Comparative Study on Different Bone Reconstruction After Chest Wall Tumor Resection

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Jiao Tong University Affiliated Sixth People's Hospital

About this trial

Chest wall tumors are one of the important diseases in thoracic surgery, and surgery is still the main treatment for this disease in clinical practice. Surgery for chest wall tumors requires extensive resection. However, the extensive chest wall defect formed after extensive resection can lead to the destruction of the integrity and stability of the chest wall, thus requiring chest wall reconstruction. The reconstruction of the chest wall after resection has always been a difficult point in chest wall tumor surgery, and the reconstruction of the chest wall bone is a key point in chest wall reconstruction. The goals of successful chest wall bone reconstruction include restoring chest wall rigidity, minimizing chest wall deformities, maintaining lung mechanics, and protecting thoracic organs. At present, traditional reconstruction methods are based on simulating and restoring the anatomical structure of the thoracic spine. For certain special areas of chest wall defects (such as posterior rib and paraspinal tumors), it is difficult to perform residual fixation; At the same time, traditional reconstruction methods suffer from insufficient stability after reconstruction, such as loosening, detachment, displacement, and even fracture. Therefore, it is necessary to design new chest wall reconstruction methods to meet clinical needs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-70 years old, male or female not limited

Anesthesia ASA score I-II

Malignant tumor of soft tissue in the chest

Malignant tumors of ribs, rib cartilage, and sternum

Disqualifiers

Patients with distant metastasis detected during preoperative examination

Inoperable tumor

During the examination, it was discovered that the patient had another type of malignant tumor present

ECOG 4

Trial design

Design model

Sequential

Treatments tested in this trial

  • methods on bone reconstrucion after chest wall tumor resection

    Procedure/Surgery

    Selecting appropriate implants for chest wall bone reconstruction

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: new methods on bone reconstruction after chest wall tumor resectionExperimental treatment 1 intervention
Group B: traditional methods on bone reconstruction after chest wall tumor resectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Stability of implants

The occurrence of detachment, displacement, and fracture of implants during follow-up in patients undergoing chest wall tumor surgery after receiving a new reconstruction method

Time frame
3 years

Secondary outcomes

1

Respiratory discomfort

Patient's respiratory discomfort in a calm state or walking state, measured as mild, moderate, or sereve after reconstruction surgery

Time frame
3 years
2

Postoperative complications

Pulmonary infection, atelectasis, pleural effusion, respiratory failure, postoperative drainage tube removal time, length of hospital stay

Time frame
3 years
3

Complications of implants

Fracture, displacement, infection, and compatibility of implants

Time frame
3 years
4

Postoperative physical function status

Karnofsky scoring scale

Time frame
3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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