Belinda de Simone1, Fausto Catena2, Salomone Di Saverio3, Massimo Sartelli4, Fikri M. Abu-Zidan5, Mauro Podda6, Walter L Biffl7, Luca Ansaloni8, Federico Coccolini9, Ernest E Moore10, Yoram Kluger11, Carlos Augusto Gomes12, Ferdinando Agresta13, Elie Chouillard1

1Department of Emergency and Metabolic Minimally Invasive Surgery, Poissy/Saint Germain en Laye Hospitals, France
2Department of Emergency and Trauma Surgey, Bufalini Trauma Center, Cesena, Italy
3Department of General Surgery, Saint Mary of the Rescue, San Benedetto del Tronto, Italy
4Unit of General Surgery, Macerata Hospital, Macerata, Italy
5Department of Surgery, College of Medicine and Health Sciences, UAE University, Al-Ain, United Arab Emirates
6Department of Surgery, Unit of General Surgery, University Hospital of Cagliari, Cagliari, Italy
7Department of Emergency and Trauma Surgery, Scripps Memorial Hospital, La Jolla-California, United States
8Department of General Surgery, University Hospital of Pavia, Pavia, Italy
9Department of General Surgery, University Hospital of Pisa, Pisa, Italy
10Ernest E Moore Shock Trauma Center at Denver Health Medical, United States
11Division of Surgery, Rambam Health Care Campus, Haifa, Israel
12Department of Surgery, University Hospital, Juiz da Fora, Brazil
13Department of General Surgery, Adria Hospital, Adria, Italy

Abstract

Objective: During the COVID-19 pandemic, several studies have reported a decrease in in the admission surgical patients and emergency surgical procedures, and an increase in more severe septic surgical diseases, such as necrotic cholecystitis. It was probably due to to a critical delay in time-to- diagnosis and time-to-intervention resulting to limited access to the operating theatres as well as intensive care units. Early laparoscopic cholecystec- tomy is the standard of care for acute cholecystitis. Moreover early data from COVID-19 pandemic reported an increase in the incidence of necrotic cholecystitis among COVID-19 patients. The ChoCO-W prospective observational collaborative study was conceived to investigate the incidence and management of acute cholecystitis under the COVID-19 pandemic.

Material and Methods: The present research protocol was. conceived and designed as a prospective observational international collaborative study focusing on the management of patients with to the diagnosis of acute cholecystitis under the COVID-19 pandemic. The study obtained the approval of the local Ethics Committee (Nimes, France) and meet and conform to the standards outlined in the Declaration of Helsinki. Eligible patients will be prospectively enrolled in the recruitment period and data entered in an online case report form.

Results: The ChoCO-W study will be the largest prospective study carried out during the first period of the COVID-19 pandemic with the aim to inves- tigate the management of patients with acute cholecystitis, in the lack of studies focusing on COVID-19 positive patients.

Conclusion: The ChoCO-W study is conceived to be the largest prospective study to assess the management of patients presenting with acute chol- ecystitis during the COVID-19 pandemic and risk factors correlated with necrotic cholecystitis to improve the management of high-risk patients.

Keywords: Cholecystitis, management, COVID-19, SARS-CoV-2, WSES, ChoCO-W


 

Ethics Committee Approval

This study approval was obtained from Sud Mediterranee Ethics Committee, Nimes, France (03.05.2021 21.01.16.09406)

Peer Review

Externally peer-reviewed.

Author Contributions

Concept - B.D.S.; Design - B.D.S, F.C.; F.M.A.Z.; Supervision - S.D.S., F.C., E.C., B.D.S, L.A., W.L.B., F.A.; Materials - B.D.S.; Data Collection and/or Processing - B.D.S.; Analysis and/or Interpretation - B.D.S., F.M.A.Z.; Literature Search - B.D.S.; Writing Manuscript - B.D.S.; Critical Reviews - All of authors.

Conflict of Interest

The authors have no conflicts of interest to declare.

Financial Disclosure

The authors declared that this study has received no financial support.

Acknowledgments

The World Society of Emergency Surgery (WSES) and the Italian Society of Endoscopic Surgery (SICE) for having contributed to the diffusion of the study.
The ChoCO-W collaborative group for the collaboration and scientific contribution.
Many thanks to Professors Fausto Catena, Elie Chouillard and Andrew Gumbs.
Thanks to all ChoCO collaborators for their efforts during this pandemic.