Risk of Air Contamination During Visceral Surgery in COVID19 Patients

Surgery Clinical Trial

— COELIOCOVID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04395599
• Other study ID #: 2020_44
• Secondary ID: 2020-A01461-38
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2021
• Est. completion date: November 2022

Study information

• Verified date: March 2022
• Source: University Hospital, Lille
• Contact: Robert CAIAZZO, MD,PhD
• Phone: 32044
• Email: robert.caiazzo[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID
• COVID-19
• Sars-CoV2
• Surgery

Intervention

Other:
• Cartography of air contamination, environment contamination and biological fluid by Sars-Cov2 during visceral surgery in COVID19 patients.
Air sampling, operating room surfaces sampling and patients' biological fluid sampling for Sars-Cov2 quantification

Locations

Country	Name	City	State
France	Hop Claude Huriez Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Environment contamination	Cartography of Sars-Cov2 environment surface contamination	At the end of surgery, an average 1 hour 30 min
Secondary	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
Secondary	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
Secondary	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
Secondary	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