Risk of Air Contamination During Visceral Surgery in COVID19 Patients (COELIOCOVID)

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Hop Claude Huriez Chu Lille

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COVID19 patients undergoing visceral surgery	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

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Robert Caiazzo, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Actual): January 27, 2022
• Study Completion (Actual): January 27, 2022

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: COVID-19; prevention; visceral surgery; air contamination; laparoscopy, prevention
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: 2020_44; 2020-A01461-38 (Other Identifier: ID-RCB number,ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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