COVIDLapCoVIDSurgNCT04444687
COVID 19: Is SARS-CoV-2 Contaminating Surgical Aerosols From Laparoscopy and Open Abdominal Surgery?
An observational study of COVID, run by University Hospital, Basel, Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID
- What is being tested?
- Test for SARS-CoV-2
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inhabitants of the area around Basel/North west Switzerland
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Is SARS-CoV-2 Contaminating Surgical Aerosols From Laparoscopy and Open Abdominal Surgery?
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.
Read the 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
- Conditions
- COVID
- Being tested
- Test for SARS-CoV-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test for SARS-CoV-2Diagnostic test
- 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.
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2-positive 01 | SARS-CoV-2-positive patient, no symptoms, low viral load in tracheal aspirate, RNAemia not detectable Receives: Diagnostic Test: Test for SARS-CoV-2 | |
| SARS-CoV-2-positive 02 | SARS-CoV-2-positive patient, symptoms, high viral load in tracheal aspirate, RNAemia not detectable Receives: Diagnostic Test: Test for SARS-CoV-2 | |
| SARS-CoV-2-positive 03 | SARS-CoV-2-positive patient, symptoms, high viral load in tracheal aspirate, RNAemia detectable Receives: Diagnostic Test: Test for SARS-CoV-2 | |
| Control | Control patients, SARS-CoV-2-negative Receives: Diagnostic Test: Test for SARS-CoV-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-COV-2 RNA detection
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.
Measured: Up to 12 months
Secondary outcomes (3)
Viral contamination of peritoneal cavity and fluid
Viral contamination of peritoneal cavity and fluid in laparoscopic cases (YES/NO)
Measured: Up to 12 months
Viral contamination of peritoneal cavity and fluid in open cases
Viral contamination of peritoneal cavity and fluid in open cases (YES/NO)
Measured: Up to 12 months
Viral infection of members of the surgical team
Viral infection of members of the surgical team (YES/NO)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study startAug 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionFeb 2021 (estimated)
Why it stopped: No patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco von Strauss und Torney, Principal investigator, Clarunis University Centre for Gastrointestinal and Liver Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444687
- Sponsor's protocol ID
- 052020
- Acronym
- LapCoVIDSurg
- Status last verified
- May 2022
- First submitted
- 15 Jun 2020
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is SARS-CoV-2 Contaminating Surgical Aerosols From Laparoscopy and Open Abdominal Surgery?
- ClinicalTrials.gov ID
- NCT04444687
- Acronym / sponsor ID
- LapCoVIDSurg / 052020
- Conditions
- COVID
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2-positive 01 | – | Diagnostic Test: Test for SARS-CoV-2SARS-CoV-2-positive patient, no symptoms, low viral load in tracheal aspirate, RNAemia not detectable |
| SARS-CoV-2-positive 02 | – | Diagnostic Test: Test for SARS-CoV-2SARS-CoV-2-positive patient, symptoms, high viral load in tracheal aspirate, RNAemia not detectable |
| SARS-CoV-2-positive 03 | – | Diagnostic Test: Test for SARS-CoV-2SARS-CoV-2-positive patient, symptoms, high viral load in tracheal aspirate, RNAemia detectable |
| Control | – | Diagnostic Test: Test for SARS-CoV-2Control patients, SARS-CoV-2-negative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inhabitants of the area around Basel/North west Switzerland
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 1. tracheal aspirate specimen directly after intubation (as part of standard operation procedures for CoVID-19 patients) 2. blood sample (as part of standard operation procedures for CoVID-19 patients) 3. fluid sample and smears from abdominal cavity as soon as this is accessed either by laparoscopy or laparotomy 4. 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. | Diagnostic test | Control, SARS-CoV-2-positive 01, SARS-CoV-2-positive 02, SARS-CoV-2-positive 03 |
Primary outcome
SARS-COV-2 RNA detection
Time frame: Up to 12 months
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.
3 secondary outcomes
Viral contamination of peritoneal cavity and fluid
Time frame: Up to 12 months
Viral contamination of peritoneal cavity and fluid in open cases
Time frame: Up to 12 months
Viral infection of members of the surgical team
Time frame: Up to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco von Strauss und Torney principal investigator
Clarunis University Centre for Gastrointestinal and Liver Diseases
Questions about this trial
What is this clinical trial studying?
An observational study of COVID, run by University Hospital, Basel, Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-COV-2 RNA detection (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.