Brief Title
Validation and Comparison of Scores for Prediction of RIsk for Post-operative Major Morbidity After Cholecystectomy in Acute Calculous Cholecystitis (SPRIMACC)
Official 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)
Brief 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.
Study Type
Observational
Primary Outcome
Complicated post-operative course
Condition
Acute Cholecystitis
Intervention
Early Cholecystectomy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
663
Start Date
September 1, 2021
Completion Date
February 28, 2023
Primary Completion Date
February 28, 2023
Eligibility Criteria
Inclusion Criteria: - have a diagnosis of Acute Calculous Cholecystitis (ACC) as defined by Tokyo Guidelines 2018 criteria - be candidate to Early Cholecystectomy (EC) during the index admission* - be ≥ 18 years old - be stratified for the risk of Common Bile Duct Stones (CBDS) according to the Israelian Score, and, in case of confirmation of CBDS receive pre-operative Endoscopic Retrograde Cholangiopancreatography (ERCP). - provide signed and dated informed consent form - willing to comply with all study procedures and be available for the duration of the study. - All the patients treated with initial open cholecystectomy, those who undergo Early Laparoscopic Cholecystectomy (ELC), those with conversion from laparoscopic to open cholecystectomy or those who undergo bail out procedures (e.g. subtotal cholecystectomy) will be included. Exclusion Criteria: - pregnancy or lactation - acute cholecystitis not related to a gallstone etiology - onset of symptoms >10 days before cholecystectomy** - concomitant cholangitis or 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. - 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Paola Fugazzola, +390382252579, [email protected]
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT04995380
Organization ID
20210057631
Responsible Party
Principal Investigator
Study Sponsor
IRCCS Policlinico S. Matteo
Study Sponsor
Paola Fugazzola, Principal Investigator, Fondazione IRCCS Policlinico San Matteo
Verification Date
October 2021