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Surgical Outcome of Dorsolumbar Intradural Extramedullary Spinal Cord Tumors

Primary Purpose

Spinal Cord Tumor

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
surgical excision
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sohag University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

spinal cord tumors group

Arm Description

Outcomes

Primary Outcome Measures

american spinal injury association scale
grading of impairment for motor and sensory functions grade A for complete sensory and motor loss grade E for normal motor and sensory
visual analogue pain scale
pain scale from zero to ten depend on severity of pain,

Secondary Outcome Measures

Full Information

First Posted
December 19, 2022
Last Updated
December 28, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05678608
Brief Title
Surgical Outcome of Dorsolumbar Intradural Extramedullary Spinal Cord Tumors
Official Title
Surgical Outcome of Dorsolumbar Intradural Extramedullary Spinal Cord Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
spinal cord tumors group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
surgical excision
Intervention Description
posterior midline approach and total excision for spinal cord tumors
Primary Outcome Measure Information:
Title
american spinal injury association scale
Description
grading of impairment for motor and sensory functions grade A for complete sensory and motor loss grade E for normal motor and sensory
Time Frame
6 months
Title
visual analogue pain scale
Description
pain scale from zero to ten depend on severity of pain,
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed M kassem, demonstrator
Phone
010980-03153
Email
mohamed011152@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
mohammed M abd el-Aal, professor
Phone
01123728094
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy M Amin, professor

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
19885058
Citation
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.
Results Reference
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PubMed Identifier
18084751
Citation
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.
Results Reference
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PubMed Identifier
34285844
Citation
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.
Results Reference
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Surgical Outcome of Dorsolumbar Intradural Extramedullary Spinal Cord Tumors

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