Neurosurgical Outcome Network

Recruiting

• Conditions: Aneurysms; Arteriovenous Malformations; Cavernomas; Skull Base Tumors; Moyamoya Disease; Dural Fistulas; Subdural Hematoma; Extradural Hematoma; Subarachnoid Hemorrhage; Hydrocephalus

• Registration Number: NCT06724029
• Lead Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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).

Study Timeline

• Study Start: 2022-12-05
• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-06
• Study First Posted: 2024-12-09
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collect data	5 years	Collect and describe the pre- and postoperative clinical status in various neurosurgical pathologies.
Collection data	5 years	Collect and describe the pre- and postoperative psychological status in various neurosurgical pathologies.

Secondary Outcome Measures

Name	Time	Method
Identify Predictors	1 year	Identify outcome predictors.

Trial Locations

Locations (27)

1. ASST Papa Giovanni XXIII; 🇮🇹 Bergamo, BG, Italy

Spedali Civili Brescia; 🇮🇹 Brescia, BS, Italy

Fondazione Poliambulanza Istituto Ospedaliero; 🇮🇹 Brescia, BS, Italy

Ospedale Moriggia Pelascini; 🇮🇹 Gravedona, Como, Italy

ASST Lariana, Ospedale S. Anna; 🇮🇹 Como, CO, Italy

ASST Cremona; 🇮🇹 Cremona, CR, Italy

Fondazione IRCCS San Gerardo dei Tintori; 🇮🇹 Monza, MB, Italy

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, PV, Italy

ASST della Valtellina ed Alto Lario; 🇮🇹 Sondrio, SO, Italy

Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"; 🇮🇹 Catania, Italy

Azienda Ospedaliero Universitaria Careggi; 🇮🇹 Firenze, Italy

Ospedale F. Spaziani di Frosinone; 🇮🇹 Frosinone, Italy

Ospedale Alessandro Manzoni; 🇮🇹 Lecco, Italy

ASST Ovest Milanese; 🇮🇹 Legnano, Italy

Ospedali Riuniti di Livorno -Azienda USL Toscana nord ovest; 🇮🇹 Livorno, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milano, Italy

ASST Santi Paolo e Carlo; 🇮🇹 Milano, Italy

ASST Fatebenefratelli Sacco; 🇮🇹 Milano, Italy

Istituto Clinico Città Studi; 🇮🇹 Milano, Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta; 🇮🇹 Milan, Italy

Policlinico di Monza; 🇮🇹 Monza, Italy

A.R.N.A.S. Ospedali Civico di Palermo; 🇮🇹 Palermo, Italy

Azienda Ospedaliero Universitaria di Parma; 🇮🇹 Parma, Italy

ASL Roma 1; 🇮🇹 Roma, Italy

Fondazione Policlinico Universitario Gemelli di Roma; 🇮🇹 Roma, Italy

IRCCS Istituto Clinico Humanitas; 🇮🇹 Rozzano, Italy

Azienda Sanitaria Universitaria Friuli Centrale di Udine; 🇮🇹 Udine, Italy