Prospective MRI Follow-up After Retromuscular Incisional Hernia Repair Using the Dynamesh CICAT Visible® Mesh
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- visualization of the mesh surface
研究概览
简要总结
The aim of this study is the visualization of the mesh surface and the confirmation with MRI scan at 1 month and 13 months after standardized retromuscular incisional hernia repair with the visible CICAT mesh (Dynamesh®).
详细描述
INTRODUCTION:
Repair of ventral hernias always involves a scientific discussion about placing the "optimal mesh", the "optimal" mesh position or the "optimal" fixation method of the mesh. Today, there are a lot of meshes available of different materials, different textures, in different sizes and with different properties. The choice of the "right" mesh strongly depends on the sort of hernia and on the choice of the surgeon.
Furthermore, it is known that the majority of implanted meshes shrink to an extent, which may be of disadvantage for the patient. This has already been demonstrated in several animal studies, but clinical information on the mesh shrinkage is rare and mostly a result from revised surgery.
Most meshes for repair of abdominal hernia defects, based on polymeric textile, are invisible to conventional imaging techniques, inclusive "magnetic resonance imaging" (MRI). The textile company FEG Textiltechnik GmbH, Germany, has developed a unique method which allows imaging of the mesh in vivo in the MRI. For this purpose, these unique meshes contain an amount of iron particles. The particles are incorporated into the filaments, which are subsequent warp knitted to the mesh structure.
In a similar setting, the IMAP study, the visibility of the IPOM® mesh up to 13 months after laparoscopic ventral hernia repair will be investigated. Preliminary results from this study have shown a clear visibility and a promising outcome using this mesh.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for an retromusculare repair of an incisional hernia
排除标准
- •<18 years
- •Emergency surgery (incarcerated hernia)
- •Clean-contaminated or contaminated procedures
- •ASA score> 4
- •Pregnancy
- •No patient Informed Consent
- •Life expectancy of less than 2 years
结局指标
主要结局
visualization of the mesh surface
时间窗: 1 month
Clear visualization of the CICAT® prosthesis at 1 month postoperatively with MRI
次要结局
- visualization of the mesh surface(up to 13 months)
- calculation of the mesh surface(up to 13 months)
研究者
Filip Muysoms
Head of the Department of Surgery
Algemeen Ziekenhuis Maria Middelares
