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

Completed

• Conditions: Acute Cholecystitis

• Registration Number: NCT04995380
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-06
• Study Start: 2021-09-01
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-09
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1261

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complicated post-operative course	30 days after discharge	The study outcome is a composite outcome including: 1. 30-day post-operative major morbidity, intended as Clavien-Dindo \>= 3a complication; 2. length of stay (LOS) \> 10 days; 3. 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).

Trial Locations

Locations (2)

Department of General and Digestive Surgery Hospital Universitario La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) Universidad Autónoma de Madrid (UAM),; 🇪🇸 Madrid, Spain

Chirurgia 1, Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy