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

Launched by FONDAZIONE IRCCS POLICLINICO SAN MATTEO DI PAVIA · Apr 1, 2025

Keywords

ClinConnect Summary

The CHOLE-POSSUM PRO study is looking at patients who have acute calculous cholecystitis, a condition where gallstones cause inflammation of the gallbladder, and who are candidates for early surgery to remove the gallbladder. The main goal of this research is to test a scoring system called the CHOLE-POSSUM PRO SCORE, which helps predict the risk of death within 30 days after surgery for these patients. This study is currently recruiting participants aged 18 and older who meet specific criteria, such as having a confirmed diagnosis of this condition and being eligible for surgery during their hospital stay.

If you or a loved one are considering joining this study, you will need to provide consent and be available for the entire duration of the research. Participants may also undergo some evaluations to assess their risk before surgery. It's important to note that some individuals, such as pregnant women or those with certain other health conditions, will not be eligible to participate. This study aims to improve the care and outcomes for patients undergoing surgery for gallbladder issues, helping doctors make better decisions based on the risk factors involved.

Gender

ALL

Eligibility criteria

• 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.