<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/NCT04444687</url>
  </required_header>
  <id_info>
    <org_study_id>052020</org_study_id>
    <nct_id>NCT04444687</nct_id>
  </id_info>
  <brief_title>COVID 19: Is SARS-CoV-2 Contaminating Surgical Aerosols From Laparoscopy and Open Abdominal Surgery?</brief_title>
  <acronym>LapCoVIDSurg</acronym>
  <official_title>Is SARS-CoV-2 Contaminating Surgical Aerosols From Laparoscopy and Open Abdominal Surgery?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      This study aims at answering the question if aerosols from laparoscopic or open abdominal&#xD;
      surgery contain SARS-CoV-2 virus and need to be considered contagious.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The CoVID-19 pandemic has led to wide spread shut down of surgical services and restrictions&#xD;
      to emergency procedures in most European countries and the United States. Next to concerns&#xD;
      about resource limitations this has been justified by the risk of viral transmission during&#xD;
      surgery. As to date the virus has been isolated from several body fluids with highest viral&#xD;
      loads in the respiratory tract but also in feces. Aerosol producing interventions such as&#xD;
      intubation have been proven to be a common source of health care worker infections in Italy&#xD;
      and recently in the United Kingdom and the United States. The risk of surgical smoke and&#xD;
      steam in open and laparoscopic surgery has been considered to bear similar risk but no data&#xD;
      concerning these aerosols has been published so far and to the knowledge of the investigators&#xD;
      no trials are under way (www.clinicaltrials.gov 5.4.2020). Only limited data has been&#xD;
      available for other viral infections such as Hepatitis B and Human Papilloma Virus showing&#xD;
      that surgical aerosols have the potential to carry such infectious particles. This rational&#xD;
      has led to conflicting recommendations by surgical societies such as the Royal College of&#xD;
      Surgeons or the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) to avoid&#xD;
      laparoscopic procedures or use special filtration systems to evacuate the smoke and aerosols&#xD;
      from the body cavity.&#xD;
&#xD;
      Since Switzerland and the city of Basel in particular currently have a high prevalence for&#xD;
      CoVID 19 it is likely that surgeons will encounter patients with proven or suspected&#xD;
      infection in the near future that require open or laparoscopic emergency surgical procedures.&#xD;
      This offers the opportunity to collect a reasonable number of samples and smears from the&#xD;
      abdominal cavity and surgical aerosols from these patients in limited time to answer the&#xD;
      urgent question whether surgical smoke and aerosols of the abdominal cavity from CoVID-19&#xD;
      patients are contagious or not.&#xD;
&#xD;
      Investigators consider the trial to be a risk category A according to art 7 (HRO). There is&#xD;
      no risk for patients included in this trial since the treatment of the patients will not&#xD;
      differ from standard care. There will be no extra tests performed and only routine data will&#xD;
      be collected. Specimen from laparoscopic smoke filters which are a protection device for&#xD;
      medical staff will be tested on SARS-CoV-2 contamination.&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      The primary objective of the study is to investigate the contamination of surgical smoke and&#xD;
      aerosols with SARS-COV-2 virus particles using the viral genome as a marker during&#xD;
      laparoscopic and open abdominal emergency procedures for patients with suspected or proven&#xD;
      infection.&#xD;
&#xD;
      Secondary objectives are to:&#xD;
&#xD;
        -  assess the viral load in the peritoneal cavity and fluid&#xD;
&#xD;
        -  compare viral load of smoke and aerosols in laparoscopic and open procedures&#xD;
&#xD;
        -  assess possible transmission to surgeons during their service&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No patients&#xD;
  </why_stopped>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>SARS-COV-2 RNA detection</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>The primary outcome will be SARS-COV-2 RNA detection in filter systems for surgical aerosols in laparoscopic surgery (YES/NO).&#xD;
If viral RNA can be detected, the aerosols should be considered contagious, and therefore the debate on protective measures for the surgical staff in case of emergency surgery and possibly delaying any urgent surgery to protect surgical teams would be reasonable.&#xD;
