Clinical trial · Observational
Multicenter Trial on Surgical Outcome and Quality of Life in Juxta-medullary Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraspinal Tumor | Intraspinal Neoplasm | ALIAS | 0.90 |
| Juxtamedullary Tumor | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Quality of life based on the questionnaire
- timeFrame
- prior and 3 months after resection
- description
- The EuroQol 5-Dimension questionnaire (EQ-5D) is a standardized measure of health-related quality of life. It includes five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each rated on 3 or 5 levels, and a visual analogue scale (EQ VAS) from 0 (worst health imaginable) to 100 (best health imaginable). Higher EQ VAS scores indicate better health status. The descriptive system can also be converted to an index score ranging typically from \<0 (worse than death) to 1 (perfect health), where higher values reflect better health.
- measure
- Extent of tumor resection
- timeFrame
- 3 months after resection
- description
- 1\. Meningioma: Simpson grade 1 and 2 2. Schwannoma: complete resection, including nerve root 3. Cauda ependymoma: complete resection, including filum terminale according to postoperative MRI, 3 months after surgery 4. Other: surgeon's decision
- measure
- Neurological status
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult, age ≥18 years, patients treated on intraspinal, extra medullary tumor * Patients must have sufficient cognitive and language skills to give informed consent Exclusion Criteria: * Absence of informed consent * Lack of ability to consent * Primary bone tumors invading the intra-spinal space * Vertebral metastasis
References
Publications (0)
Data not yet available