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临床试验/NCT07488702
NCT07488702进行中(未招募)不适用

Intradurale Spinal Tumors: Management and Treatment - A Retrospective Observational Study

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年1月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50
试验地点
1
主要终点
Neurological Functional Outcome Assessed

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Incomplete medical records or missing clinical data required for the study.
  • Tumors with uncertain extradural extension identified during surgery.
  • Tumors arising from peripheral nerves.

结局指标

主要结局

Neurological Functional Outcome Assessed

时间窗: 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.

次要结局

  • Postoperative Complications(From surgery to 30 days postoperatively)

研究者

发起方
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
申办方类型
Other
责任方
Sponsor

研究点 (1)

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