An observational study in Acute Cholecystitis, sponsored by Hospital del Mar. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Hospital del Mar · Observational
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.
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.
266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 200 across 90 observational studies indexed under Cholecystitis.
Browse Cholecystitis studies →Hospital del Mar is the lead sponsor of 45 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All the consecutive admisions with an acute calculous cholecystitis, independent on the treatment indicated, during 2025 and 2026.
Exclusion Criteria:
Mortality
Describe the mortality in the cohort and its causes
Time frame: Jan 2025- Dec 2026
Complications
Describe the mortality in the cohort by Clavien-Dindo's classification
Time frame: Jan 2025- Dec 2026
ACME's prediction of mortality
To describe the prediction in a ROC Curve of ACME Scoring System with C-Statistic
Time frame: Jan 2025- Dec 2026
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Hospital del Mar