Evaluating outcomes in neurosurgery using standardized measures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess neurosurgical outcomes and their predictors across various centers. By standardizing the evaluation of outcomes and predictors, the study seeks to improve research quality and facilitate a common language in clinical practice. It will collect pre- and postoperative clinical, cognitive, and psychological data from patients undergoing neurosurgical interventions. The study also aims to identify specific predictors that influence therapeutic decisions in conditions such as aneurysms and tumors.

Why it matters

Who can join: the full rules

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's running

• Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
  Catania, Italy Recruiting
• Azienda Ospedaliero Universitaria Careggi
  Florence, Italy Recruiting
• Ospedale F. Spaziani di Frosinone
  Frosinone, Italy Recruiting
• Ospedali Riuniti di Livorno -Azienda USL Toscana nord ovest
  Livorno, Italy Recruiting
• Fondazione IRCCS Istituto Neurologico Carlo Besta
  Milan, Italy Recruiting
• ASST Santi Paolo e Carlo
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Paolo Ferroli, MD
• Email: paolo.ferroli@istituto-besta.it
• Phone: +39 02 2394 2411

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.