跳至主要内容
临床试验/NCT02177214
NCT02177214已完成不适用

Prospective Study to Visualize Dynamesh ® IPOM Visible Mesh With MRI After Laparoscopic Intraperitoneal Ventral Hernia Repair.

Algemeen Ziekenhuis Maria Middelares1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Visualization

研究概览

简要总结

Purpose of the study is the visualization of the mesh and the determination of the mesh surface observed by MRI at 3 weeks and 13 months after ventral hernia repair with mesh visible IPOM (Dynamesh®). We want to prove that with this type of mesh it is possible to visualize the mesh position in vivo in a safe manner. This provides long-term benefit to early recognize possible recurrence caused by shifting or shrinking of the mesh and to provide early treatment.

详细描述

INTRODUCTION:

The repair of ventral hernias always goes along with a discussion about placing the optimal mesh, the optimum mesh position and the optimal fixation method of the mesh against the abdominal wall. There are a lot of meshes available of different materials, in different sizes and with different properties.

Penetrating fixation methods of the mesh have a strong positioning as result, but often at the cost of increased acute postoperative pain. Less or non-permanent (absorbable) fixation may decrease pain but should not risk a less stable mesh fixation ongoing with recurrence due to mesh shifting of mesh shrinkage.

It is indeed known that the majority of implanted meshes do 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.

All ordinary meshes for repair of abdominal hernia defects, based on polymeric textile, are invisible to conventional imaging techniques, inclusive "magnetic resonance imaging" (MRI). The IPOM mesh visible (Dynamesh®), developed by a unique method, contains an amount of iron particles, woven in the ordinary structure of the mesh, which allows an imaging in the MRI.

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 elective laparoscopic repair of ventral hernia

排除标准

  • •- <18 years
  • •Lateral hernias (L1-L4), subxyphoidale hernias (M1) or suprapubicale hernias (M5).
  • •Emergency surgery (incarcerated hernia)
  • •Clean-contaminated or contaminated procedures
  • •ASA score> 4
  • •Pregnancy
  • •No patient Informed Consent
  • •Life expectancy of less than 2years
  • •Contra-indications for MRI examination, as of:
  • •Implanted electronic devices such as a pacemaker, neuro-stimulator, cochlear implant.
  • •Not MRI-compatible valves.
  • •Metal foreign bodies (depending on the location relative to the region to investigate).
  • •Large tattoos. Note: By default, the patient has to complete a questionnaire before the start of the study. This will be followed with the radiology nurse post-MRI.
  • •Claustrophobia, shortness of breath, tremor.
  • •In doubt, an internationally accepted list of items will be checked on the website www.mrisafety.com.

结局指标

主要结局

Visualization

时间窗: 3 weeks

Clear visualization of the MRI IPOM prosthesis 3 weeks postoperatively

次要结局

  • mesh surface(13 month)

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 Abdominal Surgery

Algemeen Ziekenhuis Maria Middelares

研究点 (1)

Loading locations...

相似试验