Validation of a New Simplified Scoring System for Acute Calculous Cholecystitis

Validation of a New Simplified Scoring System (ACME) for Acute Calculous Cholecystitis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06213740

Acronym

ACME

Enrollment

387

Registered

2024-01-19

Start date

2021-01-08

Completion date

2021-12-17

Last updated

2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Cholecystitis

Keywords

Acute Cholecystitis, Cholecystectomy, Tokyo Guidelines, Postoperative Complications, Mortality, High-risk patient

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 this validation of the new simplified scoring system for mortality in ACC.

Detailed description

This is a retrospective single-center observational study of 387 adults with ACC during 2 non-consecutive years (2017/2021), including baseline demographic characteristics, comorbidity severity defined as Charlson Comorbidity Index (CCI), ASA Score, Tokyo Guidelines' severity classification and the new ACME Score. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* The selected patients were among those who had acute cholecystitis according to the TG18 or received a diagnosis of ACC in the histopathological report.

Exclusion criteria

* The study case definition was a Pure ACC, therefore, patients with any other concomitant diagnosis potentially influencing outcome such as acute pancreatitis, acalculous cholecystitis, chronic cholecystitis, acute cholangitis, postoperative cholecystitis, gallbladder adenocarcinoma and those who had undergone cholecystectomy as a prophylactic measure in another intervention were excluded from the study.

Design outcomes

Primary

Measure	Time frame	Description
Mortality	2017 and 2021	Evaluate the mortality in the cohort

Secondary

Measure	Time frame	Description
Complications	2017 and 2021	Clavien-Dindo

Countries

Spain

Outcome results