External Validation os the ACME Scoring System
- Conditions
- Acute Cholecystitis
- Registration Number
- NCT06228027
- Lead Sponsor
- Hospital del Mar
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 10000
- Acute Calculous Cholecystitis
- Acute Cholangitis
- Chronic Cholecystitis
- Neoplasia
- Acute Pancreatitis
- Pregnant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality Jan 2025- Dec 2026 Describe the mortality in the cohort and its causes
Complications Jan 2025- Dec 2026 Describe the mortality in the cohort by Clavien-Dindo's classification
ACME's prediction of mortality Jan 2025- Dec 2026 To describe the prediction in a ROC Curve of ACME Scoring System with C-Statistic
- Secondary Outcome Measures
Name Time Method