COELIOCOVID: Risk of Air Contamination During Visceral Surgery in COVID19 Patients

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT04395599

Collaborator

(none)

Enrollment

Location

Arm

11.5

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sars-CoV2 Surgery COVID	Other: Cartography of air contamination, environment contamination and biological fluid by Sars-Cov2 during visceral surgery in COVID19 patients.	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

COVID19 patients undergoing visceral surgeryCOVID19 patients undergoing visceral surgery

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 16, 2021

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Air contamination [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 Outcome Measures

Environment contamination [At the end of surgery, an average 1 hour 30 min]
Cartography of Sars-Cov2 environment surface contamination
Surgical approach [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)
Opening of the digestive tract [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)
Biological fluids [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)
Pneumoperitoneum [At the end of the procedure,an average 2 hours 30 min]
Presence of Sars-Cov 2 in pneumoperitoneum, evaluated on surgical smoke filter

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hop Claude Huriez Chu Lille	Lille		France	59037

Sponsors and Collaborators

University Hospital, Lille

Investigators

Principal Investigator: Robert CAIAZZO, MD,PhD, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Lille

ClinicalTrials.gov Identifier:

NCT04395599

Other Study ID Numbers:

2020_44
2020-A01461-38

First Posted:

May 20, 2020

Last Update Posted:

Mar 17, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Lille

COVID-19

visceral surgery

air contamination

laparoscopy, prevention

prevention

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Mar 17, 2022