An observational study in Aneurysms, Arteriovenous Malformations and Cavernomas, sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. Recruiting at 27 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Observational
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).
381 studies on the registry are indexed under Aneurysm; 78 are open to participants now.
This study's planned enrollment of 4,500 is above the median of 157 across 132 observational studies indexed under Aneurysm.
Browse Aneurysm studies →Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta is the lead sponsor of 84 studies on the registry; 32 are open to participants now.
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Patients older than 18 years old, with neurosurgical pathology
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Exclusion Criteria:
Collect data
Collect and describe the pre- and postoperative clinical status in various neurosurgical pathologies.
Time frame: 5 years
Collection data
Collect and describe the pre- and postoperative cognitive status in various neurosurgical pathologies.
Time frame: 5 years
Collection data
Collect and describe the pre- and postoperative psychological status in various neurosurgical pathologies.
Time frame: 5 years
Identify Predictors
Identify outcome predictors.
Time frame: 1 year
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Plan to share: No
Started Dec 2022 (actual). Primary completion is estimated for Jun 2027, 54 months after the start.
Of 69 observational studies under Aneurysm, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 67. This study's planned 54 months is above that.
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta