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Evaluating outcomes in neurosurgery using standardized measures

Neurosurgical Outcome Network Per la Predizione Dell'Outcome in Neurochirurgia

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · NCT06724029

This study is trying to see how different factors affect the results of brain surgeries by collecting information from patients before and after their operations.

Quick facts

Study typeObservational
Enrollment4500 (estimated)
Ages18 Years and up
SexAll
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta (other)
Locations27 sites (Bergamo, BG and 26 other locations)
Trial IDNCT06724029 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with neuro-oncological, vascular, or traumatic pathologies requiring neurosurgical intervention.

Not a fit: Patients with conditions not requiring neurosurgical intervention or those with non-neurosurgical pathologies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide more precise guidance for patients undergoing neurosurgery, improving their outcomes and quality of life.

How similar studies have performed: Other studies have shown success in standardizing outcome measures in neurosurgery, suggesting that this approach could be beneficial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Bergamo, BG and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Aneurysms, Arteriovenous Malformations, Cavernomas, Skull Base Tumors, Moyamoya Disease, Dural Fistulas, Subdural Hematoma, Extradural Hematoma

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.