Covid19LAPCOVNCT04608383
Laparoscopy and COVID-19 Contamination
An observational study of Covid19, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 20 participants
- Where
- 4 sitesFrance
- Study dates
- 19 Nov 2020to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any adult requiring a laparoscopic procedure with a positive or suspected Covid19 status.
Who may be able to join
- 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
Who cannot join
- Patient under legal protection
- Covid19 status negative, (former or current) and not suspected
- Patient unable to object
- Patient with no social security care
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
AP-HP, Bicêtre Hospital, Anesthesia Department
Le Kremlin-Bicêtre, 94275
Laura RUSCIO, MD, PhD, +33(0)1 45 21 34 41, laura.ruscio@aphp.fr
- Recruiting
AP-HP, Bicêtre Hospital, Department of Digestive and Oncological Surgery
Le Kremlin-Bicêtre, 94275
STEPHANE BENOIST, PhD, MD, +33 (0)1 45 21 70 30, stephane.benoist@aphp.fr
- Recruiting
AP-HP, Bicêtre Hospital, Gynecology department
Le Kremlin-Bicêtre, 94275
Hervé FERNANDEZ, MD, PhD, +33(0)145217701, herve.fernandez@bct.aphp.fr
- Recruiting
AP-HP, Bicêtre Hospital, Urology Department
Le Kremlin-Bicêtre, 94275
Cedric LEBACLE, MD, PhD, +33 1 452121 70, cedric.lebacle@aphp.fr
About this study
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
- Being tested
- Additional and minimal collection of products of the human body carried out during a sample for standard of care
- Keywords
- LAPAROSCOPY, pneumoperitoneum
- Medical subject headings
- COVID-19, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional and minimal collection of products of the human body carried out during a sample for standard of careOther
- Swab of the peritoneal fluid for traces of COVID19. The collection of peritoneal fluid is a standard care practice.
- Swab from the laparoscopy filter
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
SARS-COV-2 will be tested for by PCR in the peritoneal fluid collected during laparoscopy
Measured: Day 1 , at the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start19 Nov 2020
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608383
- Sponsor's protocol ID
- APHP200611
- Acronym
- LAPCOV
- Status last verified
- Oct 2020
- First submitted
- 23 Oct 2020
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopy and COVID-19 Contamination
- ClinicalTrials.gov ID
- NCT04608383
- Acronym / sponsor ID
- LAPCOV / APHP200611
- Conditions
- Covid19
- Keywords
- LAPAROSCOPY, pneumoperitoneum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any adult requiring a laparoscopic procedure with a positive or suspected Covid19 status.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Patient under legal protection
- Covid19 status negative, (former or current) and not suspected
- Patient unable to object
- Patient with no social security care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura RUSCIO (+3301 45 21 34 41, laura.ruscio@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.