NCT00700141已完成不适用
Non-Interventional Study on the Use of TachoSil® During Thyroid Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nycomed
- 入组人数
- 482
- 试验地点
- 1
- 主要终点
- Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales
研究概览
简要总结
Considering the total number of thyroid procedures in Germany (100000 - 120000 cases per year), TachoSil® is a valuable tool to support surgical haemostasis, avoiding lymph leaks and support speech-nerve saving approaches. The aim of this study was to evaluate a patient and procedure profile where TachoSil® is most beneficial.
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
- •Patients undergoing total or subtotal thyroidectomy
排除标准
- •Contraindications, such as hypersensitivity to the active pharmaceutical ingredient or to another ingredient
结局指标
主要结局
Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales
时间窗: after surgery
Handling (1= very good to 10= very poor) Satisfaction (1= very satisfied to 10= totally unsatisfied) Utility (1= very useful to 10= completely useless)
次要结局
- Pharmacoeconomic Benefits as Assessed by the Surgeon(peri- and post-surgery until hospital discharge)
研究者
研究点 (1)
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