If viral RNA cannot be detected, the aerosols do not need to be considered contagious for SARS-CoV-2, and CoVID-19 patients could safely be considered for laparoscopic and open abdominal surgery if indicated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Viral contamination of peritoneal cavity and fluid</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Viral contamination of peritoneal cavity and fluid in laparoscopic cases (YES/NO)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral contamination of peritoneal cavity and fluid in open cases</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Viral contamination of peritoneal cavity and fluid in open cases (YES/NO)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral infection of members of the surgical team</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Viral infection of members of the surgical team (YES/NO)</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>SARS-CoV-2-positive 01</arm_group_label>
    <description>SARS-CoV-2-positive patient, no symptoms, low viral load in tracheal aspirate, RNAemia not detectable</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SARS-CoV-2-positive 02</arm_group_label>
    <description>SARS-CoV-2-positive patient, symptoms, high viral load in tracheal aspirate, RNAemia not detectable</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SARS-CoV-2-positive 03</arm_group_label>
    <description>SARS-CoV-2-positive patient, symptoms, high viral load in tracheal aspirate, RNAemia detectable</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Control patients, SARS-CoV-2-negative</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Test for SARS-CoV-2</intervention_name>
    <description>As part of normal emergency evaluation due to symptoms or following standard operation procedure for patients heading to the operating theatre the status for SARS-CoV-2 is evaluated (gene expert, Roche)&#xD;
After intubation samples are acquired in the OR&#xD;
tracheal aspirate specimen directly after intubation (as part of standard operation procedures for CoVID-19 patients)&#xD;
blood sample (as part of standard operation procedures for CoVID-19 patients)&#xD;
fluid sample and smears from abdominal cavity as soon as this is accessed either by laparoscopy or laparotomy&#xD;
Sample from laparoscopic smoke filters (Laparoshield™ Laparoscopic Smoke Filtration System)&#xD;
Fluid samples and smears are frozen at -80 degrees celcius for conservation in the OR.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>SARS-CoV-2-positive 01</arm_group_label>
    <arm_group_label>SARS-CoV-2-positive 02</arm_group_label>
    <arm_group_label>SARS-CoV-2-positive 03</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tracheal aspirate, blood sample, fluid sample/smears from abdominal cavity, Sample from&#xD;
      laparoscopic smoke filters&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Inhabitants of the area around Basel/North west Switzerland&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Proven or suspected (not ruled out) SARS-CoV-2 infection (at the time of surgery)&#xD;
&#xD;
          -  Undergoing urgent or emergency laparoscopic or open abdominal surgery&#xD;
&#xD;
          -  Able to provide informed general consent on further use of clinical data&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Unable to provide informed general consent &amp; no possibility of informed general&#xD;
             consent by proxy&#xD;
&#xD;
          -  Recent (&lt;24h) negative test for SARS-CoV-2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marco von Strauss und Torney</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clarunis University Centre for Gastrointestinal and Liver Diseases</affiliation>
  </overall_official>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT04444687
org study id: 052020
nct id: NCT04444687
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims at answering the question if aerosols from laparoscopic or open abdominal
      surgery contain SARS-CoV-2 virus and need to be considered contagious.
The CoVID-19 pandemic has led to wide spread shut down of surgical services and restrictions
      to emergency procedures in most European countries and the United States. Next to concerns
      about resource limitations this has been justified by the risk of viral transmission during
      surgery. As to date the virus has been isolated from several body fluids with highest viral
      loads in the respiratory tract but also in feces. Aerosol producing interventions such as
      intubation have been proven to be a common source of health care worker infections in Italy
      and recently in the United Kingdom and the United States. The risk of surgical smoke and
      steam in open and laparoscopic surgery has been considered to bear similar risk but no data
      concerning these aerosols has been published so far and to the knowledge of the investigators
      no trials are under way (www.clinicaltrials.gov 5.4.2020). Only limited data has been
      available for other viral infections such as Hepatitis B and Human Papilloma Virus showing
      that surgical aerosols have the potential to carry such infectious particles. This rational
      has led to conflicting recommendations by surgical societies such as the Royal College of
      Surgeons or the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) to avoid
      laparoscopic procedures or use special filtration systems to evacuate the smoke and aerosols
      from the body cavity.

      Since Switzerland and the city of Basel in particular currently have a high prevalence for
      CoVID 19 it is likely that surgeons will encounter patients with proven or suspected
      infection in the near future that require open or laparoscopic emergency surgical procedures.
      This offers the opportunity to collect a reasonable number of samples and smears from the
      abdominal cavity and surgical aerosols from these patients in limited time to answer the
      urgent question whether surgical smoke and aerosols of the abdominal cavity from CoVID-19
      patients are contagious or not.

      Investigators consider the trial to be a risk category A according to art 7 (HRO). There is
      no risk for patients included in this trial since the treatment of the patients will not
      differ from standard care. There will be no extra tests performed and only routine data will
      be collected. Specimen from laparoscopic smoke filters which are a protection device for
      medical staff will be tested on SARS-CoV-2 contamination.

      Primary Objective:

      The primary objective of the study is to investigate the contamination of surgical smoke and
      aerosols with SARS-COV-2 virus particles using the viral genome as a marker during
      laparoscopic and open abdominal emergency procedures for patients with suspected or proven
      infection.

      Secondary objectives are to:

        -  assess the viral load in the peritoneal cavity and fluid

        -  compare viral load of smoke and aerosols in laparoscopic and open procedures

        -  assess possible transmission to surgeons during their service
observational model: Case-Control
time perspective: Prospective
measure: SARS-COV-2 RNA detection
time frame: Up to 12 months
description: The primary outcome will be SARS-COV-2 RNA detection in filter systems for surgical aerosols in laparoscopic surgery (YES/NO).
If viral RNA can be detected, the aerosols should be considered contagious, and therefore the debate on protective measures for the surgical staff in case of emergency surgery and possibly delaying any urgent surgery to protect surgical teams would be reasonable.
If viral RNA cannot be detected, the aerosols do not need to be considered contagious for SARS-CoV-2, and CoVID-19 patients could safely be considered for laparoscopic and open abdominal surgery if indicated.
measure: Viral contamination of peritoneal cavity and fluid
time frame: Up to 12 months
description: Viral contamination of peritoneal cavity and fluid in laparoscopic cases (YES/NO)
measure: Viral contamination of peritoneal cavity and fluid in open cases
time frame: Up to 12 months
description: Viral contamination of peritoneal cavity and fluid in open cases (YES/NO)
measure: Viral infection of members of the surgical team
time frame: Up to 12 months
description: Viral infection of members of the surgical team (YES/NO)
arm group label: SARS-CoV-2-positive 01
description: SARS-CoV-2-positive patient, no symptoms, low viral load in tracheal aspirate, RNAemia not detectable
arm group label: SARS-CoV-2-positive 02
description: SARS-CoV-2-positive patient, symptoms, high viral load in tracheal aspirate, RNAemia not detectable
arm group label: SARS-CoV-2-positive 03
description: SARS-CoV-2-positive patient, symptoms, high viral load in tracheal aspirate, RNAemia detectable
arm group label: Control
description: Control patients, SARS-CoV-2-negative
intervention type: Diagnostic Test
intervention name: Test for SARS-CoV-2
description: As part of normal emergency evaluation due to symptoms or following standard operation procedure for patients heading to the operating theatre the status for SARS-CoV-2 is evaluated (gene expert, Roche)
After intubation samples are acquired in the OR
tracheal aspirate specimen directly after intubation (as part of standard operation procedures for CoVID-19 patients)
blood sample (as part of standard operation procedures for CoVID-19 patients)
fluid sample and smears from abdominal cavity as soon as this is accessed either by laparoscopy or laparotomy
Sample from laparoscopic smoke filters (Laparoshield™ Laparoscopic Smoke Filtration System)
Fluid samples and smears are frozen at -80 degrees celcius for conservation in the OR.
arm group label: Control
arm group label: SARS-CoV-2-positive 01
arm group label: SARS-CoV-2-positive 02
arm group label: SARS-CoV-2-positive 03
Tracheal aspirate, blood sample, fluid sample/smears from abdominal cavity, Sample from
      laparoscopic smoke filters
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marco von Strauss und Torney
role: Principal Investigator
affiliation: Clarunis University Centre for Gastrointestinal and Liver Diseases
responsible party type: Sponsor
sharing ipd: No