Clinical trial NCT04995380: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Cholecystitis
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 1261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


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

Primary outcomes:
measure: Complicated post-operative course
timeFrame: 30 days after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Chirurgia 1, Fondazione IRCCS Policlinico San Matteo
city: Madrid
country: Spain
facility: Department of General and Digestive Surgery Hospital Universitario La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) Universidad Autónoma de Madrid (UAM),
Study officials:
affiliation: Fondazione IRCCS Policlinico San Matteo
name: Paola Fugazzola
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.