Risk Factors for Necrotic Cholecystitis During COVID-19 Pandemic.

NCT04542512 | Unknown DMC

• 1 other identifier: 06012020
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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 and their management.

Conditions

Cholecystitis, Acute; Cholecystitis; Gangrenous; Cholecystitis Suppurative; Covid19

Keywords

COVID-19; emergency surgery; acute abdomen; peritonitis; cholecystitis; necrotic cholecystitis; percutaneous drainage of gallbladder; laparoscopic cholecystectomy; operative management; timing of cholecystectomy

Outcome Measures

Primary Outcomes (3)

• Correlation between COVID-19 pneumonia and necrotic cholecystitis

  Incidence of necrotic cholecystitis in COVID-19 patients

  through study completion, an average of 1 year

• Correlation between coagulopathy and necrotic cholecystitis

  mortality related to necrotising cholecystitis in COVID-19 patients

  through study completion, an average of 1 year

• Outcome necrotic cholecystitis during COVID-19 pandemic

  overall mortality

  through study completion, an average of 1 year

Secondary Outcomes (6)

• Correlation between coagulopathy and necrotic cholecystitis

  through study completion, an average of 1 year

• Risk factors for necrotic cholecystitis

  through study completion, an average of 1 year

• Correlation between coagulopathy and necrotic cholecystitis

  through study completion, an average of 1 year

• Correlation between coagulopathy and necrotic cholecystitis

  through study completion, an average of 1 year

• Correlation between coagulopathy and necrotic cholecystitis

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• Patients presenting with acute cholecystitis aged \<18 yo

Sponsors & Collaborators

• Poissy-Saint Germain Hospital: lead
• World Society of Emergency Surgery: collaborator
• Intercontinental society of Natural Orifice, Endoscopic, and Laparoscopic Surgery: collaborator

Study Sites (1)

Centre Hospitalier Intercommunal Poissy-Saint Germain en Laye

Poissy, 73082, France

RECRUITING

Related Publications (10)

• Eldar S, Eitan A, Bickel A, Sabo E, Cohen A, Abrahamson J, Matter I. The impact of patient delay and physician delay on the outcome of laparoscopic cholecystectomy for acute cholecystitis. Am J Surg. 1999 Oct;178(4):303-7. doi: 10.1016/s0002-9610(99)00172-5.

  PMID: 10587188 BACKGROUND

• Ying M, Lu B, Pan J, Lu G, Zhou S, Wang D, Li L, Shen J, Shu J; From the COVID-19 Investigating and Research Team. COVID-19 with acute cholecystitis: a case report. BMC Infect Dis. 2020 Jun 22;20(1):437. doi: 10.1186/s12879-020-05164-7.

  PMID: 32571224 BACKGROUND

• Bruni A, Garofalo E, Zuccala V, Curro G, Torti C, Navarra G, De Sarro G, Navalesi P, Longhini F, Ammendola M. Histopathological findings in a COVID-19 patient affected by ischemic gangrenous cholecystitis. World J Emerg Surg. 2020 Jul 2;15(1):43. doi: 10.1186/s13017-020-00320-5.

  PMID: 32615987 BACKGROUND

• Campanile FC, Podda M, Arezzo A, Botteri E, Sartori A, Guerrieri M, Cassinotti E, Muttillo I, Pisano M, Brachet Contul R, D'Ambrosio G, Cuccurullo D, Bergamini C, Allaix ME, Caracino V, Petz WL, Milone M, Silecchia G, Anania G, Agrusa A, Di Saverio S, Casarano S, Cicala C, Narilli P, Federici S, Carlini M, Paganini A, Bianchi PP, Salaj A, Mazzari A, Meniconi RL, Puzziello A, Terrosu G, De Simone B, Coccolini F, Catena F, Agresta F. Acute cholecystitis during COVID-19 pandemic: a multisocietary position statement. World J Emerg Surg. 2020 Jun 8;15(1):38. doi: 10.1186/s13017-020-00317-0.

  PMID: 32513287 BACKGROUND

• Bourikian S, Anand RJ, Aboutanos M, Wolfe LG, Ferrada P. Risk factors for acute gangrenous cholecystitis in emergency general surgery patients. Am J Surg. 2015 Oct;210(4):730-3. doi: 10.1016/j.amjsurg.2015.05.003. Epub 2015 Jun 27.

  PMID: 26186803 RESULT

• Onder A, Kapan M, Ulger BV, Oguz A, Turkoglu A, Uslukaya O. Gangrenous cholecystitis: mortality and risk factors. Int Surg. 2015 Feb;100(2):254-60. doi: 10.9738/INTSURG-D-13-00222.1.

  PMID: 25692427 RESULT

• Gomes CA, Soares C, Di Saverio S, Sartelli M, de Souza Silva PG, Orlandi AS, Heringer TL, Gomes FC, Catena F. Gangrenous cholecystitis in male patients: A study of prevalence and predictive risk factors. Ann Hepatobiliary Pancreat Surg. 2019 Feb;23(1):34-40. doi: 10.14701/ahbps.2019.23.1.34. Epub 2019 Feb 28.

  PMID: 30863805 RESULT

• Contini S, Corradi D, Busi N, Alessandri L, Pezzarossa A, Scarpignato C. Can gangrenous cholecystitis be prevented?: a plea against a "wait and see" attitude. J Clin Gastroenterol. 2004 Sep;38(8):710-6. doi: 10.1097/01.mcg.0000135898.68155.88.

  PMID: 15319657 RESULT

• Pisano M, Ceresoli M, Cimbanassi S, Gurusamy K, Coccolini F, Borzellino G, Costa G, Allievi N, Amato B, Boerma D, Calcagno P, Campanati L, Campanile FC, Casati A, Chiara O, Crucitti A, di Saverio S, Filauro M, Gabrielli F, Guttadauro A, Kluger Y, Magnone S, Merli C, Poiasina E, Puzziello A, Sartelli M, Catena F, Ansaloni L. 2017 WSES and SICG guidelines on acute calcolous cholecystitis in elderly population. World J Emerg Surg. 2019 Mar 4;14:10. doi: 10.1186/s13017-019-0224-7. eCollection 2019.

  PMID: 30867674 RESULT

• Hunt DR, Chu FC. Gangrenous cholecystitis in the laparoscopic era. Aust N Z J Surg. 2000 Jun;70(6):428-30. doi: 10.1046/j.1440-1622.2000.01851.x.

  PMID: 10843398 RESULT

Related Links

• Registration form to collaborate
• Online case report form

MeSH Terms

Conditions

Cholecystitis, Acute; Cholecystitis; Gangrene; COVID-19; Abdomen, Acute; Peritonitis

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive; Intraabdominal Infections; Peritoneal Diseases

Central Study Contacts

Belinda De Simone, MD

CONTACT

+33665787872; desimone.belinda@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgeon

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: September 9, 2020
• Study Start: October 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: December 1, 2021
• Last Updated: March 26, 2021

Record last verified: 2021-03

Locations

FR (1)