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

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

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

August 2021