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临床试验/NCT04542512
NCT04542512Unknown不适用

Risk Factors for Necrotic Cholecystitis During COVID-19 Pandemic: the ChoCO-WSES Prospective Observational Multicenter International Study.

Poissy-Saint Germain Hospital1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
800
试验地点
1
主要终点
Correlation between coagulopathy and necrotic cholecystitis

研究概览

简要总结

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.

详细描述

Background:

Gangrenous cholecystitis is the most common complication of acute cholecystitis affecting around 15% (range 2-30%) of patients and it occurs as a result of ischemia with necrosis of the gallbladder wall [1].

It is related to an increased mortality rate (mortality rate ranging between 15 and 50%) compared with non-necrotic acute cholecystitis[2].

Retrospective studies that investigated risk and predictive factors related to gangrenous cholecystitis showed that males, older patients with diabetes, coronary artery disease, and other comorbidities are at risk to present with gangrenous cholecystitis. [1-3] Another study identified longer delay time prior to hospital admission and low white blood cell count as independent risk factors affecting mortality and indicated the presence of diabetes mellitus, higher blood levels of aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase and total bilirubin, pericholecystic fluid in abdominal ultrasonography, and conversion from laparoscopic surgery to open surgery as risk factors increasing mortality [2] In any case, the treatment of GC is similar to that of patients with AC but in the presence of GC, cholecystectomy can be difficult because of adhesions, insufficient anatomic control, complications like bleeding, and injury to bile ducts.

There is high variability in the reported conversion rate to be 30% to 50% [4], down to 8.7% [5]. These results are probably due to a careful preoperative selection of patients for laparoscopic cholecystectomy and early surgery [6].

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Patients presenting with acute cholecystitis aged <18 yo

结局指标

主要结局

Correlation between coagulopathy and necrotic cholecystitis

时间窗: through study completion, an average of 1 year

mortality related to necrotising cholecystitis in COVID-19 patients

Outcome necrotic cholecystitis during COVID-19 pandemic

时间窗: through study completion, an average of 1 year

overall mortality

Correlation between COVID-19 pneumonia and necrotic cholecystitis

时间窗: through study completion, an average of 1 year

Incidence of necrotic cholecystitis in COVID-19 patients

次要结局

  • 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)

研究者

发起方
Poissy-Saint Germain Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Belinda De Simone

General Surgeon

Poissy-Saint Germain Hospital

研究点 (1)

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