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
Diagnostic Test: Test for SARS-CoV-2
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.
Inclusion Criteria:
- Age ≥ 18 years
- Proven or suspected (not ruled out) SARS-CoV-2 infection (at the time of surgery)
- Undergoing urgent or emergency laparoscopic or open abdominal surgery
- Able to provide informed general consent on further use of clinical data
Exclusion Criteria:
- Age < 18 years
- Unable to provide informed general consent & no possibility of informed general
consent by proxy
- Recent (<24h) negative test for SARS-CoV-2
Marco von Strauss und Torney, Principal Investigator
Clarunis University Centre for Gastrointestinal and Liver Diseases