Condition category
Respiratory
Date applied
14/05/2020
Date assigned
02/07/2020
Last edited
02/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Ruggero Bollino

ORCID ID

http://orcid.org/0000-0002-5585-1262

Contact details

General and Emergency Surgery Unit
Santa Maria Nuova Hospital
Risorgimento Avenue
80
Reggio Emilia
42123
Italy
+39 (0)522 296451
ruggero.bollino@ausl.re.it

Type

Scientific

Additional contact

Dr Maurizio Zizzo

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

600/2020/OSS/AUSLRE

Study information

Scientific title

Detection of the COVID-19 virus, SARS-CoV-2, in surgical smoke during Laparoscopic Surgery (CoV2_LapSurg): a pilot investigation

Acronym

CoV2_LapSurg

Study hypothesis

SARS-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

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

Study design

Single-centre prospective observational pilot study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

COVID-19 (SARS-CoV-2 infection) detection in minimally invasive surgery

Intervention

This 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 type

Device

Phase

Not Specified

Drug names

Biosampler (SKC Inc, AMS Analitica)

Primary outcome measure

Correct 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 measures

There are no secondary outcome measures

Overall trial start date

23/04/2020

Overall trial end date

24/06/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

Patients not able to give their informed consent

Recruitment start date

25/05/2020

Recruitment end date

25/05/2021

Locations

Countries of recruitment

Italy

Trial participating centre

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

Sponsor information

Organisation

Azienda Sanitaria Unità Locale di Reggio Emilia

Sponsor details

Viale Risorgimento 80
Reggio Emilia
42123
Italy
+39 (0)522296111
bonilauri.stefano@ausl.re.it

Sponsor type

Hospital/treatment centre

Website

http://www.asmn.re.it/

Funders

Funder type

Hospital/treatment centre

Funder name

Azienda Sanitaria Unità Locale di Reggio Emilia

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We planned to publish the results early after the first cases analyzed and then at the end of the study.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/06/2021

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

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).