Prospective Register Study to Assess Eligibility for and Efficacy of Surgical Treatment in Patients With nEuRovascular Conflict
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5,001
- 试验地点
- 2
- 主要终点
- Face specific pain relief after surgical treatment
研究概览
简要总结
The aim of the registry is a multicenter, prospective long-term data collection of patients suspected neurovascular conflict and referred for possible microvascular decompression (Jannetta procedure). The registry relies exclusively on routinely collected clinical data, which are gathered in a standardized and privacy-compliant manner as part of everyday clinical practice. By systematically compiling this information across multiple centers, valuable insights into the effectiveness, potential side effects, and long-term outcomes of this surgical treatment can be gained. The registry will serve as a foundation for future scientific analyses and is intended to help answer relevant research questions regarding the treatment of trigeminal neuralgia based on solid evidence.
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
- •suspected neurovascular conflict
- •signed consent for further use of routine clinical data as accepted by local regulations
排除标准
- •refusal of further use of routine clinical data
结局指标
主要结局
Face specific pain relief after surgical treatment
时间窗: From enrolment to last follow-up 5 yrs after surgery
Efficacy of microvascular decompression surgery, defined by the change in facial pain and pain interference as assessed by the patient using the Brief Pain Inventory-Facial (BPI-Facial), with numerical scores ranging from 0 to 10, where higher scores represent worse outcomes.
Pain relief after surgical treatment
时间窗: From enrolment to last follow-up 5 yrs after surgery
Efficacy of microvascular decompression surgery, defined by the change in pain as assessed by the patient using the Visual Analog Scale (VAS) from 0 to 100 mm, with higher scores representing worse outcomes.
次要结局
- Patient satisfaction(5yrs after index surgery)
- Effect of surgical treatment on quality of life(5 years after index surgery)
- Surgical complications(three months after index surgery)
- Need for additional treatment(5 years after index surgery)
研究者
Gerrit A Schubert
Head of Neurosurgery
Kantonsspital Aarau