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

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)

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 Overview

• Status: Completed
• Conditions: Acute Cholecystitis
• Intervention / Treatment: Procedure: Early Cholecystectomy

• Study Type: Observational
• Enrollment (Actual): 1261

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Chirurgia 1, Fondazione IRCCS Policlinico San Matteo
• Spain
  • Madrid, Spain
    • Department of General and Digestive Surgery Hospital Universitario La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) Universidad Autónoma de Madrid (UAM),

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complicated post-operative course	The study outcome is a composite outcome including: 30-day post-operative major morbidity, intended as Clavien-Dindo >= 3a complication; length of stay (LOS) > 10 days; readmission within 30 days from the discharge 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

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Matteo
• Investigators: Principal Investigator: Paola Fugazzola, Fondazione IRCCS Policlinico San Matteo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: 20210057631

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No