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

NCT ID: NCT06818552

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-21
• Study Completion Date: 2027-12-31

Brief Summary

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.

Detailed Description

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.

The 5-year survival of these tumors varies, in addition to the histotype and degree, also on the experience of the center where the treatment takes place; and is estimated at around 70% for soft tissue sarcomas, 60% in localized forms of osteosarcoma and 80% in localized forms of chondrosarcoma2-4.

The radicality of the surgical treatment of these neoplasms is dictated in large part by obtaining wide resection margins that often involve surgical excisions extending beyond the structures directly involved by the tumor5.

Very extensive musculoskeletal tumors frequently involve vascular structures. Data from the literature show that spinal surgery and orthopedic surgery are the specialist branches that most frequently require intra-operative 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 the vessels damaged during the cleavage and isolation of the mass, the ligation or complete reconstruction of the involved vascular segment and contributes to reducing intra-operative and post-operative complications7.

The primary objective of the study is to evaluate the outcomes of the interventions for the removal of musculoskeletal tumors, in relation to the type of vascular surgical assistance provided.

Conditions

Muscle Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mauro Gargiulo, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS AOU di Bologna Policlinico di Sant'Orsola

Bologna, Italia, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Mauro Gargiulo, MD

Role: CONTACT

mauro.gargiulo2@unibo.it

0512143288 ext. +39

Facility Contacts

Mauro Prof Gargiulo, MD

Role: primary

mauro.gargiulo2@unibo.it

0512143288

Other Identifiers

IOVA-mst

Identifier Type: -

Identifier Source: org_study_id