Prospective Shunt Complication Study (Pro-ShuCS)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Alternate Diagnosis (multiple diagnoses possible)
研究概览
简要总结
Complications in patients with cerebrospinal fluid (CSF) shunts are common. Thus, these patients are frequently admitted for suspicion of a shunt dysfunction (SD). However, the symptoms of a SD are often unspecific and the required diagnostics are time consuming, expensive, invasive and may involve radiation exposure. In a prospective observational study it is planned to find out, how often a suspected shunt dysfunction is found, which kinds of shunt dysfunction are seen and if there is a correlation between the shunt dysfunctions and the age of the shunt. Furthermore, it is intended to find out, if there are symptom-patterns specific for certain shunt dysfunctions.
详细描述
All patients who are admitted for suspected shunt-dysfunction will be included. Patient data, detailed data about the shunt, patient's symptoms and all findings will be recorded in the CRF. After 4-8 weeks all patients will be followed-up to add missing data and correct initial findings with the benefit of a retrospective view. After 2 years, data will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age >= 18
- •State after implantation of a CSF shunt
排除标准
- •refusion participation in the study
结局指标
主要结局
Alternate Diagnosis (multiple diagnoses possible)
时间窗: 4-8 weeks after first presentation
If the suspected diagnosis of a shunt dysfunction is not approved, the alternate diagnosis leading to the patient's symptoms is recorded. Every possible medical disorder might lead to presentation of the patient. Thus, no catalogue of possible diagnoses is given.
Kind of Shunt Dysfunction (infection/disruption/kinking/obstruction/others)
时间窗: 4-8 weeks after first presentation
In case of a confirmed shunt dysfunction, the kind of dysfunction is recorded
Time Span after Shunt Implantation (months)
时间窗: 4-8 weeks after first presentation
Certain kinds of shunt dysfunctions seem to appear at a certain "age" of a shunt. The time after implantation/last revision of the shunt is recorded. The age of the shunt / time span after first implantation is measured in months.
Confirmation of Shunt Dysfunction (yes/no)
时间窗: 4-8 weeks after first presentation
The correctness of the suspected diagnosis of a shunt dysfunction
次要结局
未报告次要终点