Evidence map›Paper›PMID 36934276›Full record

Observational studyWorld journal of emergency surgery : WJES2023

Prediction of morbidity and mortality after early cholecystectomy for acute calculous cholecystitis: results of the S.P.Ri.M.A.C.C. study.

Paola Fugazzola, Lorenzo Cobianchi, Marcello Di Martino, Matteo Tomasoni, Francesca Dal Mas, Fikri M Abu-Zidan, Vanni Agnoletti, Marco Ceresoli, Federico Coccolini, Salomone Di Saverio and 19 more

Registry-linked trialOpen access · goldFull text readObservational StudyMulticenter Study
In one paragraph

Observational study in World journal of emergency surgery : WJES, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04995380 (Validation and Comparison of Scores for Prediction of RIsk for Post-operative Major Morbidity After Cholecystectomy in Acute Calculous Cholecystitis), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
5.9field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04995380 completednot on this map

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)

TypeobservationalSponsorFondazione IRCCS Policlinico San Matteo di PaviaRan2021 to 2022Enrolled1,261ConditionsAcute CholecystitisArmsEarly Cholecystectomy
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors at 14 institutions in 5 countries.

Paola FugazzolaDivision of General Surgery, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Lorenzo CobianchiDivision of General Surgery, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. lorenzo.cobianchi@unipv.it.
Marcello Di MartinoHepato-Biliary and Liver Transplantation Department, AORN Cardarelli, Napoli, Italy.
Matteo TomasoniDivision of General Surgery, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Francesca Dal MasDepartment of Management, Ca' Foscari University of Venice, Venice, Italy.
Fikri M Abu-ZidanThe Research Office, College of Medicine and Health Sciences, United Arab Emirates University, Al-Ain, United Arab Emirates.
Vanni AgnolettiIntensive Care Unit, Bufalini Hospital, Cesena, Italy.
Marco CeresoliGeneral and Emergency Surgery, School of Medicine and Surgery, Milano-Bicocca University, Monza, Italy.
Federico CoccoliniDepartment of Emergency and Trauma Surgery, Pisa University Hospital, University of Pisa, Pisa, Italy.
Salomone Di SaverioDepartment of Surgery, Madonna Del Soccorso Hospital, San Benedetto del Tronto, Italy.
Tommaso DominioniDivision of General Surgery, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Camilla Nikita FarèDivision of General Surgery, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Simone FrassiniDivision of General Surgery, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Giulia GambiniUnit of Clinical Epidemiology and Biometry, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Ari LeppäniemiAbdominal Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Marcello MaestriDivision of General Surgery, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Elena Martín-PérezDepartment of General and Digestive Surgery, Hospital Universitario La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid (UAM), Madrid, Spain.
Ernest E MooreDenver Health System - Denver Health Medical Center, Denver, USA.
Valeria MusellaUnit of Clinical Epidemiology and Biometry, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Andrew B PeitzmanDepartment of Surgery, University of Pittsburgh School of Medicine, UPMC-Presbyterian, Pittsburgh, USA.
Ángela de la Hoz RodríguezDepartment of General and Digestive Surgery, Hospital Universitario La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid (UAM), Madrid, Spain.
Benedetta SargentiDivision of General Surgery, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Massimo SartelliDepartment of Surgery, Macerata Hospital, 62100, Macerata, Italy.
Jacopo ViganòDivision of General Surgery, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Andrea AnderloniGastroenterology and Digestive Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Walter BifflDivision of Trauma/Acute Care Surgery, Scripps Clinic Medical Group, La Jolla, CA, USA.
Fausto CatenaGeneral and Emergency Surgery, Bufalini Hospital, Cesena, Italy.
Luca AnsaloniDivision of General Surgery, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
S.P.Ri.M.A.C.C. Collaborative Group
Policlinico San Matteo Fondazione · ITUniversity of Pavia · ITHospital Universitario de La Princesa · ESUniversity of Milano-Bicocca · ITOspedale “M. Bufalini” di Cesena · ITUniversity of Pisa · ITCa' Foscari University of Venice · ITDenver Health Medical Center · USOspedale Antonio Cardarelli · ITOspedale di MacerataScripps Clinic Medical Group · USUnited Arab Emirates University · AEUniversity of Helsinki · FIUniversity of Pittsburgh · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLess invasive alternatives than early cholecystectomy (EC) for acute calculous cholecystitis (ACC) treatment have been spreading in recent years. We still lack a reliable tool to select high-risk patients who could benefit from these alternatives. Our study aimed to prospectively validate the Chole-risk score in predicting postoperative complications in patients undergoing EC for ACC compared with other preoperative risk prediction models.

methodThe S.P.Ri.M.A.C.C. study is a World Society of Emergency Surgery prospective multicenter observational study. From 1st September 2021 to 1st September 2022, 1253 consecutive patients admitted in 79 centers were included. The inclusion criteria were a diagnosis of ACC and to be a candidate for EC. A Cochran-Armitage test of the trend was run to determine whether a linear correlation existed between the Chole-risk score and a complicated postoperative course. To assess the accuracy of the analyzed prediction models-POSSUM Physiological Score (PS), modified Frailty Index, Charlson Comorbidity Index, American Society of Anesthesiologist score (ASA), APACHE II score, and ACC severity grade-receiver operating characteristic (ROC) curves were generated. The area under the ROC curve (AUC) was used to compare the diagnostic abilities.

resultsA 30-day major morbidity of 6.6% and 30-day mortality of 1.1% were found. Chole-risk was validated, but POSSUM PS was the best risk prediction model for a complicated course after EC for ACC (in-hospital mortality: AUC 0.94, p < 0.001; 30-day mortality: AUC 0.94, p < 0.001; in-hospital major morbidity: AUC 0.73, p < 0.001; 30-day major morbidity: AUC 0.70, p < 0.001). POSSUM PS with a cutoff of 25 (defined in our study as a 'Chole-POSSUM' score) was then validated in a separate cohort of patients. It showed a 100% sensitivity and a 100% negative predictive value for mortality and a 96-97% negative predictive value for major complications.

conclusionsThe Chole-risk score was externally validated, but the CHOLE-POSSUM stands as a more accurate prediction model. CHOLE-POSSUM is a reliable tool to stratify patients with ACC into a low-risk group that may represent a safe EC candidate, and a high-risk group, where new minimally invasive endoscopic techniques may find the most useful field of action.

trial registrationClinicalTrial.gov NCT04995380.

Indexed as

CholecystectomyCholecystitisHumansMorbidityProspective StudiesRisk AssessmentAcute cholecystitisCholecystectomyPOSSUMSurgical risk

Identifiers

PMID36934276
PMCPMC10024826
OpenAlexW4327857410

What OpenQuestion holds

Textfull text, public
LicenceCC BY
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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.