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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Cholecystectomy | Procedure | Cholecystectomy performed within 10 days from onset of symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Complicated post-operative course | The study outcome is a composite outcome including:
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). | 30 days after discharge |
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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.
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.
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All consecutive patients presenting with ACC as defined according to the Tokyo Guidelines 2018 to one of the participating hospitals will be assessed for eligibility on presentation.
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| Name | Affiliation | Role |
|---|---|---|
| Paola Fugazzola | Fondazione IRCCS Policlinico San Matteo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chirurgia 1, Fondazione IRCCS Policlinico San Matteo | Pavia | 27100 | Italy | |||
| Department of General and Digestive Surgery Hospital Universitario La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) Universidad Autónoma de Madrid (UAM), |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33629230 | Background | Di Martino M, Mora-Guzman I, Jodra VV, Dehesa AS, Garcia DM, Ruiz RC, Nisa FG, Moreno FM, Batanero SA, Sampedro JEQ, Cumplido PL, Bravo AA, Rubio-Perez I, Asensio-Gomez L, Aranda FP, Farrarons SS, Moreno CR, Moreno CMM, Lasarte AS, Calvo MP, Aparicio-Sanchez D, Del Pozo EP, Pellino G, Martin-Perez E. How to Predict Postoperative Complications After Early Laparoscopic Cholecystectomy for Acute Cholecystitis: the Chole-Risk Score. J Gastrointest Surg. 2021 Nov;25(11):2814-2822. doi: 10.1007/s11605-021-04956-9. Epub 2021 Feb 24. | |
| 36934276 |
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| Madrid |
| Spain |
| Derived |
| Fugazzola P, Cobianchi L, Di Martino M, Tomasoni M, Dal Mas F, Abu-Zidan FM, Agnoletti V, Ceresoli M, Coccolini F, Di Saverio S, Dominioni T, Fare CN, Frassini S, Gambini G, Leppaniemi A, Maestri M, Martin-Perez E, Moore EE, Musella V, Peitzman AB, de la Hoz Rodriguez A, Sargenti B, Sartelli M, Vigano J, Anderloni A, Biffl W, Catena F, Ansaloni L; S.P.Ri.M.A.C.C. Collaborative Group. Prediction of morbidity and mortality after early cholecystectomy for acute calculous cholecystitis: results of the S.P.Ri.M.A.C.C. study. World J Emerg Surg. 2023 Mar 18;18(1):20. doi: 10.1186/s13017-023-00488-6. |
| ID | Term |
|---|---|
| D041881 | Cholecystitis, Acute |
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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