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Risk Factors for Necrotic Cholecystitis During COVID-19 Pandemic. (ChoCO-W)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04542512
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : October 14, 2020
Sponsor:
Collaborators:
World Society of Emergency Surgery
Intercontinental society of Natural Orifice, Endoscopic, and Laparoscopic Surgery
Information provided by (Responsible Party):
Belinda De Simone, Poissy-Saint Germain Hospital

Brief Summary:

Gangrenous cholecystitis is the most common complication of acute cholecystitis.

Preliminary data showed that COVID-19 patients have a high risk to present necrotic cholecystitis.

The Cholecystitis under COVID-19 pandemic WSES (ChoCO-W) study aims to investigate risk factors and high-risk patients to develop necrotic cholecystitis during this pandemic.


Condition or disease
Cholecystitis, Acute Cholecystitis; Gangrenous Cholecystitis Suppurative Covid19

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Risk Factors for Necrotic Cholecystitis During COVID-19 Pandemic: the ChoCO-WSES Prospective Multicenter Observational Study.
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Correlation between COVID-19 pneumonia and necrotic cholecystitis [ Time Frame: through study completion, an average of 1 year ]
    Incidence of necrotic cholecystitis in COVID-19 patients

  2. Correlation between coagulopathy and necrotic cholecystitis [ Time Frame: through study completion, an average of 1 year ]
    Mean D-dimer value

  3. Correlation between coagulopathy and necrotic cholecystitis [ Time Frame: through study completion, an average of 1 year ]
    Mean INR value

  4. Correlation between coagulopathy and necrotic cholecystitis [ Time Frame: through study completion, an average of 1 year ]
    Mean Prothrombin time (PT; sec); mean activated partial thromboplastin (aPT; sec)

  5. Correlation between coagulopathy and necrotic cholecystitis [ Time Frame: through study completion, an average of 1 year ]
    Mean Fibrinogen value (g/L)

  6. Correlation between coagulopathy and necrotic cholecystitis [ Time Frame: through study completion, an average of 1 year ]
    most common alterations of thromboelastography

  7. Risk factors for necrotic cholecystitis [ Time Frame: through study completion, an average of 1 year ]
    incidence of diabetes

  8. Outcome necrotic cholecystitis [ Time Frame: through study completion, an average of 1 year ]
    overall mortality



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients admitted to the surgical department with clinical and histologic diagnosis of acute cholecystitis (with and without gangrenous cholecystitis).
Criteria

Inclusion Criteria:

All patients presenting acute cholecystitis during COVID 19 pandemic, aged >=18 yo

Exclusion Criteria:

Patients presenting with acute cholecystitis aged <18 yo


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04542512


Contacts
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Contact: Belinda De Simone, MD +33665787872 desimone.belinda@gmail.com

Locations
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France
Centre Hospitalier Intercommunal Poissy-Saint Germain en Laye Recruiting
Poissy, France, 73082
Contact: Belinda De Simone    +33665787872    desimone.belinda@gmail.com   
Principal Investigator: Elie Chouillard         
Principal Investigator: Belinda De Simone         
Sponsors and Collaborators
Poissy-Saint Germain Hospital
World Society of Emergency Surgery
Intercontinental society of Natural Orifice, Endoscopic, and Laparoscopic Surgery
Additional Information:
Publications of Results:

Other Publications:
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Responsible Party: Belinda De Simone, General Surgeon, Poissy-Saint Germain Hospital
ClinicalTrials.gov Identifier: NCT04542512    
Other Study ID Numbers: 06012020
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Belinda De Simone, Poissy-Saint Germain Hospital:
COVID-19
emergency surgery
acute abdomen
peritonitis
cholecystitis
necrotic cholecystitis
percutaneous drainage of gallbladder
Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Necrosis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Pathologic Processes