Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Collect data | Collect and describe the pre- and postoperative clinical status in various neurosurgical pathologies. | 5 years |
| Collection data | Collect and describe the pre- and postoperative cognitive status in various neurosurgical pathologies. | 5 years |
| Collection data | Collect and describe the pre- and postoperative psychological status in various neurosurgical pathologies. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Identify Predictors | Identify outcome predictors. | 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients older than 18 years old, with neurosurgical pathology
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paolo Ferroli, MD | Contact | +39 02 2394 2411 | 2411 | paolo.ferroli@istituto-besta.it |
| Morgan A Broggi, MD | Contact | +39 02 2394 2411 | 2411 | morgan.broggi@istituto-besta.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1. ASST Papa Giovanni XXIII | Active, not recruiting | Bergamo | BG | 24127 | Italy | |
| Spedali Civili Brescia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33887774 | Background | Terrapon APR, Zattra CM, Voglis S, Velz J, Vasella F, Akeret K, Held U, Schiavolin S, Bozinov O, Ferroli P, Broggi M, Sarnthein J, Regli L, Neidert MC. Adverse Events in Neurosurgery: The Novel Therapy-Disability-Neurology Grade. Neurosurgery. 2021 Jul 15;89(2):236-245. doi: 10.1093/neuros/nyab121. | |
| 13432835 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Active, not recruiting |
| Brescia |
| BS |
| 25123 |
| Italy |
| Fondazione Poliambulanza Istituto Ospedaliero | Active, not recruiting | Brescia | BS | 25124 | Italy |
| Ospedale Moriggia Pelascini | Active, not recruiting | Gravedona | Como | 22015 | Italy |
| ASST Lariana, Ospedale S. Anna | Active, not recruiting | Como | CO | 22100 | Italy |
| ASST Cremona | Active, not recruiting | Cremona | CR | 26100 | Italy |
| Fondazione IRCCS San Gerardo dei Tintori | Active, not recruiting | Monza | MB | 20900 | Italy |
| Fondazione IRCCS Policlinico San Matteo | Active, not recruiting | Pavia | PV | 27100 | Italy |
| ASST della Valtellina ed Alto Lario | Active, not recruiting | Sondrio | SO | 23100 | Italy |
| Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" | Recruiting | Catania | Italy |
|
| Azienda Ospedaliero Universitaria Careggi | Recruiting | Florence | Italy |
|
| Ospedale F. Spaziani di Frosinone | Recruiting | Frosinone | 03100 | Italy |
|
| Ospedale Alessandro Manzoni | Active, not recruiting | Lecco | 23900 | Italy |
| ASST Ovest Milanese | Active, not recruiting | Legnano | 20025 | Italy |
| Ospedali Riuniti di Livorno -Azienda USL Toscana nord ovest | Recruiting | Livorno | Italy |
|
| Fondazione IRCCS Istituto Neurologico Carlo Besta | Recruiting | Milan | 20133 | Italy |
|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Active, not recruiting | Milan | 20122 | Italy |
| ASST Santi Paolo e Carlo | Recruiting | Milan | 20153 | Italy |
|
| ASST Fatebenefratelli Sacco | Active, not recruiting | Milan | Italy |
| Istituto Clinico Città Studi | Active, not recruiting | Milan | Italy |
| Policlinico di Monza | Recruiting | Monza | 20900 | Italy |
|
| A.R.N.A.S. Ospedali Civico di Palermo | Recruiting | Palermo | 90127 | Italy |
|
| Azienda Ospedaliero Universitaria di Parma | Active, not recruiting | Parma | Italy |
| ASL Roma 1 | Recruiting | Roma | 00135 | Italy |
|
| Fondazione Policlinico Universitario Gemelli di Roma | Recruiting | Roma | 00168 | Italy |
|
| IRCCS Istituto Clinico Humanitas | Active, not recruiting | Rozzano | 20089 | Italy |
| Azienda Sanitaria Universitaria Friuli Centrale di Udine | Recruiting | Udine | 33100 | Italy |
|
| RANKIN J. Cerebral vascular accidents in patients over the age of 60. II. Prognosis. Scott Med J. 1957 May;2(5):200-15. doi: 10.1177/003693305700200504. No abstract available. |
| 3558716 | Background | Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8. |
| 22371630 | Background | Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012 Jun;9(3):322-9. doi: 10.1177/1740774512438980. Epub 2012 Feb 27. |
| 21314270 | Background | Jakola AS, Unsgard G, Solheim O. Quality of life in patients with intracranial gliomas: the impact of modern image-guided surgery. J Neurosurg. 2011 Jun;114(6):1622-30. doi: 10.3171/2011.1.JNS101657. Epub 2011 Feb 11. |
| 27315026 | Background | Sagberg LM, Drewes C, Jakola AS, Solheim O. Accuracy of operating neurosurgeons' prediction of functional levels after intracranial tumor surgery. J Neurosurg. 2017 Apr;126(4):1173-1180. doi: 10.3171/2016.3.JNS152927. Epub 2016 Jun 17. |
| 25114561 | Background | Weldring T, Smith SM. Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs). Health Serv Insights. 2013 Aug 4;6:61-8. doi: 10.4137/HSI.S11093. eCollection 2013. |
| 28736345 | Background | Tomlinson SB, Piper K, Kimmell KT, Vates GE. Preoperative Frailty Score for 30-Day Morbidity and Mortality After Cranial Neurosurgery. World Neurosurg. 2017 Nov;107:959-965. doi: 10.1016/j.wneu.2017.07.081. Epub 2017 Jul 20. |
| 25046789 | Background | Reponen E, Tuominen H, Korja M. Evidence for the use of preoperative risk assessment scores in elective cranial neurosurgery: a systematic review of the literature. Anesth Analg. 2014 Aug;119(2):420-432. doi: 10.1213/ANE.0000000000000234. |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D001165 | Arteriovenous Malformations |
| D009072 | Moyamoya Disease |
| D006408 | Hematoma, Subdural |
| D046748 | Hematoma, Epidural, Spinal |
| D013345 | Subarachnoid Hemorrhage |
| D006849 | Hydrocephalus |
| D009128 | Muscle Spasticity |
| D014277 | Trigeminal Neuralgia |
| D005157 | Facial Pain |
| D009437 | Neuralgia |
| D014202 | Tremor |
| D020821 | Dystonic Disorders |
| D009771 | Obsessive-Compulsive Disorder |
| D000069279 | Drug Resistant Epilepsy |
| D003863 | Depression |
| D006850 | Hydrocephalus, Normal Pressure |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D001157 | Arterial Occlusive Diseases |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D010146 | Pain |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D004827 | Epilepsy |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided