Posterior Corpectomy in Thoracolumbar Spinal Metastatsis

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06117475
Collaborator
(none)
30
13

Study Details

Study Description

Brief Summary

To analyze the short-term outcomes of posterior corpectomy of patients with thoracolumbar spinal metastasis in spine unit in Assiut University hospital regarding the pain control , neurological status , complication and ambulatory status as well as mortality rate.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Posterior corpectomy

Detailed Description

The metastasis is the spread of cancer from one part of the body to another. Two-thirds of patients with cancer will develop bone metastases. Breast, prostate and lung cancer are responsible for more than 80% of cases of metastatic bone disease. A spinal metastasis may cause pain, instability and neurological injuries.

  • The spine is the most common site of bone metastasis . It is estimated that over the 10% of patients with cancer will develop a symptomatic spinal metastasis . Algra et al. suggest that the initial anatomic location of metastases within vertebrae is in the posterior portion of the body.

  • Spinal metastases are the most common tumors of the spine, comprising approximately 90% of masses encountered with spinal imaging. Within the spinal column, metastasis is more commonly found in the thoracic region, followed by the lumbar region, while the cervical region is the least likely place professionals find metastasis .

  • Spinal metastases most commonly affect the vertebral bodies of the spinal column, and spinal cord compression is an indication for surgery. Commonly, an open posterior approach is employed to perform a transpedicular, costotransversectomy or lateral extracavitary corpectomy. Because of the short life expectancies in patients with metastatic spinal disease, decreasing the morbidity of surgical treatment and recovery time is critical.

  • At present, both surgical and nonsurgical treatments are used for the treatment of spinal tumors, however, treatment outcome is dependent on various factors, such as patient age, overall health of the patient .

  • When treating patients with vertebral metastases, surgical strategy is mainly based on life expectancy, primary site of tumor, and staging. This helps determine which patients will benefit from surgery and the type of procedure. Tokuhashi developed a score to determine life expectancy in order to facilitate the treatment modality decision .

  • Vertebral corpectomy refers to the removal of one or more vertebral bodies from the spine, as well as the intervertebral discs above and below the surgical level.

Corpectomies may be accomplished through a multitude of approaches. Posterior approaches have been associated with less intraop- erative blood loss, complications, shorter operative time, and better pul- monary function post-operation compared to anterior approaches .

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Short-term Outcomes of Posterior Corpectomy in Thoracolumbar Spinal Metastatsis in Assiut University Hospitals
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Quality of patient life postoperatively [5Q-ED score through complete the study about 1to 1.5 years]

    Measure quality of life postoperatively by mobility, self care , usual activity ( e.g work, study, housework ) , pain /discomfort and anxiety and depression by 5Q-ED score ( EUROQOL EUROQOL 5 Dimension 5 levels ). EQ-5D-5L profile data can be summarised in the same way. 11111 again means no problem on any of the five dimensions of health and the worst health state is 55555. 1 means no problem , 5 means unable to do

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:

Patients > 18 years old Patient diagnosed as cancer Intractable pain Progressive neurologic comprise Radioresistant tumors

  • Failure of radiotherapy

  • Failure of chemotherapy

  • Fit for surgery

Exclusion Criteria:

Patient younger 18 years old spinal 1ry tumor

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Principal Investigator: Mohammed Gamal, Professor, Assiut University
  • Principal Investigator: Essam Elmorshidy, MD, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Rehab Mahmoud Ahmed Mohammed, Assiut lecturer, Assiut University
ClinicalTrials.gov Identifier:
NCT06117475
Other Study ID Numbers:
  • Spinal metastatses
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2023