Validation of a New Simplified Scoring System for Acute Calculous Cholecystitis

NCT06213740 | Completed

• 1 other identifier: ACME_Validation
• Study Type: observational
• Target: 387
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cholecystitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mortality

  Evaluate the mortality in the cohort

  2017 and 2021

Secondary Outcomes (1)

• Complications

  2017 and 2021

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All the admisions with the inclusion criteria during 2017 and 2021.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital del Mar: lead

Study Sites (1)

Ana María González Castillo

Cerdanyola del Vallès, Barcelona, 08290, Spain

Location

MeSH Terms

Conditions

Cholecystitis, Acute; Postoperative Complications

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 19, 2024
• Study Start: January 8, 2021
• Primary Completion: May 1, 2021
• Study Completion: December 17, 2021
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

ES (1)