Can the COVID-19 virus be detected in the smoke generated in minimally invasive surgery in patients with confirmed coronavirus infection?

ISRCTN ISRCTN18077365
DOI https://doi.org/10.1186/ISRCTN18077365
Secondary identifying numbers 600/2020/OSS/AUSLRE
Submission date
14/05/2020
Registration date
02/07/2020
Last edited
02/07/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.

The production of " smoke and fumes" due to the use of high energy devices in minimally invasive (laparoscopic) surgery to generate heat is well known. This smoke is composed of 95% water and 5% particles from the patient such as body cells and viruses. This represents a potential health risk due to the possibility of surgical healthcare workers contracting infectious diseases from this smoke.

Several studies have shown that laparoscopy can cause viruses that are carried in the blood to be present in these fumes, but to date, there is no evidence that this occurs with the novel coronavirus.

During the COVID-19 outbreak, despite the lack of evidence on whether the virus can be transmitted through this method, experts have advised that surgical staff take precautions to minimise the risk of this possible transmission during surgery.

This study aims to observe if SARS-CoV-2 particles can be detected in the fumes from laparoscopic surgery.

Who can participate?
Patients aged 18 to 90 years scheduled for a laparoscopic procedure at the participating hospital

What does the study involve?
Participants will have their scheduled surgical procedures. These will follow hospital and local guidelines. Additionally, participants will be required to give a blood sample prior to surgery which will be tested for COVID-19 and a Biosampler will be used during the procedure to collect particles from the fumes.

What are the possible benefits and risks of participating?
The benefits for those taking part in the study is to increase our knowledge of the possibility of transmission of the virus through the fumes generated during surgery. This has never been demonstrated but would provide evidence for an increase in safety measures to make surgery safer.

No serious adverse events are expected. If an adverse event occurs, this will be managed by the surgical team and recorded in the entries of our operating room check-list and will be communicated promptly to the investigator of the study. The event will be communicated within 5 days to the local healthcare authorities.

Where is the study run from?
Arcispedale Santa Maria Nuova (Italy)

When is the study starting and how long is it expected to run for?
From May 2020 to May 2021

Who is funding the study?
Local Health Unit of Reggio Emilia (Italy)

Who is the main contact?
1. Dr Ruggero Bollino
ruggero.bollino@ausl.re.it
2. Dr Maurizio Zizzo
maurizio.zizzo@ausl.re.it

Contact information

Dr Ruggero Bollino
Public

General and Emergency Surgery Unit
Santa Maria Nuova Hospital
Risorgimento Avenue, 80
Reggio Emilia
42123
Italy

ORCiD logoORCID ID 0000-0002-5585-1262
Phone +39 (0)522 296451
Email ruggero.bollino@ausl.re.it
Dr Maurizio Zizzo
Scientific

Surgical Oncology Unit
Department of Oncology and Advanced Technologies
Oncological and Hematological Center of Reggio Emilia (CORE)
Santa Maria Nuova Hospital
Risorgimento Avenue, 80
Reggio Emilia
42123
Italy

Phone +39 (0)522 296372
Email maurizio.zizzo@ausl.re.it

Study information

Study designSingle-centre prospective observational pilot study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleDetection of the COVID-19 virus, SARS-CoV-2, in surgical smoke during Laparoscopic Surgery (CoV2_LapSurg): a pilot investigation
Study acronymCoV2_LapSurg
Study objectivesSARS-CoV-2 particles will be isolated from the bioaerosol collected in solution during 20 consecutive major laparoscopic surgical procedures using the Biosampler (SKC Inc, AMS Analitica) and analysed using RT-PCR
Ethics approval(s)Approved 16/06/2020, The Ethics Committee of the Emilia Nord Vast Area (AVEN) (I.R.C.C.S - ASMN, Viale Umberto I, 50 – 42121 Reggio Emilia, Italy; +39 (0)522.296979; domenico.merlo@ausl.re.it), ref: 2020/0071828
Health condition(s) or problem(s) studiedCOVID-19 (SARS-CoV-2 infection) detection in minimally invasive surgery
InterventionThis is an observational trial. The study aims at analyzing with PCR the bioaerosol collected through the Biosampler (SKC Inc, AMS Analitica) in solution during 20 consecutive major laparoscopic surgical procedures to try to isolate Sars-CoV-2 particles. The presence of SARS-CoV-2 RNA in plasma of each patient will be measured before surgery using RT-PCR. There will be no follow-up of participants, all data is collected during the same surgical procedure.

The Biosampler will be connected through extension tubes to a trocar assigned to evacuate the pneumoperitoneum and to a negative pressure suction system with a flow of about 15L / min during the procedure. Surgical smoke will be collected for 30 min after major vessel exposure. The particles collected in 15 ml phosphate buffer case will then be sealed under sterile conditions and sent to the laboratory for investigation with PCR. Nucleic acid extraction will be executed by magnetic bead method on 1 ml of phosphate buffer derived by the Biosampler. A commercial One-Step Reverse Transcription Real-Time polymerase chain reaction (GeneFinder™ COVID -19 PLUS Real Real Amp Kit) will be performed in order to confirm the presence of Sars-Cov-2 in specimens by amplification of RdRp, E and N gene.
Intervention typeDevice
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Biosampler (SKC Inc, AMS Analitica)
Primary outcome measureCorrect detection of the presence of SARS-CoV-2 virus particles collected in surgical smoke during laparoscopic surgery through highly efficient Biosamplers and RT-PCR test when compared to the presence of SARS-CoV-2 RNA detected in plasma using RT-PCR in the same cohort prior to the procedure
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date23/04/2020
Completion date24/06/2021

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants20
Key inclusion criteria1. Diagnosis of COVID-19 confirmed through positive RT-PCR test before surgery
2. Scheduled laparoscopic procedure at least 1.5 h duration with major vessels exposure
3. Aged 18 to 90 years
Key exclusion criteriaPatients not able to give their informed consent
Date of first enrolment25/05/2020
Date of final enrolment25/05/2021

Locations

Countries of recruitment

  • Italy

Study participating centre

Arcispedale Santa Maria Nuova
Azienda USL-IRCCS di Reggio Emilia
Viale Risorgimento 80
Reggio Emilia
42123
Italy

Sponsor information

Azienda Sanitaria Unità Locale di Reggio Emilia
Hospital/treatment centre

Viale Risorgimento 80
Reggio Emilia
42123
Italy

Phone +39 (0)522296111
Email bonilauri.stefano@ausl.re.it
Website http://www.asmn.re.it/
ROR logo "ROR" https://ror.org/001bbwj30

Funders

Funder type

Hospital/treatment centre

Azienda Sanitaria Unità Locale di Reggio Emilia

No information available

Results and Publications

Intention to publish date01/06/2021
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planWe planned to publish the results early after the first cases analyzed and then at the end of the study.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Editorial Notes

02/07/2020: Internal review.
25/05/2020: Trial’s existence confirmed by the Ethics Committee of the Emilia Nord Vast Area (AVEN).