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Risk of Air Contamination During Visceral Surgery in COVID19 Patients

NCT ID: NCT04395599

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-16

Study Completion Date

2022-01-27

Brief Summary

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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

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Conditions

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Sars-CoV2 Surgery COVID

Keywords

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COVID-19 visceral surgery air contamination laparoscopy, prevention prevention

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

COVID19 patients undergoing visceral surgery
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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COVID19 patients undergoing visceral surgery

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert CAIAZZO, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Claude Huriez Chu Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2020-A01461-38

Identifier Type: OTHER

Identifier Source: secondary_id

2020_44

Identifier Type: -

Identifier Source: org_study_id