Non-randomised, Open, Multi-center Trial Evaluating Feasibility and Safety of TachoSil® Application on a Colorectal Anastomosis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Nycomed
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor
研究概览
简要总结
The primary objective is to evaluate if the application of TachoSil® on a colorectal anastomosis is feasible and safe.
The secondary objective is to establish and describe optimal application methods to be used for educational purposes in future trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
研究组 & 干预措施
TachoSil®
干预措施: TachoSil® (Drug)
结局指标
主要结局
The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor
时间窗: Day of surgery
Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording. To ensure an independent assessment, the recording was assessed by an external, blinded assessor. In case of discrepancies between the assessment of the investigator and the assessor, the application was regarded as not feasible.
次要结局
- The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator.(Day of surgery)