home CPAP is effective&#xD;
&#xD;
          5. Laparoscopic standard bariatric procedure;&#xD;
&#xD;
          6. Procedure duration less than 120 minutes;&#xD;
&#xD;
          7. Official SICOB's surgical informed consent given, including Covid-19 addendum.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous Covid-19 infection;&#xD;
&#xD;
          -  patients who may need an extended stay or intensive care (BMI &gt; 60).&#xD;
&#xD;
          -  concomitant procedure;&#xD;
&#xD;
          -  previous major abdominal surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Gianfranco Silecchia, Prof</last_name>
    <phone>003907736513304</phone>
    <email>gianfranco.silecchia@uniroma1.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cristian E Boru, Dr</last_name>
    <phone>003907736513304</phone>
    <email>drcrisb@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University La Sapienza of Rome, Department of Medico-Surgical Sciences and Biotechnologies</name>
      <address>
        <city>Latina</city>
        <state>LT</state>
        <zip>04100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alessandra Papa</last_name>
      <phone>003907731757245</phone>
      <email>alessandra.papa@uniroma1.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Hui DS, I Azhar E, Madani TA, Ntoumi F, Kock R, Dar O, Ippolito G, Mchugh TD, Memish ZA, Drosten C, Zumla A, Petersen E. The continuing 2019-nCoV epidemic threat of novel coronaviruses to global health - The latest 2019 novel coronavirus outbreak in Wuhan, China. Int J Infect Dis. 2020 Feb;91:264-266. doi: 10.1016/j.ijid.2020.01.009. Epub 2020 Jan 14. No abstract available.</citation>
    <PMID>31953166</PMID>
  </results_reference>
  <results_reference>
    <citation>Chen Q, Zheng Z, Zhang C, Zhang X, Wu H, Wang J, Wang S, Zheng C. Clinical characteristics of 145 patients with corona virus disease 2019 (COVID-19) in Taizhou, Zhejiang, China. Infection. 2020 Aug;48(4):543-551. doi: 10.1007/s15010-020-01432-5. Epub 2020 Apr 28.</citation>
    <PMID>32342479</PMID>
  </results_reference>
  <results_reference>
    <citation>Kassir R. Risk of COVID-19 for patients with obesity. Obes Rev. 2020 Jun;21(6):e13034. doi: 10.1111/obr.13034. Epub 2020 Apr 13. No abstract available.</citation>
    <PMID>32281287</PMID>
  </results_reference>
  <results_reference>
    <citation>Honce R, Schultz-Cherry S. Impact of Obesity on Influenza A Virus Pathogenesis, Immune Response, and Evolution. Front Immunol. 2019 May 10;10:1071. doi: 10.3389/fimmu.2019.01071. eCollection 2019.</citation>
    <PMID>31134099</PMID>
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  <results_reference>
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  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>November 4, 2020</last_update_submitted>
  <last_update_submitted_qc>November 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Gianfranco Silecchia</investigator_full_name>
    <investigator_title>MD, PhD, Full Professor of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Pneumonia, Viral</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All the data will be collected anonymously on a database by an independent data manager. All participants will have access to all recorded data through independent web access.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>12 months</ipd_time_frame>
    <ipd_access_criteria>restricted access, based on username and password dedicated for every group</ipd_access_criteria>
    <ipd_url>https://test-chirurgiabariatricadurantecovid.pantheonsite.io/</ipd_url>
  </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/NCT04480034
org study id: 008758/27.05.2020
nct id: NCT04480034
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The first person-to-person Coronavirus disease (COVID-19) transmission in Italy was reported
      on Feb 21st, 2020, causing one of the most massive outbreak in Europe so far that stopped
      immediately all elective surgical procedures. Bariatric surgery represents the most effective
