Multicenter Trial on Surgical Outcome and Quality of Life in Juxta-medullary Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Quality of life based on the questionnaire
研究概览
简要总结
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
详细描述
Introduction
- Background information Juxta-medullary tumors are mostly benign tumors in the spinal canal that may cause neurological deficits due to spinal cord or nerve root compression. The knowledge about the natural course of the disease, optimal treatment regarding timing of surgery and surgical approach are based on case series from different institutions around the world. Moreover, little is known about the long-term clinical and functional outcome after tumor resection, indicators of quality of treatment and quality of life after surgery.
Main treatment option of juxta-medullary tumors is a neurosurgical resection. The main goal of the surgery is to decompress the neuro structures in order to reveal neurological deficits. However, achieving gross total resection (GTR) is important in order to achieve long progression free survival (PFS).
Therefore, the surgeon should choose the appropriate surgical approach to achieve these goals. Several publications show that GTR, whenever possible, is essential, as subtotal resection is the main reason of tumor regrowth or recurrence. Moreover, revision surgery due to tumor recurrence is one of the main risk factors of unfavorable outcome, probably to intradural adhesions, related to the first procedure. Due to the mostly benign nature of juxtamedullary tumors, it would be very difficult to evaluate overall survival (OS) and progression free survival (PFS) within this progressive registry in the short run. For this reason, data should be kept for late cohort analysis after longer intervals. Probably up to 20 years, as previous publications reported recurrence of spinal meningioma after GTR 10 years or more after surgery.
On the other hand, too large exposure may lead to impaired recovery after surgery, eventual higher blood loss during surgery and thus longer stay in hospital (LOS) and impaired quality of life. Moreover, extensive bone resection may lead to spinal instability requiring instrumentation, during index surgery or during further follow up in case of postoperative deformity).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, age ≥18 years, patients treated on intraspinal, extra medullary tumor
- •Patients must have sufficient cognitive and language skills to give informed consent
排除标准
- •Absence of informed consent
- •Lack of ability to consent
- •Primary bone tumors invading the intra-spinal space
- •Vertebral metastasis
结局指标
主要结局
Quality of life based on the questionnaire
时间窗: prior and 3 months after resection
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.
Extent of tumor resection
时间窗: 3 months after resection
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
Neurological status
时间窗: prior to surgery and 3 months after surgery
The McCormick Functional Classification Scale for Spinal Cord Tumors assesses functional impairment in patients with intramedullary spinal tumors. It ranges from Grade I (minimal symptoms, fully active) to Grade IV (severe disability, dependent). The scale has four grades, with Grade I as the best and Grade IV as the worst outcome. Higher grades indicate greater neurological impairment and reduced functional independence.
次要结局
- Tumor Volume(prior to surgery and 3 months after surgery)
- Spinal Canal Ratio(prior surgery and 3 moths after surgery)
- Funtionality: Neck disability index (NDI) for tumors in the cervical spine(prior surgry and 3 months after surgery)
- Functionality: Oswestry disability index (ODI) for tumors in the thoracic and lumbar spine(prior and 3 months after surgery)
- Local and radicular pain(prior and 3 months after surgery)
- Neurological status(prior and 3 months after surgery)
- Motor deficits(prior surgery and 3 months after surgery)
- anxiety and depression(prior and 3 months after surgery)
- bladder functionality(prior and 3 months after surgery)
- Bowl functionality(prior surgery and 3 months after surgery)
- Sexual funtionality(prior and 3 months after surgery)
- Length of hospital stay(Perioperative/Periprocedural)
- 30-days readmission(3 months after surgery)
- 90-days readmission(3 months after surgery)
- Nosocomial infections(Perioperative/Periprocedural and 3 motnhs after surgery)
- estbimated blood loss(Perioperative/Periprocedural)
- Duration of surgery(Perioperative/Periprocedural")
- Progression of the disease or recurrence(3 months after surgery)
- adverse events(3 months after surgery)
- Mortality(3 months after surgery)
- advers events _2(Perioperative/Periprocedural and 3 months after surgery)
- CSF leakage(Perioperative/Periprocedural and 3 months after surgery)
- Postoperative kyphosis(3 months after surgery)
研究者
Michael Schwake
Director of the Neurosurgery Spine Section
University Hospital Muenster