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

Primary Purpose

Sars-CoV2, Surgery, COVID

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cartography of air contamination, environment contamination and biological fluid by Sars-Cov2 during visceral surgery in COVID19 patients.
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sars-CoV2 focused on measuring COVID-19, visceral surgery, air contamination, laparoscopy, prevention, prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hop Claude Huriez Chu LilleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

COVID19 patients undergoing visceral surgery

Arm Description

Outcomes

Primary Outcome Measures

Air contamination
Composite criteria: "50cm above the operating site" and/or "1m50 from the operating site" and/or "3m from the operating site"

Secondary Outcome Measures

Environment contamination
Cartography of Sars-Cov2 environment surface contamination
Surgical approach
Composite criteria: air contamination or environment contamination positivity rate according to surgical approach (laparoscopy or laparotomy)
Opening of the digestive tract
Composite criteria: air contamination or environment contamination positivity rate according to opening of digestive tract status (opened or not)
Biological fluids
Cartography of Sars-Cov2 presence in biological fluids (blood, stools, peritoneal fluid, digestive fluids, sputum, bile)
Pneumoperitoneum
Presence of Sars-Cov 2 in pneumoperitoneum, evaluated on surgical smoke filter

Full Information

First Posted
May 19, 2020
Last Updated
March 14, 2022
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT04395599
Brief Title
Risk of Air Contamination During Visceral Surgery in COVID19 Patients
Acronym
COELIOCOVID
Official Title
Assessment of Air Contamination Risk by Sars-Cov2 During Visceral Surgery in COVID19 Patients: Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sars-CoV2, Surgery, COVID
Keywords
COVID-19, visceral surgery, air contamination, laparoscopy, prevention, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
COVID19 patients undergoing visceral surgery
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COVID19 patients undergoing visceral surgery
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Cartography of air contamination, environment contamination and biological fluid by Sars-Cov2 during visceral surgery in COVID19 patients.
Intervention Description
Air sampling, operating room surfaces sampling and patients' biological fluid sampling for Sars-Cov2 quantification
Primary Outcome Measure Information:
Title
Air contamination
Description
Composite criteria: "50cm above the operating site" and/or "1m50 from the operating site" and/or "3m from the operating site"
Time Frame
10 minutes after incision if no opening of the digestive lumen, or 10 minutes after opening of the digestive tract
Secondary Outcome Measure Information:
Title
Environment contamination
Description
Cartography of Sars-Cov2 environment surface contamination
Time Frame
At the end of surgery, an average 1 hour 30 min
Title
Surgical approach
Description
Composite criteria: air contamination or environment contamination positivity rate according to surgical approach (laparoscopy or laparotomy)
Time Frame
At the end of the intervention, an average 2 hours
Title
Opening of the digestive tract
Description
Composite criteria: air contamination or environment contamination positivity rate according to opening of digestive tract status (opened or not)
Time Frame
At the end of the intervention,an average 2 hours
Title
Biological fluids
Description
Cartography of Sars-Cov2 presence in biological fluids (blood, stools, peritoneal fluid, digestive fluids, sputum, bile)
Time Frame
During the procedure, an average 2 hours 30 min
Title
Pneumoperitoneum
Description
Presence of Sars-Cov 2 in pneumoperitoneum, evaluated on surgical smoke filter
Time Frame
At the end of the procedure,an average 2 hours 30 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert CAIAZZO, MD,PhD
Phone
32044
Ext
+33
Email
robert.caiazzo@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert CAIAZZO, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hop Claude Huriez Chu Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Risk of Air Contamination During Visceral Surgery in COVID19 Patients

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