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NCT04110457 Clinical Trial

Outcomes of Surgical Treatment of Patients With Spinal Metastasis in AUH

Spinal Metastases Clinical Trial

Official title:
Outcomes of Surgical Treatment of Patients With Spinal Metastasis in Assiut University Hospitals

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04110457
Other study ID # surgical treatment in spine
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date September 30, 2022

Study information
Verified date December 2022
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To analyze the outcomes of surgical treatment of patients with spinal metastases in spine unit in AUH regarding the pain control, neurological status and ambulatory status as well as survival rate .

Description:

this study monitor what is the results after operative treatment of patients which have secondary metastases in spinal column concerning quality of live for one year and pain and neurology

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date September 30, 2022
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients > 18 years old - Patient with tissue proven dx of cancer Exclusion Criteria: - Patient younger 18 years old - CNS or spinal 1ry tumor

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• spinal decompression
spinal surgery by decompression or fixation

Locations
Country Name City State
Egypt Assuit university Assiut
Egypt Assuit university Assuit

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Hirabayashi H, Ebara S, Kinoshita T, Yuzawa Y, Nakamura I, Takahashi J, Kamimura M, Ohtsuka K, Takaoka K. Clinical outcome and survival after palliative surgery for spinal metastases: palliative surgery in spinal metastases. Cancer. 2003 Jan 15;97(2):476-84. doi: 10.1002/cncr.11039. — View Citation

Maccauro G, Spinelli MS, Mauro S, Perisano C, Graci C, Rosa MA. Physiopathology of spine metastasis. Int J Surg Oncol. 2011;2011:107969. doi: 10.1155/2011/107969. Epub 2011 Aug 10. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate quality of life after surgery to evaluate the general condition using 5Q-ED score baseline
Secondary to analyze postoperative pain control , stability and ambulatory statues after surgical treatment of spinal metastases. evaluation of postoperative pain and neurology and comparing with preoperative data Baseline
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