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

Active, not recruiting

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

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Italia
      • Alessandria, Italia, Italy, 15121
        • Neurosurgery Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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, histological, and postoperative outcome data were retrospectively collected from medical records.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

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.
From preoperative assessment to last available follow-up (up to 24 months post-surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Complications
Time Frame: From surgery to 30 days postoperatively
Evaluation of postoperative complications, including hemorrhage, infections, dural fistula, and new neurological deficits, occurring after surgical treatment of intradural spinal tumors.
From surgery to 30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 31, 2024

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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