COVID Clinical Trial
— LapCoVIDSurgOfficial title:
Is SARS-CoV-2 Contaminating Surgical Aerosols From Laparoscopy and Open Abdominal Surgery?
NCT number | NCT04444687 |
Other study ID # | 052020 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | August 2020 |
Est. completion date | February 2021 |
Verified date | May 2022 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2021 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Up to 12 months | |
Secondary | Viral contamination of peritoneal cavity and fluid | Viral contamination of peritoneal cavity and fluid in laparoscopic cases (YES/NO) | Up to 12 months | |
Secondary | Viral contamination of peritoneal cavity and fluid in open cases | Viral contamination of peritoneal cavity and fluid in open cases (YES/NO) | Up to 12 months | |
Secondary | Viral infection of members of the surgical team | Viral infection of members of the surgical team (YES/NO) | Up to 12 months |
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