NCT02881359Unknown不适用
SEAL Registry - Observational, Retrospective and Prospective, One Arm, Registry Study for the Effectiveness of LifeSeal® Kit on Anastomotic Leaks in Patients Undergoing Low and Ultralow Anterior Resection
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Incidence of post-operative clinical anastomotic leaks at discharge
研究概览
简要总结
This study will assess the effectiveness of commercially available LifeSeal® Kit as measured by the incidence of post-operative clinical anastomotic leak rates in subjects undergoing low and ultralow anterior resection with an anastomosis. All patients treated with LifeSeal® will be offered to participate
详细描述
The LifeSeal® Kit is a novel surgical sealant intended to be used as an adjunct to suture or staple line during standard surgical repair of the GI tract (anastomosis or linear) to provide re-inforcement and help reduce leaks. The LifeSeal™ Kit has recently been CE certified on March 2016 for marketing in the European Union.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •≥ 18 years of age at screening visit
- •Written informed consent obtained
- •Subject is scheduled to have or already underwent elective open, laparoscopic or robot assisted surgery involving the creation of a coloanal or colorectal anastomosis* created within 15 cm from the anal verge.
- •Subject was already treated or is scheduled to be treated with LifeSeal® Kit, applied according to the IFU
排除标准
- •Subject with American Society of Anesthesiology (ASA) status > 3.
结局指标
主要结局
Incidence of post-operative clinical anastomotic leaks at discharge
时间窗: discharge from hospital 3-14 days post surgery
次要结局
- Incidence of post-operative clinical anastomotic leaks up to 4 weeks post-surgery(up to 4 weeks post surgery)
研究者
研究点 (8)
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