Risk of Air Contamination During Visceral Surgery in COVID19 Patients

Not Applicable

• Conditions: Sars-CoV2; Surgery; COVID
• Interventions: Other: Cartography of air contamination, environment contamination and biological fluid by Sars-Cov2 during visceral surgery in COVID19 patients.

• Registration Number: NCT04395599
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-20
• Study Start: 2021-11-16
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-17
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COVID19 patients undergoing visceral surgery	Cartography of air contamination, environment contamination and biological fluid by Sars-Cov2 during visceral surgery in COVID19 patients.	-

Primary Outcome Measures

Name	Time	Method
Air contamination	10 minutes after incision if no opening of the digestive lumen, or 10 minutes after opening of the digestive tract	Composite criteria: "50cm above the operating site" and/or "1m50 from the operating site" and/or "3m from the operating site"

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hop Claude Huriez Chu Lille; 🇫🇷 Lille, France