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临床试验/NCT02460029
NCT02460029Unknown不适用

Prospective MRI Follow-up After Retromuscular Incisional Hernia Repair Using the Dynamesh CICAT Visible® Mesh

Algemeen Ziekenhuis Maria Middelares1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年5月最近更新:
适应症

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

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

发起方
Algemeen Ziekenhuis Maria Middelares
申办方类型
Other
责任方
Principal Investigator
主要研究者

Filip Muysoms

Head of the Department of Surgery

Algemeen Ziekenhuis Maria Middelares

研究点 (1)

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