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Neurosurgical Outcome Network Per La Predizione Dell'outcome in Neurochirurgia
The evaluation of neurosurgical outcomes varies from center to center, and the predictive factors that determine these outcomes are not fully known or shared. This study aims to assess outcomes and their predictors using measures agreed upon by the participating centers. Standardizing the evaluation of outcomes and predictors improves the quality of research, allows for data comparison, and facilitates a "common language" in routine clinical practice. Most importantly, it influences therapeutic decisions in various neurosurgical conditions. Clinically, the identified predictors can also be used during preoperative assessments to provide more precise guidance to patients undergoing surgery.
The evaluation of outcome indicators, quality of life, and complexity in Neurosurgery has gained significant importance not only at a clinical and therapeutic level but also as a tool to assess the effectiveness and efficiency of the healthcare system. This study aims to evaluate neurosurgical outcomes and their predictors using measures shared among participating centers. Such evaluation varies from center to center, and the predictive factors are not entirely known or shared. Standardizing the evaluation of outcomes and predictors improves research quality, enables data comparison, and fosters a common language in everyday clinical practice. Most importantly, it influences therapeutic decisions in various neurosurgical pathologies. Primary Objective: Collect and describe the pre- and postoperative clinical, cognitive, and psychological status in various neurosurgical pathologies. Secondary Objectives: Identify outcome predictors. Primary Endpoint: Description of pre- and postoperative clinical, cognitive, and psychological data of patients undergoing neurosurgical intervention. Secondary Endpoints: Analyze the association between preoperative indicators collected and postoperative outcomes. Specific predictors and outcome measures for each neurosurgical pathology will be considered and reported in Appendix 1. Patient enrollment from Neurosurgery Departments; collection of clinical, cognitive, and psychological data before the intervention and during follow-up after the intervention (timing varies depending on the neurosurgical pathology); data analysis through AI. For all neurosurgical pathologies, the following data will be collected: sociodemographic, clinical (Charlson Comorbidity Index, heart disease, diabetes, Chronic Obstructive Pulmonary Disease, hypertension, Body Mass Index, smoking, psychiatric pathology, admission date, intervention date, discharge date, Modified Rankin Scale, American Society of Anesthesiologists, weight, height), anesthesiological (collected only by FINCB), and complication-related data (Novel Therapy-Disability-Neurology).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
1. ASST Papa Giovanni XXIII
Bergamo, BG, Italy
Spedali Civili Brescia
Brescia, BS, Italy
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, BS, Italy
Ospedale Moriggia Pelascini
Gravedona, Como, Italy
ASST Lariana, Ospedale S. Anna
Como, CO, Italy
ASST Cremona
Cremona, CR, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, MB, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, Italy
ASST della Valtellina ed Alto Lario
Sondrio, SO, Italy
Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
Catania, Italy
Start Date
December 5, 2022
Primary Completion Date
June 1, 2027
Completion Date
June 1, 2027
Last Updated
December 19, 2024
4,500
ESTIMATED participants
Lead Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02879071