NCT06228027

External Validation os the ACME Scoring System

Prediction of the Mortality in Acute Calculous Cholecystitis. The ACME Project.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Hospital del Mar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Cholecystitis

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-01-01
• Completion: 2027-04-15
• First posted: 2024-01-29
• Last updated: 2024-03-12