Risk of Air Contamination During Visceral Surgery in COVID19 Patients

NCT04395599 | Completed

• 2 other identifiers: 2020_442020-A01461-38
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; COVID; Sars-CoV2

Keywords

COVID-19; visceral surgery; air contamination; laparoscopy, prevention; prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Environment contamination

  At the end of surgery, an average 1 hour 30 min

• Surgical approach

  At the end of the intervention, an average 2 hours

• Opening of the digestive tract

  At the end of the intervention,an average 2 hours

• Biological fluids

  During the procedure, an average 2 hours 30 min

• Pneumoperitoneum

  At the end of the procedure,an average 2 hours 30 min

Study Arms (1)

COVID19 patients undergoing visceral surgery

EXPERIMENTAL

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

Interventions

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

Air sampling, operating room surfaces sampling and patients' biological fluid sampling for Sars-Cov2 quantification

COVID19 patients undergoing visceral surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Robert CAIAZZO, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: COVID19 patients undergoing visceral surgery

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 20, 2020
• Study Start: November 16, 2021
• Primary Completion: January 27, 2022
• Study Completion: January 27, 2022
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)