CHOLE-POSSUM PRO Validation for Prediction of Mortality After Cholecystectomy for Acute Calculous Cholecystitis: Protocol for a Prospective Multicenter Observational Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-10-11

Brief Summary

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CHOLE-POSSUM PRO is a prospective multicenter observational study on patients with ACC candidate to EC. The rationale of the study is to validate the CHOLE-POSSUM PRO SCORE for 30-day mortality in this population.

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Detailed Description

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Conditions

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Acute Calculous Cholecystitis Candidate to Early Cholecystectomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients who receive a diagnosis of ACC as defined by TG18 criteria and with ACC

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* have a diagnosis of ACC as defined by TG18 criteria
* be ACC candidate to EC during the index admission\* (\* All the patients treated with initial open cholecystectomy, those who undergo ELC, those with conversion from laparoscopic to open cholecystectomy or those who undergo bail out procedures (e.g. subtotal cholecystectomy) will be included.)
* be ≥ 18 years old
* be stratified for the risk of CBDS according to the Israelian Score (29), and, in case of confirmation of CBDS receive pre-operative ERCP
* provide signed and dated informed consent form
* willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria

* pregnancy or lactation
* acute cholecystitis not related to a gallstone etiology
* onset of symptoms \>10 days before cholecystectomy\*\* (\*\* Patients with ACC associated with common bile duct stones who underwent pre-operative ERCP could be included if they receive EC within 10 days from onset of symptoms)
* concomitant pancreatitis
* intraoperative treatment of common bile duct stones
* anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No