Clinical trial NCT04444687: COVID 19: Is SARS-CoV-2 Contaminating Surgical Aerosols From Laparoscopy and Open Abdominal Surgery?
Official title: Is SARS-CoV-2 Contaminating Surgical Aerosols From Laparoscopy and Open Abdominal Surgery?
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: COVID
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inhabitants of the area around Basel/North west Switzerland

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: SARS-COV-2 RNA detection
timeFrame: Up to 12 months
Secondary outcomes:
measure: Viral contamination of peritoneal cavity and fluid
timeFrame: Up to 12 months
measure: Viral contamination of peritoneal cavity and fluid in open cases
timeFrame: Up to 12 months
measure: Viral infection of members of the surgical team
timeFrame: Up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Clarunis University Centre for Gastrointestinal and Liver Diseases
name: Marco von Strauss und Torney
role: PRINCIPAL_INVESTIGATOR
References: