Neurosurgical Outcome Network
Recruiting · NCT06724029 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
27 locations listed.
- 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
- 1. ASST Papa Giovanni XXIII - Bergamo, BG, Italy
- Spedali Civili Brescia - Brescia, BS, Italy
- Fondazione Poliambulanza Istituto Ospedaliero - Brescia, BS, Italy
- ASST Lariana, Ospedale S. Anna - Como, CO, Italy
- ASST Cremona - Cremona, CR, Italy
- Ospedale Moriggia Pelascini - Gravedona, Como, 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