SPRIMACC STUDY
Validation and comparison of Scores for Prediction of RIsk for post-operative major Morbidity after cholecystectomy in Acute Calculous Cholecystitis: protocol for a prospective multicenter observational study (SPRIMACC)
WHAT IS
SPRIMACC STUDY?
... in short the SPRIMACC study ...
Title:
Validation and comparison of Scores for Prediction of RIsk for post-operative major Morbidity after cholecystectomy in Acute Calculous Cholecystitis: protocol for a prospective multicenter observational study (SPRIMACC)
Précis:
Prospective multicentre observational study
Objectives:
Primary: The primary end point is to prospectively validate the Chole-Risk score in predicting the risk of 30-days post-operative major complications (Clavien-Dindo>3a) in patients undergoing Early Cholecystectomy (EC) for Acute Calculous Cholecystitis (ACC).
Secondary: The secondary end point of the study is to prospectively validate and compare the performance of other well-known risk prediction models (the POSSUM/ P-POSSUM score, the Modified Frailty Index (mFI), the Charlson Comorbidity Index (CCI), the American Society of Anesthesiologists (ASA) score and the APACHE II score) in predicting the risk of 30-days post-operative major complications (Clavien-Dindo 3a) in patients undergoing EC for ACC.
Population:
All patients presenting with ACC as defined according to the TG 2018 to one of the participating hospitals will be assessed for eligibility on presentation. The calculated sample size is 663 patients.
Study Duration:
18 months
Subject Participation Duration:
30 days
Estimated Time to Complete Enrollment:
One year