- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05678608
Surgical Outcome of Dorsolumbar Intradural Extramedullary Spinal Cord Tumors
Primary spinal cord tumors constitute 2-4% of all central nervous system neoplasms; they are classfied as extradural, intradural extramedullary (IDEM: 65%), and intramedullary The most commonly seen IDEM tumors are schwannomas, neurofibromas, and meningiomas. [1] The less frequently encountered IDEM tumors include ependymomas, lipomas, hemangiomas, metastatic deposits, paragangliomas, nerve sheath myxomas, and vascular tumors.[2] Spinal cord tumors can cause different signs and symptoms, especially as tumors grow. The tumors may affect spinal cord or the nerve roots, blood vessels or bones of spine. Signs and symptoms may include: Pain at the site of the tumor due to tumor growth Back pain, often radiating to other parts of body Feeling less sensitive to pain, heat and cold Loss of bowel or bladder function Difficulty walking, muscle weakness .
MRI is the investigation of choice,however other investigation such CT or X ray are important to ensure stability of the vertebral column and the optimal management is gross total excision for symptomatic lesions.[3,4] Over the years, there has been no significant change in the clinical symptoms and pathology of IDEM tumors. However, there have been dramatic improvements in the diagnosis and treatment with the advances of radiological and surgical techniques. Despite advances in operative techniques and neuroimaging, the morbidity associated with the resection of IDEM tumors continues to be significant [5,6].
Here, we examined the surgical outcomes of 20 patients with IDEM spinal cord tumors operated in Neurosurgery department at Sohag university Hospital
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: mohamed M kassem, demonstrator
- Phone Number: 010980-03153
- Email: mohamed011152@med.sohag.edu.eg
Study Contact Backup
- Name: mohammed M abd el-Aal, professor
- Phone Number: 01123728094
Study Locations
-
-
-
Sohag, Egypt
- Recruiting
- Sohag University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients with intradural extramedullary lesion in dorsolumber region
Exclusion Criteria:
- previous history of spinal surgery
- unfit medical patients
- multiple level affection
- associated cervical lesion
- unstable segment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: spinal cord tumors group
|
posterior midline approach and total excision for spinal cord tumors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
american spinal injury association scale
Time Frame: 6 months
|
grading of impairment for motor and sensory functions grade A for complete sensory and motor loss grade E for normal motor and sensory
|
6 months
|
|
visual analogue pain scale
Time Frame: 6 months
|
pain scale from zero to ten depend on severity of pain,
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Song KW, Shin SI, Lee JY, Kim GL, Hyun YS, Park DY. Surgical results of intradural extramedullary tumors. Clin Orthop Surg. 2009 Jun;1(2):74-80. doi: 10.4055/cios.2009.1.2.74. Epub 2009 May 27.
- Abul-Kasim K, Thurnher MM, McKeever P, Sundgren PC. Intradural spinal tumors: current classification and MRI features. Neuroradiology. 2008 Apr;50(4):301-14. doi: 10.1007/s00234-007-0345-7. Epub 2007 Dec 15.
- Narayan S, Rege SV, Gupta R. Clinicopathological Study of Intradural Extramedullary Spinal Tumors and Its Correlation With Functional Outcome. Cureus. 2021 Jun 18;13(6):e15733. doi: 10.7759/cureus.15733. eCollection 2021 Jun.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- soh-med-22-12-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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