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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 10
- 主要终点
- Assessment of the presence of the SARS-COV-2 virus at T4
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
结局指标
主要结局
Assessment of the presence of the SARS-COV-2 virus at T4
时间窗: After surgery, an average of half a day
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
次要结局
- Assessment of the presence of the SARS-COV-2 virus at T3(After surgery, an average of half a day)
- Assessment of the presence of the SARS-COV-2 virus at T5(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(After surgery, an average of half a day)
- Assessment of the presence of the SARS-COV-2 virus at T1(After surgery, an average of half a day)