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

Acute Cholecystitis Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04995380
• Other study ID #: 20210057631
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: December 2022
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1261
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute

Intervention

Procedure:
• Early Cholecystectomy
Cholecystectomy performed within 10 days from onset of symptoms

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Countries where clinical trial is conducted

Italy,  Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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