NCT04361396

Assessment of the Presence of the SARS-COV-2 Virus in the Peritoneum of COVID-19 Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Hôpital NOVO · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronavirus Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-16
• Primary completion: 2021-12-16
• Completion: 2022-01-18
• First posted: 2020-04-24
• Last updated: 2024-09-19

Locations

5 sites across 1 country: France