Neurosurgical Outcome Network

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-05

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Aneurysms Arteriovenous Malformations Cavernomas Skull Base Tumors Moyamoya Disease Dural Fistulas Subdural Hematoma Extradural Hematoma Subarachnoid Hemorrhage Hydrocephalus Parkinson&#39;s Disease Spasticity Trigeminal Neuralgia Craniofacial Pain Neuropathic Pain Tremor Dystonias Obsessive-compulsive Disorder Drug-resistant Epilepsy Depression Normal Pressure Hydrocephalus Tumors of Peripheral Nerves Chiari Malformation Type 1

Keywords

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Neurosurgery Outcome Artificial Intelligence predictors

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Udine, , Italy

Site Status RECRUITING

Countries

PMID: 25046789 (View on PubMed)

Other Identifiers

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NEON

Identifier Type: -

Identifier Source: org_study_id

Neurosurgical Outcome Network

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

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

Responsible Party

Locations

1. ASST Papa Giovanni XXIII

Spedali Civili Brescia

Fondazione Poliambulanza Istituto Ospedaliero

Ospedale Moriggia Pelascini

ASST Lariana, Ospedale S. Anna

ASST Cremona

Fondazione IRCCS San Gerardo dei Tintori

Fondazione IRCCS Policlinico San Matteo

ASST della Valtellina ed Alto Lario

Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"

Azienda Ospedaliero Universitaria Careggi

Ospedale F. Spaziani di Frosinone

Ospedale Alessandro Manzoni

ASST Ovest Milanese

Ospedali Riuniti di Livorno -Azienda USL Toscana nord ovest

Fondazione IRCCS Istituto Neurologico Carlo Besta

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

ASST Santi Paolo e Carlo

ASST Fatebenefratelli Sacco

Istituto Clinico Città Studi

Policlinico di Monza

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

Azienda Ospedaliero Universitaria di Parma

ASL Roma 1

Fondazione Policlinico Universitario Gemelli di Roma

IRCCS Istituto Clinico Humanitas

Azienda Sanitaria Universitaria Friuli Centrale di Udine

Countries

Central Contacts

Paolo Ferroli, MD

Morgan A Broggi, MD

Facility Contacts

Giuseppe Barbagallo, MD

Giuseppe Barbagallo, MD

Alessandro Della Puppa, MD

Alessandro Della Puppa, MD

Giancarlo D'Andrea, MD

Giancarlo D'Andrea, MD

Gianluca Grimod, MD

Gianluca Grimod, MD

Paolo Ferroli, MD

Morgan A Broggi, MD

Paolo Ferroli, MD

Morgan A Broggi, MD

Marcello Egidi, MD

Marcello Egidi, MD

Michele Incerti, MD

Michele Incerti, MD

Giovanni Tringali, MD

Giovanni Tringali, MD

Flavia Fraschetti, MD

Flavia Fraschetti, MD

Massimiliano Visocchi, MD

Massimiliano Visocchi, MD

Marco Vindigni, MD

Marco Vindigni, MD

References

Terrapon APR, Zattra CM, Voglis S, Velz J, Vasella F, Akeret K, Held U, Schiavolin S, Bozinov O, Ferroli P, Broggi M, Sarnthein J, Regli L, Neidert MC. Adverse Events in Neurosurgery: The Novel Therapy-Disability-Neurology Grade. Neurosurgery. 2021 Jul 15;89(2):236-245. doi: 10.1093/neuros/nyab121.

RANKIN J. Cerebral vascular accidents in patients over the age of 60. II. Prognosis. Scott Med J. 1957 May;2(5):200-15. doi: 10.1177/003693305700200504. No abstract available.

Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012 Jun;9(3):322-9. doi: 10.1177/1740774512438980. Epub 2012 Feb 27.

Jakola AS, Unsgard G, Solheim O. Quality of life in patients with intracranial gliomas: the impact of modern image-guided surgery. J Neurosurg. 2011 Jun;114(6):1622-30. doi: 10.3171/2011.1.JNS101657. Epub 2011 Feb 11.

Sagberg LM, Drewes C, Jakola AS, Solheim O. Accuracy of operating neurosurgeons' prediction of functional levels after intracranial tumor surgery. J Neurosurg. 2017 Apr;126(4):1173-1180. doi: 10.3171/2016.3.JNS152927. Epub 2016 Jun 17.

Weldring T, Smith SM. Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs). Health Serv Insights. 2013 Aug 4;6:61-8. doi: 10.4137/HSI.S11093. eCollection 2013.

Tomlinson SB, Piper K, Kimmell KT, Vates GE. Preoperative Frailty Score for 30-Day Morbidity and Mortality After Cranial Neurosurgery. World Neurosurg. 2017 Nov;107:959-965. doi: 10.1016/j.wneu.2017.07.081. Epub 2017 Jul 20.