RORA (Reinforcement of Rectal Anastomosis(<10cm) With HemoPatch - Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Evidence of clinical anastomotic leak( elevated C reactive protein and white blood corpuscles, fever, nausea). Suspicion of a leak will be investigated with a Ct scan.
研究概览
简要总结
The anastomotic leaks are multivariable in its origin. The incidence varies among different centers between 4% and as high as 25%. The impact of leakage in a rectal anastomosis can be devastating for the patient and very costly for the health care system.
Prolonged hospital stay (LOS), invasive treatment and intensive care are the consequences.
The future of colorectal surgery will increasingly include older patients with increased preoperative morbidity and probably even higher risk for anastomotic leaks. which makes it suitable for reinforcing a rectal anastomosis. The goal is to shift the clinical leaks spectrum into a subclinical and therefore self-healing one.
详细描述
The rationale is to explore if the procedure of reinforcement with HemoPatch and bringing more mechanical strength over an extended area around the anastomosis thus lowers the incidence of clinical anastomotic leaks.
The characteristics of HemoPatch, with its structural properties such as flexibility and tissue adhesion are suitable for this purpose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rectal surgery with anastomosis below 10 cm from anal verge
排除标准
- 未提供
结局指标
主要结局
Evidence of clinical anastomotic leak( elevated C reactive protein and white blood corpuscles, fever, nausea). Suspicion of a leak will be investigated with a Ct scan.
时间窗: 10 days
次要结局
未报告次要终点