Construction of a Clinical Prediction Model for Poor Prognosis Following Percutaneous Balloon Compression of the Trigeminal Ganglion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Pain recurrence (BNI≥Ⅲ)
研究概览
简要总结
This clinical study aims to investigate adverse outcomes following percutaneous balloon compression (PBC) of the trigeminal ganglion, establish a predictive model, and assess the probability of postoperative complications.The main question it aims to answer is:
- What factors are associated with adverse postoperative outcomes?
- What is the occurrence probability of different types of adverse outcomes? The study will record patients' demographic and clinical characteristics, laboratory test results, and conduct follow-ups at 3, 6, and 12 months postoperatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Pain recurrence (BNI≥Ⅲ)
时间窗: Follow-up timepoints: 3, 6, and 12 months postoperatively (final determination based on preliminary observation endpoints)
BNI Pain Intensity Scale Score: I:No pain,no medication II:Occasional pain,not requiring medication III:Some pain,adequately controlled with medication IV:Some pain,not adequately controlled with medication V:Severe pain/no pain relief
Severe sensory impairment (facial numbness with BNI sensory score ≥ Grade III)
时间窗: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
BNI Pain Intensity Scale Score: I:No pain,no medication II:Occasional pain,not requiring medication III:Some pain,adequately controlled with medication IV:Some pain,not adequately controlled with medication V:Severe pain/no pain relief
Masticatory dysfunction (bite force reduction ≥50% or subjective weakness)
时间窗: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
次要结局
- Mild sensory abnormalities (BNI sensory score Grade II)(3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).)
- Diplopia or hearing loss (rare complications to be recorded)(3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).)
- Postoperative infection (puncture site/intracranial)(3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).)
- Psychological status (change in HADS score)(3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).)