Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06213740
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2024-01-10
Brief Title:
Validation of a New Simplified Scoring System for Acute Calculous Cholecystitis
Sponsor:
Hospital del Mar
Organization:
Hospital del Mar
Study Overview
Official Title:
Validation of a New Simplified Scoring System ACME for Acute Calculous Cholecystitis
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACME
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 andor 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 20172021 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-Dindos classification C-statistic and ROC Curves
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None