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

NCT ID: NCT04995380

Last Updated: 2022-12-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1261 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-10-01

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.

Conditions

Acute Cholecystitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Early Cholecystectomy

Cholecystectomy performed within 10 days from onset of symptoms

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Paola Fugazzola

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paola Fugazzola

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Policlinico San Matteo

Locations

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

Countries

Italy; Spain

References

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.

Reference Type: BACKGROUND

PMID: 33629230 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36934276 (View on PubMed)

Other Identifiers

20210057631

Identifier Type: -

Identifier Source: org_study_id