The SPRIMACC study is a prospective multicenter observational study with the primary endpoint to prospectively validate the Chole-Risk score in predicting a complicated postoperative course (post-operative major complications (Clavien-Dindo\>=3a), length of stay (LOS) \> 10 days or need of readmission within 30 days from the discharge) in patients undergoing Early Cholecystectomy (EC) for Acute Calculous Cholecystitis (ACC). The secondary endpoints of the study are to prospectively validate and compare other wellknown 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 a complicated post-operative course in patients undergoing EC.
Study Type
OBSERVATIONAL
Enrollment
1,261
Cholecystectomy performed within 10 days from onset of symptoms
Chirurgia 1, Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Department of General and Digestive Surgery Hospital Universitario La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) Universidad Autónoma de Madrid (UAM),
Madrid, Spain
Complicated post-operative course
The study outcome is a composite outcome including: 1. 30-day post-operative major morbidity, intended as Clavien-Dindo \>= 3a complication 2. length of stay (LOS) \> 10 days 3. readmission within 30 days from the discharge after Early Cholecystectomy for Acute Calculous Cholecystis. It is a binary outcome (0/1): in the event of a, b or c occurring, the patient's course is defined as complicated (1). If neither a, b, nor c occur, the course is defined as uncomplicated (0).
Time frame: 30 days after discharge
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