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NCT Number: NCT06724029

Neurosurgical Outcome Network

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.

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Key information

Conditions

Aneurysms Aneurysm Anxiety Disorders Arterial Occlusive Diseases Arteriovenous Malformations Behavior Behavioral Symptoms Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Carotid Artery Diseases Cavernomas Central Nervous System Diseases Cerebral Arterial Diseases Cerebrovascular Disorders Chiari Malformation Type 1 Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Craniocerebral Trauma Craniofacial Pain Depression Drug Resistant Epilepsy Drug-resistant Epilepsy Dural Fistulas Dyskinesias Dystonias Dystonic Disorders Epilepsy Extradural Hematoma Facial Nerve Diseases Facial Neuralgia Facial Pain Hematoma Hematoma, Epidural, Spinal Hematoma, Subdural Hemorrhage Hydrocephalus Hydrocephalus, Normal Pressure Intracranial Arterial Diseases Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Mental Disorders Mouth Diseases Movement Disorders Moyamoya Disease Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Neuropathic Pain Normal Pressure Hydrocephalus Obsessive-Compulsive Disorder Pain Parkinson&Amp;#39;s Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Skull Base Tumors Spasticity Stomatognathic Diseases Subarachnoid Hemorrhage Subdural Hematoma Trauma, Nervous System Tremor Trigeminal Nerve Diseases Trigeminal Neuralgia Tumors of Peripheral Nerves Vascular Diseases Vascular Malformations Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

1. ASST Papa Giovanni XXIII, Bergamo, BG, Italy

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Collect data

    Time frame: 5 years

    Collect and describe the pre- and postoperative clinical status in various neurosurgical pathologies.

  2. Collection data

    Time frame: 5 years

    Collect and describe the pre- and postoperative cognitive status in various neurosurgical pathologies.

  3. Collection data

    Time frame: 5 years

    Collect and describe the pre- and postoperative psychological status in various neurosurgical pathologies.

Secondary outcomes

  1. Identify Predictors

    Time frame: 1 year

    Identify outcome predictors.

Study contacts

Contact information is provided by the study sponsor or research team.

Morgan A Broggi, MD

CONTACT

[email protected]

+39 02 2394 2411 ext. 2411

Paolo Ferroli, MD

CONTACT

[email protected]

+39 02 2394 2411 ext. 2411

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Neurosurgical Outcome Network Per la Predizione Dell'Outcome in Neurochirurgia

Acronym: NEON

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2024
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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