RollOut -Pre-Rolled TachoSil in Laparoscopic Utilisation. A Non-Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 8
- 主要终点
- Investigators Assessment of Tachosil
研究概览
简要总结
The purpose of this study is to describe ease of use and satisfaction with application of the pre-rolled TachoSil in laparoscopic procedures within approved therapeutic indication as per Summary of Product Characteristics (SmPC).
详细描述
The drug being observed in this study is called Tachosil. Tachosil is being used in open invasive surgery for use as a local haemostatic and tissue sealing. This study will look at the application and an overview on the ease of use of pre-rolled form of Tachosil in minimal invasive (laparoscopic) surgery, cost analysis along with the evaluation of participant's satisfaction with the product.
The study will enroll approximately 131 participants who will be inpatients. A participant can be included in the study when the physician has decided to use pre-rolled TachoSil according to the local SmPC and after obtaining informed consent from the participant. Participants will be analyzed in a routine setting after surgery.
Data from all participants will be collected from their files as well as study specific questions answered by the treating physician.
This multi-center trial will be conducted in 7 Austrian centers. The overall recruitment period is expected for 1 year and six months. Participants will be analyzed from the date of surgery till their discharge from hospital.
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
- •1- Inpatients planned for laparoscopic surgery, in the field of gynecology, urology and abdominal surgery where pre-rolled TachoSil was applied, 18 years or older.
排除标准
- •Has contraindications, such as hypersensitivity to the active pharmaceutical ingredients or to other components of pre-rolled TachoSil according to the current SmPC.
- •Is participating in another clinical trial.
结局指标
主要结局
Investigators Assessment of Tachosil
时间窗: Post-surgery until hospital discharge (up to 13 days)
Investigators were asked to evaluate the overall manageability and satisfaction with TachoSil in laparoscopic surgery. The overall manageability and satisfaction of TachoSil application was assessed using Likert scale. It is a 5-point scale, that ranges from 1-5, where 1=easy to use/satisfied to 5=difficult to use/not satisfied. Higher scores indicates difficulty and less satisfaction. The mean manageability satisfaction with the application of TachoSil were reported.
次要结局
- Duration of Hospital Stay(From date of surgery until hospital discharge (up to 13 days))
- Number of Participants With Pharmaco-economic Evaluation Based on Surgeon's Assessment(Intra-surgery and post-surgery until hospital discharge (up to 13 days))
- Number of Participants With Intra-operative and Post-operative Adverse Events (AEs)(Baseline up to 13 days)