The purpose of this study is to determine whether the virus SARS-CoV-2, responsible for the disease COVID-19, is present in the abdominal cavity during emergency laparoscopic exploration in confirmed or suspected COVID-19 patients.
A new human coronavirus responsible for pneumonia, SARS-CoV-2, emerged in China in December
2019 and has spread rapidly worlwide. COVID-19, the disease caused by this virus, has a very
polymorphous clinical presentation, which ranges from upper respiratory tract infections to
acute respiratory distress syndrome. Research institutions are working restlessly to
elucidate the physiopathology of COVID-19 to develop new and more efficacious strategies on
diagnosis, treatment and prevention planning. However, many aspects of the disease process
are still unknown. Despite the lack of complete understanding of COVID-19, recommandations
from world health authorities to surgical societies have been published in order to prevent
viral transmission within the hospital setting. Concerning prevention of viral transmission
during laparoscopy on confirmed or suspected COVID-19 cases, strict measures were taken to
protect surgical and anesthesia staff. These recommandations are mainly based on avoiding
leak of pneumoperitoneum during surgical exploration as it may represent a potential source
of viral transmission, eventhough there is no scientific evidence on it. The lack of evidence
of this mode of transmission makes difficult to develop more appropriate and efficacious
recommandations. This study is designed to assess for the presence of SARS-CoV-2 virus in the
peritoneal serosa during emergency laparoscopy on confirmed or suspected COVID-19 cases.
During laparoscopic surgical exploration, 3 samples of pneumoperitoneum will be taken in 3
standardized steps of the procedure. Two more other samples of peritoneal effusion or
peritoneal lavage (in the absence of peritoneal effusion) and bile (if cholecystectomy is
performed) will also be collected.
Other: Collection of samples
Only in enrolled patient : different samples will be taken at different times of the surgery (3 samples of pneumoperitoneum, 1 sample of peritoneal effusion or peritoneal lavage fluid and 1 sample of bile, in case of cholecystectomy.
Inclusion Criteria:
- Age > 18 years old
- Patient COVID-19 diagnosed by positive RT-PCR SARS-CoV-2 for less than 10 days, or by
thorax CT-scan suggesting specificdiagnostic aspects of COVID-19 requiring abdominal
or gynecological surgery by emergency laparoscopy
OR
- Patient COVID-19 suspected requiring abdominal or gynecological surgery by emergency
laparoscopy. Suspicion will be defined by the presence of at least one of the
following symptoms:
- Cough for less than 15 days
- Fever which appeared recently and which excluded another etiology
- Anosmia without obstructive rhinitis
- Contact with a COVID-19 + case person less than 21 days ago
- Patient requiring abdominal or gynecological surgery by emergency laparoscopy and who
should be tested by RT-PCR SARS-CoV-2
- Written and signed consent of the patient or guardian or family or, if this is not
possible, emergency inclusion procedure
- Patients with affiliation to French social security system
Exclusion Criteria:
- Patient already participating in research involving the human person
- Negative RT-PCR SARS-CoV-2
- Withdrawal of patient or guardian or family; or refusal to sign the required inform
consent form to continue to participate in the Clinical Trial
CH Victor Dupouy
Argenteuil, France
CH Intercommunal
Créteil, France
Department of General and Digestive Surgery, Hospital René Dubos
Pontoise, France
Department of Gynecology-Obstetrics, Hospital René Dubos
Pontoise, France
CH Delafontaine
Saint-Denis, France
Nelson Trelles, Principal Investigator
Centre Hospitalier René Dubos