Posterior Corpectomy in Thoracolumbar Spinal Metastatsis

November 2, 2023 updated by: Rehab Mahmoud Ahmed Mohammed, Assiut University

Short-term Outcomes of Posterior Corpectomy in Thoracolumbar Spinal Metastatsis in Assiut University Hospitals

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patient diagnosed as a spinal metastatsis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of patient life postoperatively
Time Frame: 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
5Q-ED score through complete the study about 1to 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

November 2, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Spinal metastatses

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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