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Completed

NCT Number: NCT04395599

Risk of Air Contamination During Visceral Surgery in COVID19 Patients

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.

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Key information

Conditions

Sars-CoV2 COVID COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Surgery Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hop Claude Huriez Chu Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Air contamination

    Time frame: 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 outcomes

  1. Environment contamination

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

    Cartography of Sars-Cov2 environment surface contamination

  2. Surgical approach

    Time frame: 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)

  3. Opening of the digestive tract

    Time frame: 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)

  4. Biological fluids

    Time frame: 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)

  5. Pneumoperitoneum

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

    Presence of Sars-Cov 2 in pneumoperitoneum, evaluated on surgical smoke filter

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: COELIOCOVID

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 20, 2020
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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