The 2005 Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management: Taking Stock After 5-year Follow up
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Early postoperative complications
研究概览
简要总结
From its introduction in 2000 until its US recall in December 2005, the Composix Kugel Mesh was implanted in an estimated 350,000 patients worldwide.
The purpose of the study is to evaluate retrospectively the complications related to this mesh that occurred in our patients between 2003 and 2005, since new complications continue to be diagnosed, although the investigators discontinued the use of the mesh.
详细描述
From 2003 to 2005(2006) we implanted Komposix Kugel Meshes in 21 Patients with incisional ventral hernias. With the recall of January 2006 (in Germany), we stopped the implantation of this mesh and continued to monitor the patients with follow up and phone interviews. Late complications still continue to occur, mainly as a consequence of the product defect identified 7 years ago.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Age > 18
- •Incisional hernia
排除标准
- •Younger than 18 years
- •Peritonitis
- •Intestinal fistula
结局指标
主要结局
Early postoperative complications
时间窗: 6 months postoperative
Assessment of postoperative complications (wound complication, mesh infection, seroma)
次要结局
- Long-term postoperative complications(6 months to 5 years)
研究者
PD Dr. Dr. Ulrich A. Dietz
PD Dr. Dr.
University of Wuerzburg