NCT04995380

Validation and Comparison of Scores for Prediction of RIsk for Post-operative Major Morbidity After Cholecystectomy in Acute Calculous Cholecystitis (SPRIMACC)

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,261 (actual)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Cholecystitis

Interventions

Type	Name	Description
PROCEDURE	Early Cholecystectomy	Cholecystectomy performed within 10 days from onset of symptoms

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2021-08-06
• Last updated: 2022-12-12

Locations

2 sites across 2 countries: Italy, Spain