NCT01056913已完成4 期
Compression Anastomosis: Initial Clinical Experience With the ColonRingTM
St John of God Hospital, Vienna0 个研究点目标入组 62 人开始时间: 2008年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 主要终点
- Anastomotic Leakage
研究概览
简要总结
After resection of diseased segments of the large intestine, the continuity of the intestine has to be restored. This can be done by suturing or with so called stapling devices. In addition since 2 centuries compression rings are used to connect the intestine after resection. The NITICAR27 device is a novel compression anastomosis device. The investigators want to prove if this novel device can be compared to commonly used stapling devices concerning anastomotic leakage, bleeding and stenosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •benign and malign lesions of the colon and rectum
排除标准
- •advanced peritonitis (putrid, feculent)
结局指标
主要结局
Anastomotic Leakage
时间窗: 4-8 weeks
次要结局
- Clinical Relevant Stenosis(six months)
研究者
Bernhard Dauser, MD
MD
St John of God Hospital, Vienna
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