Laparoscopy and COVID-19 Contamination (LAPCOV)

February 26, 2021 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Kremlin Bicêtre, France, 94275
        • Recruiting
        • AP-HP, Bicêtre Hospital, Anesthesia Department
        • Contact:
      • Le Kremlin Bicêtre, France, 94275
        • Recruiting
        • AP-HP, Bicêtre Hospital, Gynecology department
        • Contact:
      • Le Kremlin-Bicêtre, France, 94275
        • Recruiting
        • AP-HP, Bicêtre Hospital, Department of Digestive and Oncological Surgery
        • Contact:
      • Le Kremlin-Bicêtre, France, 94275
        • Recruiting
        • AP-HP, Bicêtre Hospital, Urology Department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The main objective of the study is to demonstrate the presence of SARS-COV-2 in the exsufflated gas at the end of laparoscopy.
Time Frame: Day 1 , at the end of the surgery
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2020

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

October 23, 2020

First Submitted That Met QC Criteria

October 28, 2020

First Posted (Actual)

October 29, 2020

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

February 26, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP200611

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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