Risk of Air Contamination During Visceral Surgery in COVID19 Patients

Study Overview
=================
Brief Summary
-----------------
Sars-Cov2 has been found in the digestive tract, as well as the respiratory tract. Protection of health care workers during surgery has been increased and some guidelines advocate for abandoning laparoscopy in COVID19 patients for fear of contamination, evenghtough this does not benefit the patient. However, Sars-Cov2 contamination risk during visceral surgery remains unknown. Inadequate protection is unnecessary costful and can be inefficient if too binding. Our hypotheses are that 1) Sars-Cov 2 can travel through droplet and air during visceral surgery. 2) Laparoscopy, because of the pneumoperitoneum and its leaks, warrant more air contamination whereas laparotomy warrant more droplet contamination, which would justified increased protection.

Official Title
-----------------
Assessment of Air Contamination Risk by Sars-Cov2 During Visceral Surgery in COVID19 Patients: Pilot Study.

Conditions
-----------------
Sars-CoV2, Surgery, COVID

Intervention / Treatment
-----------------
* Other: Cartography of air contamination, environment contamination and biological fluid by Sars-Cov2 during visceral surgery in COVID19 patients.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented Sars-Cov2 infection (nasopharyngeal swab, tracheal sampling, thoracic CT, serology) Need of visceral surgery (laparoscopy or laparotomy) Signed informed consent Social coverage Patient who agrees to be included in the study and who signs the informed consent form Patient affiliated to a healthcare insurance plan Patient willing to comply with study's requirements Exclusion Criteria: Need of another type of surgery during the same procedure Mentally unbalanced patients, under supervision or guardianship Patient who does not understand French/ is unable to give consent Patient not affiliated to a French or European healthcare insurance Patient incarcerated

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: COVID19 patients undergoing visceral surgery
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVID19 patients undergoing visceral surgery<br> | Other: Cartography of air contamination, environment contamination and biological fluid by Sars-Cov2 during visceral surgery in COVID19 patients.<br>* Air sampling, operating room surfaces sampling and patients' biological fluid sampling for Sars-Cov2 quantification<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Air contamination | Composite criteria: 50cm above the operating site and/or 1m50 from the operating site and/or 3m from the operating site | 10 minutes after incision if no opening of the digestive lumen, or 10 minutes after opening of the digestive tract | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Environment contamination | Cartography of Sars-Cov2 environment surface contamination | At the end of surgery, an average 1 hour 30 min | 
| Surgical approach | Composite criteria: air contamination or environment contamination positivity rate according to surgical approach (laparoscopy or laparotomy) | At the end of the intervention, an average 2 hours | 
| Opening of the digestive tract | Composite criteria: air contamination or environment contamination positivity rate according to opening of digestive tract status (opened or not) | At the end of the intervention,an average 2 hours | 
| Biological fluids | Cartography of Sars-Cov2 presence in biological fluids (blood, stools, peritoneal fluid, digestive fluids, sputum, bile) | During the procedure, an average 2 hours 30 min | 
| Pneumoperitoneum | Presence of Sars-Cov 2 in pneumoperitoneum, evaluated on surgical smoke filter | At the end of the procedure,an average 2 hours 30 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevention, COVID-19, visceral surgery, air contamination, laparoscopy, prevention