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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronavirus Infection
• Intervention / Treatment: Other: Collection of samples

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Argenteuil, France, 95107
    • Ch Victor Dupouy
  • Créteil, France, 94000
    • CH Intercommunal
  • Pontoise, France, 95300
    • Department of General and Digestive Surgery, Hospital René Dubos
  • Pontoise, France, 95300
    • Department of Gynecology-Obstetrics, Hospital René Dubos
  • Saint-Denis, France, 93200
    • Ch Delafontaine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier René Dubos
• Investigators: Principal Investigator: Nelson Trelles, Centre Hospitalier René Dubos

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2020
• Primary Completion (Actual): December 16, 2021
• Study Completion (Actual): January 18, 2022

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Coronavirus Infections; SARS-CoV-2; COVID-19; pneumoperitoneum; Emergency laparoscopy
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: CHRD 0420

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No