RecruitingNCT06724029

Neurosurgical Outcome Network

Neurosurgical Outcome Network Per La Predizione Dell'outcome in Neurochirurgia


Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Enrollment

4,500 participants

Start Date

Dec 5, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria9

  • Neuro-oncological pathology: supratentorial and subtentorial tumors, intra and extra axial tumors excluding the skull base (anterior, middle and posterior fossa; sellar and parasellar region)
  • Basicranial pathology: tumors originating from the anterior cranial fossa, middle cranial fossa and posterior cranial fossa, sellar region with or without supratentorial/parasellar development.
  • Vascular pathology: aneurysms, AVMs, cavernomas, other pathologies (Moyamoya disease, 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, subarachnoid hemorrhage, intraparenchymal hematoma, fractures); hydrocephalus. The inclusion criterion for chronic subdural hematoma is recent bleeding for TBI with CT finding of chronic subdural hematoma candidate for evacuation surgery.
  • Spinal pathology: degenerative cervical (anterior/posterior), myelopathic, and trauma pathology; instrumented, uninstrumented thoracolumbar pathology (disc pathology, canal pathology), and trauma pathology; oncologic spinal pathology.
  • Functional pathology: Parkinson's disease, spasticity, trigeminal neuralgia, craniofacial pain/algia, neuropathic pain, tremor, dystonias, obsessive compulsive disorder, 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 both those framed in malformative syndromes and those not framed in malformative syndromes (monosutural craniostenoses: trigonocephaly, plagiocephaly, scaphocephaly; multisutural craniostenoses). Malformative hydrocephalus.
  • For cognitive and psychological assessment: age 18 years or older; adequate understanding of Italian language; diagnosis of glioma, meningioma, vascular pathology, spinal pathology

Exclusion Criteria1

  • For cognitive and psychological assessment: patients with psychiatric diseases in history and/or taking psychotropic drugs; presence of overt cognitive decline (not due to the injury) in history; patients younger than 18 years old.

Locations(27)

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

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

Ospedale F. Spaziani di Frosinone

Frosinone, Italy

Ospedale Alessandro Manzoni

Lecco, Italy

ASST Ovest Milanese

Legnano, Italy

Ospedali Riuniti di Livorno -Azienda USL Toscana nord ovest

Livorno, Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

ASST Santi Paolo e Carlo

Milan, Italy

ASST Fatebenefratelli Sacco

Milan, Italy

Istituto Clinico Città Studi

Milan, Italy

Policlinico di Monza

Monza, Italy

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

Palermo, Italy

Azienda Ospedaliero Universitaria di Parma

Parma, Italy

ASL Roma 1

Roma, Italy

Fondazione Policlinico Universitario Gemelli di Roma

Roma, Italy

IRCCS Istituto Clinico Humanitas

Rozzano, Italy

Azienda Sanitaria Universitaria Friuli Centrale di Udine

Udine, Italy

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NCT06724029


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