External Validation os the ACME Scoring System

NCT ID: NCT06228027

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-04-15

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.

Conditions

Acute Cholecystitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Acute Calculous Cholecystitis

Exclusion Criteria

• Acute Cholangitis
• Chronic Cholecystitis
• Neoplasia
• Acute Pancreatitis
• Pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital del Mar

OTHER

Sponsor Role: lead

Responsible Party

Ana María González Castillo

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana María González Castillo, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Mar

Central Contacts

Ana María González Castillo, PhD

Role: CONTACT

amgonzalezcastillo@gmail.com

+34665126866

Other Identifiers

External_ACME Validation

Identifier Type: -

Identifier Source: org_study_id