      treatment to obtain an important, long-term weight loss and comorbidities' resolution,
      including respiratory disorders. A sensitive decrease of epidemic has been observed lately
      and a gradual and progressive stop of the lockdown (phase 2-3) was planned, when the virus is
      supposed to be under control and protocols are guiding the restart of the elective bariatric
      surgery. Several questions are currently open: Laparoscopic bariatric surgery is safe in the
      phase 2-3? What's the expected complications rate? The actual hospital protocols are
      effective to minimize the risk of postoperative COVID-19 infection? Aim: to analyse results
      of bariatric surgery during phase 2-3 COVID-19 pandemic in Italy. Primary end point: 30 days
      COVID-19 infection, mortality and complications. Secondary end points: readmission rate 30
      days, reoperations for any reason related to surgery. Study design: prospective multicenter
      observational. Setting: Italian National Health Service 8 high-volume bariatric centres.
      Enrollment criteria: No previous Covid-19 infection; Primary, standard IFSO approved
      bariatric procedures; No concomitant procedure; No previous major abdominal surgery; >18<60
      years old; Compensated comorbidities; Official SICOB's surgical informed consent given,
      including COVID-19 addendum; Adherence to very restrictive protocols regarding: hospital
      admission, management of in-hospital patients and after discharge. Follow-up: scheduled
      outpatient visit 30th postoperative day. Data evaluation: all the cases performed during
      July/December 2020 will be collected in a prospective database. Patients operated during the
      period July/December 2019 in the same centers will be considered comparative group (control).
      Expected results: Transparent information to the patients, and the introduction of the
      COVID-19 protocol concerning patients and health-professionals protection, should guarantee a
      safe restart of bariatric surgery in Italy. The network of 8 high-volume centers sharing
      information and protocols in this "unexplored" period will be a guarantee for patients'
      safety. Bariatric surgery should induce a postoperative amelioration of the comorbidities
      reducing the risks in case of a second outbreak.
Background Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe
      acute respiratory syndrome coronavirus 2 (SARS-CoV-2) . The disease was first identified in
      December 2019 in Wuhan, the capital of China's Hubei province, and has since spread globally,
      resulting in the ongoing 2019-20 coronavirus pandemic . As of 08.05.2020, more than 3.91
      million cases have been reported across 185 countries and territories, resulting in more than
      218,000 deaths. More than 1.344.000 people have recovered . Even though there are very few
      available data on BMI for patients with COVID-19 infections, the role of obesity in the
      COVID-19 epidemic must not be ignored. A recent study on patients admitted in China for
      pneumonia from SARS-CoV-2, showed that obesity is associated with higher risks to develop
      severe pneumonia, especially in men . Obesity plays an important role in the pathogenesis of
      COVID-19 infection . In fact, the immune system, which is a key player in the pathogenesis of
      COVID-19, also plays an important role in obesity-induced adipose tissue inflammation. This
      inflammation of adipose tissue results in metabolic dysfunction potentially leading to
      dyslipidaemia, insulin resistance, type 2 diabetes mellitus, hypertension, and cardiovascular
      disease. A systematic review and meta-analysis demonstrated that severe obesity (body mass
      index BMI ≥ 40 kg/m2) represents a major risk factor of intensive care unit admission or
      death in individuals affected by H1N1 influenza . Thereafter, obesity is associated with a
      higher risk of infectious diseases, in particular of the respiratory tract.

