Multicenter Trial on Surgical Outcome and Quality of Life in Juxta-medullary Tumors
Recruiting now
Conditions studied: Intraspinal Tumor, Juxtamedullary Tumor
In brief
Primary objectives: Primary objectives are to assess and define benchmarks of the surgical outcome in the form of extent of resection, functionality, and quality of life after resection of juxta medullary tumors Secondary objectives: Assessment of variables leading to better outcome through regression analysis: 1. Influence of surgical approach on functionality, pain, and quality of life 2. Comparison between patient with severe neurological (McCormick scale 3-5) to patients with mild deficits (McCormick scale 1-2) 3. Role of intraoperative monitoring (IOM) in extent of resection and neurological deficits Assessment of treatment variations: 1. Assessment of risk factors for incomplete resection 2. Non inferiority of unilateral approach to achieve gross total resection of spinal meningioma, schwannoma and cauda ependymoma 3. Role of bed rest after surgery to prevent cerebro-spinal fluid leakage 4. Influence of laminectomy on cerebro-spinal fluid leakage Quality indicators: assessments of length of hospital stay, 30- and 90-days re-admissions, 30- and 90-days re-surgery, nosocomial infections
Key facts
- Study ID
- NCT07056023
- Run by
- University Hospital Muenster
- People needed
- 100
- Starts
- 2025-05-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2025-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult, age ≥18 years, patients treated on intraspinal, extra medullary tumor
- Patients must have sufficient cognitive and language skills to give informed consent
You may not qualify if…
- Absence of informed consent
- Lack of ability to consent
- Primary bone tumors invading the intra-spinal space
- Vertebral metastasis
Where it is running
- University Hospital Muenster — Münster, Nordrhien Westfalen, Germany (enrolling)
Full record on ClinicalTrials.gov
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