Neurosurgical Outcome Network

Last updated: December 17, 2024
Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Sjögren-larsson Syndrome

Birth Defects

Treatment

N/A

Clinical Study ID

NCT06724029
NEON
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Neuro-oncological pathology: supratentorial and subtentorial tumors, intra and extraaxial tumors excluding the skull base (anterior, middle and posterior fossa; sellarand parasellar region)

  • Basicranial pathology: tumors originating from the anterior cranial fossa, middlecranial fossa and posterior cranial fossa, sellar region with or withoutsupratentorial/parasellar development.

  • Vascular pathology: aneurysms, AVMs, cavernomas, other pathologies (Moyamoyadisease, dural fistulas, nontraumatic hematomas)

  • Traumatic pathology: diffuse damage (nonvisible diffuse damage, diffuse damage,diffuse damage with edema, diffuse damage with shift) and focal damage (acute/subacute/chronic subdural hematoma, extradural hematoma, subarachnoidhemorrhage, intraparenchymal hematoma, fractures); hydrocephalus. The inclusioncriterion for chronic subdural hematoma is recent bleeding for TBI with CT findingof chronic subdural hematoma candidate for evacuation surgery.

  • Spinal pathology: degenerative cervical (anterior/posterior), myelopathic, andtrauma pathology; instrumented, uninstrumented thoracolumbar pathology (discpathology, canal pathology), and trauma pathology; oncologic spinal pathology.

  • Functional pathology: Parkinson's disease, spasticity, trigeminal neuralgia,craniofacial pain/algia, neuropathic pain, tremor, dystonias, obsessive compulsivedisorder, drug-resistant epilepsies, depression. Normotensive hydrocephalus.

  • Peripheral nervous system pathology: peripheral nerve compression syndromes,peripheral nerve and plexus tumors, brachial plexus and peripheral nerve trauma (contusion and section)

  • Malformative pathology: Chiari malformation type 1 and craniostenoses including boththose framed in malformative syndromes and those not framed in malformativesyndromes (monosutural craniostenoses: trigonocephaly, plagiocephaly, scaphocephaly;multisutural craniostenoses). Malformative hydrocephalus.

  • For cognitive and psychological assessment: age 18 years or older; adequateunderstanding of Italian language; diagnosis of glioma, meningioma, vascularpathology, spinal pathology

Exclusion

Exclusion Criteria:

  • For cognitive and psychological assessment: patients with psychiatric diseases inhistory and/or taking psychotropic drugs; presence of overt cognitive decline (notdue to the injury) in history; patients younger than 18 years old.

Study Design

Total Participants: 4500
Study Start date:
December 05, 2022
Estimated Completion Date:
June 30, 2027

Study Description

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).

Connect with a study center

  • 1. ASST Papa Giovanni XXIII

    Bergamo, BG 24127
    Italy

    Site Not Available

  • Fondazione Poliambulanza Istituto Ospedaliero

    Brescia, BS 25124
    Italy

    Site Not Available

  • Spedali Civili Brescia

    Brescia, BS 25123
    Italy

    Site Not Available

  • ASST Lariana, Ospedale S. Anna

    Como, CO 22100
    Italy

    Site Not Available

  • ASST Cremona

    Cremona, CR 26100
    Italy

    Site Not Available

  • Ospedale Moriggia Pelascini

    Gravedona, Como 22015
    Italy

    Site Not Available

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, MB 20900
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, PV 27100
    Italy

    Site Not Available

  • ASST della Valtellina ed Alto Lario

    Sondrio, SO 23100
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"

    Catania,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Careggi

    Firenze,
    Italy

    Active - Recruiting

  • Ospedale F. Spaziani di Frosinone

    Frosinone, 03100
    Italy

    Active - Recruiting

  • Ospedale Alessandro Manzoni

    Lecco, 23900
    Italy

    Site Not Available

  • ASST Ovest Milanese

    Legnano, 20025
    Italy

    Site Not Available

  • Ospedali Riuniti di Livorno -Azienda USL Toscana nord ovest

    Livorno,
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133
    Italy

    Active - Recruiting

  • ASST Fatebenefratelli Sacco

    Milano,
    Italy

    Site Not Available

  • ASST Santi Paolo e Carlo

    Milano, 20153
    Italy

    Active - Recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Site Not Available

  • Istituto Clinico Città Studi

    Milano,
    Italy

    Site Not Available

  • Policlinico di Monza

    Monza, 20900
    Italy

    Active - Recruiting

  • A.R.N.A.S. Ospedali Civico di Palermo

    Palermo, 90127
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria di Parma

    Parma,
    Italy

    Site Not Available

  • ASL Roma 1

    Roma, 00135
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Gemelli di Roma

    Roma, 00168
    Italy

    Active - Recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • Azienda Sanitaria Universitaria Friuli Centrale di Udine

    Udine, 33100
    Italy

    Active - Recruiting

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