      There are a number of factors predisposing subjects with obesity to viral infections. These
      factors include low-grade chronic inflammation with hyper-production of pro-inflammatory
      cytokines, reduced natural killer (NK) cell number and activity, altered CD4:CD8T cell
      balance, impaired response to antigen stimulation and high expression of adipocyte
      angiotensin type 1 and 2 receptors.

      Furthermore, obesity is associated with, and responsible for, comorbidity conditions that may
      represent risk factors for serious COVID-19 infection (i.e. type II diabetes, ischemic
      cardiac disease, etc.). Extra attention and precautions for patients with obesity during this
      epidemic is recommended. Whenever COVID-19 infection is suspected, screening must be
      systematic, particularly if the patient has obesity.

      So far, bariatric surgery represents the most effective treatment to obtain a long-term
      meaningful weight reduction and resolution of comorbidities including respiratory disorders.
      In a very large case series study including 56277 subjects who underwent bariatric surgery in
      the United States, the overall risk of developing common infectious diseases including
      respiratory infections decreased significantly in men during the first two years after
      surgery (aOR, 0.69 [95% CI, 0.60-0.79]; P<0.001).

      The first person-to-person transmission in Italy was reported on February 21st, 2020, in
      Lombardy region, the most crowded and rich region in Italy, causing the most massive Covid-19
      outbreak in Europe so far. First positive cases of Sars-Co-v-2 were registered in Italy by
      29th of January 2020. The COVID-19 outbreak stopped all elective surgical procedures by 9th
      of March, including bariatric/metabolic surgery except emergency conditions as suggested by
      recent IFSO recommendations . All elective surgical and endoscopic cases for metabolic and
      bariatric surgery should be postponed during the phase one outbreak. This would minimize
      risks to both patient and healthcare team, as well as reducing the utilization of unnecessary
      resources, such as beds, ventilators and personal protective equipment (PPE). In addition,
      postponing these services will minimize potential exposure of the COVID-19 virus to
      unsuspecting healthcare providers and patients.

      To understand what could have been the impact of operating a population at risk of infection
      without specific precautions, we gathered a group of eight high-volume Italian bariatric
      centers, which performed 840 laparoscopic bariatric procedures during January and February
      2020. Five are located in regions with high infection rates (Lombardy, Veneto, Piedmont,
      Emilia Romagna), and 3 are in areas with infection rate close to the Italian average
      (Tuscany, Lazio). A structured phone interview was administered to all patients operated
      during that period. We found five infections (5.9 cases out of 1000 inhabitants), four in
      Lombardy, and one in Veneto. The overall rate of infection on May 2, 2020, was similar in the
      2 regions, 7.19 out of 1.000 inhabitants . Among infected patients, 2 had mild symptoms and
      home care, and three were hospitalized for fever and dyspnea; none died. Four out of five
      cases were over 60 years, all were female, and 3 out of 5 cases, reported an extra-hospital
      contact with positive COVID-19 people. All 5 cases healed eventually, with a negative swab.

      During the last days of April 2020, a sensitive decrease of epidemic has been observed in
      Italy and Government planned a gradual and progressive stop of the lockdown (the so-called
      phase 2). That means the start of a new period when the virus is supposed to be under control
      and protocol are coming in the National Health Care System (SSN) to restart the elective
      surgical practice.

      Several open questions are currently waiting the answers useful for the settlement of the
      management of obese patients, considering bariatric surgery effective for weight loss and
      co-morbidity control as well protective against eventual recurrent outbreak.

        -  Laparoscopic bariatric surgery is safe in the phase 2 outbreak?

        -  What's the expected complication rate of laparoscopic bariatric surgery in COVID-19
           phase 2?

        -  The hospital protocols are effective to minimize the risk of postoperative Covid 19
           infection after elective bariatric surgery in selected patients? Aim: to analyze results
           of laparoscopic bariatric surgery during phase 2 COVID-19 pandemic in Italy.

      Primary end point: 30 days COVID-19 infection, mortality and complications. Secondary end
      points: readmission rate 30 days, reoperations for any reason related to bariatric surgery.

      Study design: prospective multicenter observational Time interval: 12 months (July 2020 - May
      2021): recruitment and therapy July 2020-December 2020, follow-up January 2021, data
      collection and analysis, manuscript preparation and publication Feb-May 2021).

      Setting: Italian National Health Service' high-volume bariatric centres, academic hospitals.

      Hospital admission protocol

        1. Two to three days before admission, a doctor must interview the patient by telephone
           with the following questionnaire:

             -  Did you have fever (threshold value > 37.5ºC / 99.5ºF), especially in the last 48
                hours?

             -  Do you have any new respiratory symptoms, especially when you walk?

             -  Do you have other symptoms: vomiting, diarrhea, conjunctivitis, changes in smell,
                or taste, osteoarticular pain, excessive fatigue?

             -  Have you had contact in the last two weeks with a confirmed case (clinical
                diagnosis - positive swab) of COVID-19?

        2. 24-48 hours before hospitalization, the patient must arrive at the hospital: outside the
           hospital, the medical staff must repeat the interview as above and must swab the
           patient. In the case of a positive swab, surgery must be suspended. In the case of
           negativity, the patient must receive and sign a specific COVID-19 consent, and the
           operation can be carried out, with hospitalization on the same day of the procedure.

      These procedures are in line with international and national guidelines for the screening of
      patients before entry the hospital (12) Screening at admission

        1. Standard interview (National accepted Covid-19 questionnaire, see attachment 1)

        2. Fever check

        3. Chest X-ray / Thoracic CT scan Surgical informed consent

      1. SICOB approved informed consent for standard bariatric procedures (2014 version); 2. A
      modified informed consent including the risk of COVID-1919 infection, will be adopted and
      added by all centers to the standard, above listed official consent: "I am aware that this
      bariatric procedure may lead to an increase in the possibility of contracting the COVID-19
      infection, due to the general situation currently present, with a possible further increase
      in postoperative complications. I am also aware that, following the intervention, I will have
      to undergo a 14-day postoperative quarantine period, I will have to measure the temperature
      twice a day, I will be prohibited from traveling and traveling. The first postoperative
      check-up will be performed at the end of this period, unless complications related to surgery
      arise." Operating Room (OR) protocol

        -  For surgeon standard personal protective equipment (PPE) plus N95 mask

        -  For anesthesiologists and nurses who manage the airways and gastric bougie positioning,
           we recommend using N99 mask, face shield, single-use waterproof gown, and double gloves

        -  At the end of each procedure, every PPE must be changed

        -  Restrict access to people in OR

        -  Expert surgeons and anesthesiologists must perform the procedures to minimize the OR
           occupation time.

        -  A smoke evacuator system should be employed to avoid aerosol contamination; in the
           alternative, a filter must be connected to the exsufflation system.

        -  A negative pressure in the OR is not mandatory, but it is crucial to allow enough time
           between cases for complete room air exchange. In case the OR had been used for intensive
           care during phase 1 pandemic, proper sanitization is required.

      Management of in-hospital patients

        -  No Covid-19 hospital/section should be used for elective bariatric surgery.

        -  Standard PPE for staff is mandatory.

        -  Social distance must be respected even in case of post-surgical mobilization; patients
           should always wear a surgical mask.

        -  Each patient should have a single room, or in the case of a large room, he must be
           assigned a suitable space to comply with the laws in force on social distancing.

        -  ERAS protocol is welcomed whenever is possible.

      After discharge:

        -  In case of intra-hospital contact with Covid-19 patient or healthcare professional, 14
           days self-quarantine after discharge is mandatory

        -  Home physical activity (same proposed program for all groups)

        -  Implement Oral supplementation (proposed recommendation for all groups)

        -  Low dose heparin for at least three weeks (proposed treatment for all groups)

