Risk Factors for Necrotic Cholecystitis During COVID-19 Pandemic: the ChoCO-WSES Prospective Observational Multicenter International Study.
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
- 否
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
Belinda De Simone
General Surgeon
Poissy-Saint Germain Hospital
