NCT04361396

Brief Summary

The purpose of this study is to determine whether the virus SARS-CoV-2, responsible for the disease COVID-19, is present in the abdominal cavity during emergency laparoscopic exploration in confirmed or suspected COVID-19 patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 16, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2022

Completed
Last Updated

September 19, 2024

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

April 22, 2020

Last Update Submit

September 3, 2024

Conditions

Coronavirus Infection

Keywords

Emergency laparoscopyCoronavirus InfectionsSARS-CoV-2pneumoperitoneumCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Assessment of the presence of the SARS-COV-2 virus at T4

    Assessment of the presence of the SARS-COV-2 virus by RT-PCR in the peritoneum at the end of the surgical procedure with exsufflation (T4) in COVID-19 patients

    After surgery, an average of half a day

Secondary Outcomes (4)

  • Assessment of the presence of the SARS-COV-2 virus at T1

    After surgery, an average of half a day

  • Assessment of the presence of the SARS-COV-2 virus in the peritoneal effusion at T2 or T4

    After surgery, an average of half a day

  • Assessment of the presence of the SARS-COV-2 virus at T3

    After surgery, an average of half a day

  • Assessment of the presence of the SARS-COV-2 virus at T5

    After surgery, an average of half a day

Study Arms (1)

Collection of samples

OTHER

Only in enrolled patient : different samples will be taken at different times of the surgery (3 samples of pneumoperitoneum, 1 sample of peritoneal effusion or peritoneal lavage fluid and 1 sample of bile, in case of cholecystectomy).

Other: Collection of samples

Interventions

Collection of samplesOTHER

Only in enrolled patient : different samples will be taken at different times of the surgery (3 samples of pneumoperitoneum, 1 sample of peritoneal effusion or peritoneal lavage fluid and 1 sample of bile, in case of cholecystectomy.

Collection of samples

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years old
  • Patient COVID-19 diagnosed by positive RT-PCR SARS-CoV-2 for less than 10 days, or by thorax CT-scan suggesting specificdiagnostic aspects of COVID-19 requiring abdominal or gynecological surgery by emergency laparoscopy
  • Patient COVID-19 suspected requiring abdominal or gynecological surgery by emergency laparoscopy. Suspicion will be defined by the presence of at least one of the following symptoms:
  • Cough for less than 15 days
  • Fever which appeared recently and which excluded another etiology
  • Anosmia without obstructive rhinitis
  • Contact with a COVID-19 + case person less than 21 days ago
  • Patient requiring abdominal or gynecological surgery by emergency laparoscopy and who should be tested by RT-PCR SARS-CoV-2
  • Patients with affiliation to French social security system

You may not qualify if:

  • Patient already participating in research involving the human person
  • Negative RT-PCR SARS-CoV-2
  • Withdrawal of patient or guardian or family; or refusal to sign the required inform consent form to continue to participate in the Clinical Trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CH Victor Dupouy

Argenteuil, 95107, France

Location

CH Intercommunal

Créteil, 94000, France

Location

Department of General and Digestive Surgery, Hospital René Dubos

Pontoise, 95300, France

Location

Department of Gynecology-Obstetrics, Hospital René Dubos

Pontoise, 95300, France

Location

CH Delafontaine

Saint-Denis, 93200, France

Location

MeSH Terms

Conditions

Coronavirus InfectionsPneumoperitoneumCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPeritoneal DiseasesDigestive System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nelson Trelles

    Hôpital NOVO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2020

First Posted

April 24, 2020

Study Start

June 16, 2020

Primary Completion

December 16, 2021

Study Completion

January 18, 2022

Last Updated

September 19, 2024

Record last verified: 2022-05

Locations

FR(5)