        -  After 7 and 15 days the patients receive a follow-up phone with specific questions about
           Covid-19 (attached structured phone interview) Follow-up: Scheduled outpatient visit: 30
           postoperative day.
observational model: Cohort
time perspective: Prospective
measure: Postoperative COVID-19 infection
time frame: 30 postoperative days
description: Postbariatric surgery COVID-19 infection, mortality and complications
measure: Complications related to bariatric surgery
time frame: 30 postoperative days
description: Complications, reoperations for any reason related to bariatric surgery.
arm group label: Group Pisa
description: All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UOC Chirurgia Bariatrica, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy (Head Prof. Marco Anselmino) will be collected in a prospective database, to monitor the postoperative course.
arm group label: Group Padova
description: All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UOSD Week Surgery, Azienda Ospedaliera, Università di Padova, Italy (Head Dr. Mirto Foletto) will be collected in a prospective database, to monitor the postoperative course.
arm group label: Group Bologna
description: All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit Chirurgia Bariatrica, Azienda Ospedaliera Universitaria di Bologna, Italy (Head Dr. Paolo Bernante) will be collected in a prospective database, to monitor the postoperative course.
arm group label: Group Bergamo
description: All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UOC Chirurgia Generale e Oncologica, Policlinico San Marco di Zingonia, Bergamo, Italy (Head Prof. Stefano Olmi) will be collected in a prospective database, to monitor the postoperative course.
arm group label: Group Tor Vergata
description: All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit U.O.S.D. Chirurgia Mininvasiva e dell'Apparato Digerente, Università Tor Vergata, Rome, Italy (Head Prof. Paolo Gentileschi) will be collected in a prospective database, to monitor the postoperative course.
arm group label: Group Torino
description: All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit Dipartimento di Scienze Chirurgiche, Azienda Ospedaliera Universitaria Citta della Salute e della Scienza, Università di Torino, Italy (Head Prof. Mario Morino) will be collected in a prospective database, to monitor the postoperative course.
arm group label: Group Milano
description: All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UO di Chirurgia Bariatrica, Humanitas Research Hospital, Rozzano, Milano, Italy (Head Dr. Giuseppe Marinari) will be collected in a prospective database, to monitor the postoperative course.
arm group label: Group Rome
description: All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UOC Chirurgia Generale & Bariatric Center of Excellence IFSO-EC, University La Sapienza of Rome, Italy (Head Prof. Gianfranco Silecchia) will be collected in a prospective database, to monitor the postoperative course.
intervention type: Procedure
intervention name: Bariatric procedures
description: All standard, laparoscopic bariatric procedures endorsed by SICOB (Società Italiana della Chirurgia dell'Obesità, Italian Society of Obesity Surgery) and by IFSO (International Federation of the Societies of Obesity Surgery), will be considered: sleeve gastrectomy, R-en-Y gastric bypass, one anastomosis gastric bypass, single anastomosis duodeno-ileal bypass with sleeve. The selection criteria for the surgery candidates will comply to the latest guidelines for bariatric surgery endorsed by SICOB, IFSO and EAES (European Association of Endoscopic Surgery). All the participating centers will follow the usual recruitment protocol. Restart of the bariatric elective surgery is based on the guidelines of SICOB for the bariatric surgery restart in Italy during the COVID-19 phase 2-3 of endemics.
arm group label: Group Bergamo
arm group label: Group Bologna
arm group label: Group Milano
arm group label: Group Padova
arm group label: Group Pisa
arm group label: Group Rome
arm group label: Group Tor Vergata
arm group label: Group Torino
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
last name: Gianfranco Silecchia, Prof
phone: 003907736513304
email: gianfranco.silecchia@uniroma1.it
last name: Cristian E Boru, Dr
phone: 003907736513304
email: drcrisb@gmail.com
facility: 
status: Recruiting
contact: 
country: Italy
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PMID: 32328827
responsible party type: Principal Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Gianfranco Silecchia
investigator title: MD, PhD, Full Professor of Surgery
mesh term: COVID-19
mesh term: Virus Diseases
mesh term: Pneumonia, Viral
mesh term: Obesity
mesh term: Obesity, Morbid
sharing ipd: Yes
ipd description: All the data will be collected anonymously on a database by an independent data manager. All participants will have access to all recorded data through independent web access.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 12 months
ipd access criteria: restricted access, based on username and password dedicated for every group
ipd url: https://test-chirurgiabariatricadurantecovid.pantheonsite.io/