Clinical trial NCT04361396: Assessment of the Presence of the SARS-COV-2 Virus in the Peritoneum of COVID-19 Patients
Official title: Assessment of the Presence of the SARS-COV-2 Virus in the Peritoneum During an Emergency Laparoscopy Conducted on Confirmed or Suspected COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronavirus Infection
Keywords: Emergency laparoscopy
Coronavirus Infections
SARS-CoV-2
pneumoperitoneum
COVID-19
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the presence of the SARS-COV-2 virus at T4
timeFrame: After surgery, an average of half a day
Secondary outcomes:
measure: Assessment of the presence of the SARS-COV-2 virus at T1
timeFrame: After surgery, an average of half a day
measure: Assessment of the presence of the SARS-COV-2 virus in the peritoneal effusion at T2 or T4
timeFrame: After surgery, an average of half a day
measure: Assessment of the presence of the SARS-COV-2 virus at T3
timeFrame: After surgery, an average of half a day
measure: Assessment of the presence of the SARS-COV-2 virus at T5
timeFrame: After surgery, an average of half a day
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: CH Victor Dupouy
city: Créteil
country: France
facility: CH Intercommunal
city: Pontoise
country: France
facility: Department of General and Digestive Surgery, Hospital René Dubos
city: Pontoise
country: France
facility: Department of Gynecology-Obstetrics, Hospital René Dubos
city: Saint-Denis
country: France
facility: CH Delafontaine
Study officials:
affiliation: Hôpital NOVO
name: Nelson Trelles
role: PRINCIPAL_INVESTIGATOR
References: