- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07488702
Intradurale Spinal Tumors: Management and Treatment (GTTIR)
Intradurale Spinal Tumors: Management and Treatment - A Retrospective Observational Study
Intradurale spinal tumors are rare neoplastic lesions that involve the spinal cord and surrounding structures and may cause neurological symptoms such as pain, motor deficits, sensory disturbances, and sphincter dysfunction. Surgical resection is often the primary treatment when feasible and may improve neurological outcomes and relieve spinal cord compression.
This retrospective observational study aims to analyze the epidemiological and clinical characteristics of patients who underwent surgical treatment for intradural spinal tumors at the Neurosurgery Unit of Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria between 2022 and 2024.
Clinical, radiological, and pathological data will be collected from electronic medical records, operative reports, and diagnostic imaging. The study will evaluate preoperative and postoperative neurological status using the McCormick functional scale, as well as postoperative complications and tumor recurrence.
The results of this study may contribute to improving the understanding of the clinical management of intradural spinal tumors and identifying factors associated with surgical outcomes and patient prognosis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Intradural spinal tumors are uncommon neoplastic lesions involving the spinal cord and its surrounding structures. These tumors may be classified as intradural extramedullary or intramedullary depending on their origin and anatomical location. Although relatively rare, they represent an important clinical condition due to their potential to cause progressive neurological impairment, including pain, motor weakness, sensory deficits, and sphincter dysfunction.
Magnetic resonance imaging (MRI) represents the diagnostic gold standard for identifying and characterizing intradural spinal tumors. Surgical resection is generally considered the primary therapeutic option when feasible, with the aim of removing the lesion, decompressing the spinal cord, improving neurological symptoms, and obtaining a histological diagnosis. Advances in surgical techniques and intraoperative neurophysiological monitoring have contributed to improved surgical outcomes and postoperative recovery.
This study is a retrospective, single-center observational study conducted at the Neurosurgery Unit of the Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria, Italy. The study includes patients who underwent surgical treatment for intradural spinal tumors between 2022 and 2024.
Clinical data will be retrospectively collected from electronic medical records, surgical reports, imaging studies, and histopathological reports. The collected variables include demographic data, tumor characteristics (location and histology), clinical presentation, and postoperative outcomes.
The neurological functional status of patients will be evaluated using the McCormick functional scale, comparing preoperative and postoperative neurological conditions. Additional analyses will focus on postoperative complications and tumor recurrence.
The aim of this study is to provide a comprehensive description of the clinical and epidemiological characteristics of patients with intradural spinal tumors treated surgically at our institution and to contribute to a better understanding of the management and outcomes of this condition in clinical practice.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Italia
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Alessandria, Italia, Italy, 15121
- Neurosurgery Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients hospitalized at Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo di Alessandria (Neurosurgery Unit).
- Patients who underwent surgical resection of an intradural spinal tumor.
- Diagnosis consistent with intradural spinal tumors according to ICD-9 codes.
- Availability of clinical, radiological, and surgical data in medical records.
- Signed informed consent.
Exclusion Criteria:
- Incomplete medical records or missing clinical data required for the study.
- Tumors with uncertain extradural extension identified during surgery.
- Tumors arising from peripheral nerves.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients With Intradural Spinal Tumors
Patients who underwent surgical treatment for intradural spinal tumors at the Neurosurgery Unit of Azienda Ospedaliero-Universitaria SS.
Antonio e Biagio e Cesare Arrigo di Alessandria between 2022 and 2024.
Clinical, radiological, and histopathological data were collected retrospectively from medical records to evaluate patient characteristics, neurological outcomes, postoperative complications, and tumor recurrence.
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This study consists of retrospective data collection and analysis of patients who underwent neurosurgical resection of intradural spinal tumors.
No intervention is assigned as part of the study protocol.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neurological Functional Outcome Assessed
Time Frame: From preoperative assessment to last available follow-up (up to 24 months post-surgery)
|
Assessment of neurological functional status in patients undergoing surgical resection of intradural spinal tumors using the McCormick functional grading scale (Grade I: neurologically normal or mild deficit; Grade II: mild functional deficit, independent; Grade III: moderate deficit, limited independence; Grade IV: severe deficit, dependent; Grade V: paraplegia or quadriplegia).
Preoperative and postoperative scores will be compared to evaluate changes in neurological function.
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From preoperative assessment to last available follow-up (up to 24 months post-surgery)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Complications
Time Frame: From surgery to 30 days postoperatively
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Evaluation of postoperative complications, including hemorrhage, infections, dural fistula, and new neurological deficits, occurring after surgical treatment of intradural spinal tumors.
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From surgery to 30 days postoperatively
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Bone Diseases
- Musculoskeletal Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Neoplasms by Site
- Neoplasms
- Bone Neoplasms
- Spinal Diseases
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Spinal Cord Diseases
- Spinal Cord Injuries
- Spinal Cord Neoplasms
- Spinal Neoplasms
- Spinal Cord Compression
Other Study ID Numbers
- ASO.Nch.25.02
- Novara Ethical Committee (Other Identifier: 441.170)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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