Clinical trial NCT06724029: Neurosurgical Outcome Network
Official title: Neurosurgical Outcome Network Per La Predizione Dell'outcome in Neurochirurgia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aneurysms
Arteriovenous Malformations
Cavernomas
Skull Base Tumors
Moyamoya Disease
Dural Fistulas
Subdural Hematoma
Extradural Hematoma
Subarachnoid Hemorrhage
Hydrocephalus
Parkinson&amp;#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: Neurosurgery Outcome Artificial Intelligence predictors
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 4500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients older than 18 years old, with neurosurgical pathology

Brief summary: 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: 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).

Eligibility 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.

Primary outcomes:
measure: Collect data
timeFrame: 5 years
measure: Collection data
timeFrame: 5 years
measure: Collection data
timeFrame: 5 years
Secondary outcomes:
measure: Identify Predictors
timeFrame: 1 year
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: 1. ASST Papa Giovanni XXIII
state: BG
city: Brescia
country: Italy
facility: Spedali Civili Brescia
state: BS
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto Ospedaliero
state: BS
city: Gravedona
country: Italy
facility: Ospedale Moriggia Pelascini
state: Como
city: Como
country: Italy
facility: ASST Lariana, Ospedale S. Anna
state: CO
city: Cremona
country: Italy
facility: ASST Cremona
state: CR
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
state: MB
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
state: PV
city: Sondrio
country: Italy
facility: ASST della Valtellina ed Alto Lario
state: SO
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Frosinone
country: Italy
facility: Ospedale F. Spaziani di Frosinone
city: Lecco
country: Italy
facility: Ospedale Alessandro Manzoni
city: Legnano
country: Italy
facility: ASST Ovest Milanese
city: Livorno
country: Italy
facility: Ospedali Riuniti di Livorno -Azienda USL Toscana nord ovest
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: ASST Santi Paolo e Carlo
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco
city: Milano
country: Italy
facility: Istituto Clinico Città Studi
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta
city: Monza
country: Italy
facility: Policlinico di Monza
city: Palermo
country: Italy
facility: A.R.N.A.S. Ospedali Civico di Palermo
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Roma
country: Italy
facility: ASL Roma 1
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Gemelli di Roma
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale di Udine
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Reponen E, Tuominen H, Korja M. Evidence for the use of preoperative risk assessment scores in elective cranial neurosurgery: a systematic review of the literature. Anesth Analg. 2014 Aug;119(2):420-432. doi: 10.1213/ANE.0000000000000234.