Laparoscopy and COVID-19 Contamination

NCT04608383 | Unknown

• 1 other identifier: APHP200611
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

The aim of the study is to search the presence of the SARS-COV-2 virus (COVID19) in the pneumoperitoneum of patients with a positive (or suspected) COVID19 status during a routine laparoscopy.

Conditions

Covid19

Keywords

LAPAROSCOPY; pneumoperitoneum

Outcome Measures

Primary Outcomes (1)

• The main objective of the study is to demonstrate the presence of SARS-COV-2 in the exsufflated gas at the end of laparoscopy.

  The SARS-COV-2 will be looked for in the gas before its elimination at the end of the intervention. To this end, the PCR search will be carried out on the filter used

  Day 1 , at the end of the surgery

Secondary Outcomes (1)

• The secondary objective of the study is to demonstrate the presence of SARS-COV-2 in the peritoneal fluid during laparoscopy

  Day 1 , at the end of the surgery

Interventions

Additional and minimal collection of products of the human body carried out during a sample for standard of care OTHER

* Swab of the peritoneal fluid for traces of COVID19. The collection of peritoneal fluid is a standard care practice. * Swab from the laparoscopy filter

Eligibility Criteria

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

Study Population

Any adult requiring a laparoscopic procedure with a positive or suspected Covid19 status.

You may qualify if:

• Patient of legal age
• Indication for laparoscopy
• Positive (past or current) or suspected Covid19 status (cough, fever, suggestive radiological images, etc.)
• Lack of opposition to participating in the study

You may not qualify if:

• Patient under legal protection
• Covid19 status negative, (former or current) and not suspected
• Patient unable to object
• Patient with no social security care

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (4)

AP-HP, Bicêtre Hospital, Anesthesia Department

Le Kremlin-Bicêtre, 94275, France

RECRUITING

AP-HP, Bicêtre Hospital, Department of Digestive and Oncological Surgery

Le Kremlin-Bicêtre, 94275, France

RECRUITING

AP-HP, Bicêtre Hospital, Gynecology department

Le Kremlin-Bicêtre, 94275, France

RECRUITING

AP-HP, Bicêtre Hospital, Urology Department

Le Kremlin-Bicêtre, 94275, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Excess peritoneal fluid, usually taken during laparoscopy Exsufflation of the pneumoperitoneum through a filter

MeSH Terms

Conditions

COVID-19; Pneumoperitoneum

Interventions

Standard of Care

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; Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Laura RUSCIO

CONTACT

+3301 45 21 34 41; laura.ruscio@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: October 29, 2020
• Study Start: November 19, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: March 2, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)