NCT05678608

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

January 10, 2023

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

December 19, 2022

Last Update Submit

December 28, 2022

Conditions

Spinal Cord Tumor

Outcome Measures

Primary Outcomes (2)

  • 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

    6 months

  • visual analogue pain scale

    pain scale from zero to ten depend on severity of pain,

    6 months

Study Arms (1)

spinal cord tumors group

EXPERIMENTAL
Procedure: surgical excision

Interventions

surgical excisionPROCEDURE

posterior midline approach and total excision for spinal cord tumors

spinal cord tumors group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with intradural extramedullary lesion in dorsolumber region

You may not qualify if:

  • previous history of spinal surgery
  • unfit medical patients
  • multiple level affection
  • associated cervical lesion
  • unstable segment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

  • 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.

    PMID: 19885058BACKGROUND

  • 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.

    PMID: 18084751BACKGROUND

  • 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.

    PMID: 34285844BACKGROUND

MeSH Terms

Conditions

Spinal Cord Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsSpinal Cord DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

mohamed M kassem, demonstrator

CONTACT

010980-03153mohamed011152@med.sohag.edu.eg

mohammed M abd el-Aal, professor

CONTACT

01123728094

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
demonstrator at neurosurgery department

Study Record Dates

First Submitted

December 19, 2022

First Posted

January 10, 2023

Study Start

December 13, 2022

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

January 10, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share

Locations

EG(1)