Laparoscopy and COVID-19 Contamination

Covid19 Clinical Trial

— LAPCOV  

Official title:

Laparoscopy and COVID-19 Contamination

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04608383
• Other study ID #: APHP200611
• Status: Recruiting
• Start date: November 19, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: October 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Laura RUSCIO
• Phone: +3301 45 21 34 41
• Email: laura.ruscio[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patient under legal protection

• Covid19 status negative, (former or current) and not suspected

• Patient unable to object

• Patient with no social security care

Related Conditions & MeSH terms

• Covid19

Intervention

Other:
• Additional and minimal collection of products of the human body carried out during a sample for standard of care
Swab of the peritoneal fluid for traces of COVID19. The collection of peritoneal fluid is a standard care practice. Swab from the laparoscopy filter

Locations

Country	Name	City	State
France	AP-HP, Bicêtre Hospital, Anesthesia Department	Le Kremlin Bicêtre
France	AP-HP, Bicêtre Hospital, Gynecology department	Le Kremlin Bicêtre
France	AP-HP, Bicêtre Hospital, Department of Digestive and Oncological Surgery	Le Kremlin-Bicêtre
France	AP-HP, Bicêtre Hospital, Urology Department	Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The secondary objective of the study is to demonstrate the presence of SARS-COV-2 in the peritoneal fluid during laparoscopy	SARS-COV-2 will be tested for by PCR in the peritoneal fluid collected during laparoscopy	Day 1 , at the end of the surgery