跳至主要内容
临床试验/NCT06818552
NCT06818552招募中不适用

The Role of the Vascular Surgeon in Orthopedic Surgery of Musculoskeletal Tumors

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年6月21日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
Number of vascular issues during every procedure

研究概览

简要总结

Very large musculoskeletal tumors frequently involve vascular structures. Literature data show that spinal surgery and orthopedic surgery are the specialist branches that most frequently require intraoperative vascular surgical assistance, with 33.8% and 26.4% of requests, respectively6.

In these cases, the surgical assistance of the vascular surgeon allows the safe removal of the mass, the possible repair of vessels damaged during cleavage and isolation of the mass, the ligation or complete reconstruction of the involved vascular segment and contributes to reducing intraoperative and postoperative complications7.

详细描述

Musculoskeletal tumors and spinal tumors represent a large and heterogeneous group of neoplasms. They are divided into primary soft tissue tumors (deriving from the neoplastic transformation of muscle, connective, vascular, lymphatic, nervous and adipose cells), primary bone tumors (deriving from the precursor cells of bone and cartilage cells) and spinal tumors. These neoplasms, depending on their location, can be either benign (chondroblastoma, chondromyxofibroma, enchondroma, fibrous dysplasia, benign giant cell tumor, non-ossifying fibroma, osteoblastoma, osteochondroma, osteoid osteoma, hemangioma, aneurysmal cyst, eosinophilic granuloma) or malignant (soft tissue sarcomas, osteosarcomas, chondrosarcomas, chondromas, Ewing's sarcoma, fibrosarcoma and undifferentiated pleomorphic sarcomas of the bone, myeloma/plasmacytoma, chordoma, meningioma, neurofibroma and schwannoma).

The initial presentation is frequently related to the mass effect that these tumors cause when they reach large dimensions. Equally often, particularly in the case of bone tumors, pain and pathological fractures represent the initial symptoms.

Both soft tissue and bone sarcomas are rare diseases with an incidence of 5 cases per 100,000 and 1 case per 100,000 inhabitants, respectively (data from AIRC - Italian Association for Cancer Research)1.

Due to their cellular heterogeneity, these tumors can be located in different areas of the human body, with a preference for the trunk and limbs; and they are often infiltrating in nature.

Their treatment is based, depending on the histotype and the degree of disease at the time of diagnosis, on surgical removal of the tumor, chemotherapy (CT), radiotherapy (RT) or a combination of these different methods.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Patient diagnosed with musculoskeletal tumor involving vascular structures requiring surgical removal
  • Planned surgical treatment with intraoperative assistance of the vascular surgeon
  • Obtaining informed consent
  • Age 18 years

排除标准

  • 未提供

结局指标

主要结局

Number of vascular issues during every procedure

时间窗: From the first patient entrolled up to the 70th patient, up to 3 years

Number of major and minor vascular complications are collected during every procedure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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