Prediction of the Mortality in Acute Calculous Cholecystitis. The ACME Project.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10,000
- 主要终点
- Mortality
研究概览
简要总结
Acute calculous cholecystitis (ACC) is the second most frequent surgical condition in emergency departments. The recommended treatment is surgical treatment (ST) and the accepted mortality is <1%, but in severe and/or fragile patients is higher. Despite the Tokyo Guidelines, there no consensus on who is the unfit patient for ST. A recent study has identified 4 risk factors that predicts the mortality in a 92% of patients (ACME) and could help to develop new guidelines in ACC. The aim of this study is to perfom an external validation of the new simplified scoring system for mortality in ACC.
详细描述
This is a prospective multicenter observational study of 10.000 adults with ACC during 2 consecutive years (2025/2026), including baseline demographic characteristics, comorbidity severity defined as Charlson Comorbidity Index (CCI), ASA Score, Tokyo Guidelines severity classification and the new ACME Scoring system. The primary outcome is to study the prediction of mortality of ACME score. Secondary outcomes include complications following Clavien-Dindo's classification, C-statistic, and ROC Curves.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute Calculous Cholecystitis
排除标准
- •Acute Cholangitis
- •Chronic Cholecystitis
- •Neoplasia
- •Acute Pancreatitis
结局指标
主要结局
Mortality
时间窗: Jan 2025- Dec 2026
Describe the mortality in the cohort and its causes
Complications
时间窗: Jan 2025- Dec 2026
Describe the mortality in the cohort by Clavien-Dindo's classification
ACME's prediction of mortality
时间窗: Jan 2025- Dec 2026
To describe the prediction in a ROC Curve of ACME Scoring System with C-Statistic
次要结局
未报告次要终点
研究者
Ana María González Castillo
Doctor
Hospital del Mar