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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collection of samples | Other | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of samples | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the presence of the SARS-COV-2 virus at T4 | Assessment of the presence of the SARS-COV-2 virus by RT-PCR in the peritoneum at the end of the surgical procedure with exsufflation (T4) in COVID-19 patients | After surgery, an average of half a day |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the presence of the SARS-COV-2 virus at T1 | Assessment of the presence of the SARS-COV-2 virus by RT-PCR immediately after creation of the pneumoperitoneum just before intraperitoneal surgical exploration (T1) in COVID-19 patients | After surgery, an average of half a day |
| Assessment of the presence of the SARS-COV-2 virus in the peritoneal effusion at T2 or T4 |
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Inclusion Criteria:
OR
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nelson Trelles | Hôpital NOVO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Victor Dupouy | Argenteuil | 95107 | France | |||
| CH Intercommunal |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D011027 | Pneumoperitoneum |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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Assessment of the presence of the SARS-COV-2 virus by RT-PCR in the peritoneal effusion found during surgical exploration (T2) or in the peritoneal lavage fluid at the end of the surgical procedure before exsufflation (T4) in COVID-19 patients |
| After surgery, an average of half a day |
| Assessment of the presence of the SARS-COV-2 virus at T3 | Assessment of the presence of the SARS-COV-2 virus by RT-PCR in the pneumoperitoneum during intraperitoneal surgical dissection (T2) with straight blunt/sharp or any kind of energy devices in COVID-19 patients | After surgery, an average of half a day |
| Assessment of the presence of the SARS-COV-2 virus at T5 | Assessment of the presence of the SARS-COV-2 virus by RT-PCR in the bile at the end of the intervention after specimen extraction (T5), in case a cholecystectomy is performed in COVID-19 patients | After surgery, an average of half a day |
| Créteil |
| 94000 |
| France |
| Department of General and Digestive Surgery, Hospital René Dubos | Pontoise | 95300 | France |
| Department of Gynecology-Obstetrics, Hospital René Dubos | Pontoise | 95300 | France |
| CH Delafontaine | Saint-Denis | 93200 | France |
| D007239 |
| Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |