跳至主要内容
临床试验/NCT01622725
NCT01622725已完成不适用

Recurrence Rate After Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.

University Hospital, Ghent11 个研究点 分布在 5 个国家目标入组 95 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
11
主要终点
Recurrence rate at 3 years post-surgery.

研究概览

简要总结

Since abdominal wall hernia repair is currently performed with the use of a mesh, side effects associated with the mesh are frequently reported during long term follow-up. These side effects are related to shrinkage of the mesh, adhesions to the bowl, pain, and inflammation of the skin and bowl. To reduce or prevent these effects, a fully resorbing mesh has been developed, which provides sufficient support and strength to allow efficient recovery of the abdominal wall, but also disappear from your body in three years time, so that you no longer have any synthetic material in your body. Previous resorbing meshes also disappeared but over a much shorter period of time, so that the hernia was insufficiently healed, with recurrence as a result.

The TIGR™ mesh (the resorbable mesh used in the study) is in principle a synthetic mesh, made of two commonly used polymers, however it will retain 50% of its initial strength after six months. This in theory is enough to provide support of the collagen healing process during the initial wound-healing phase, but also to support the transition of initial collagen to functional collagen.

The aim of this study is to compare TIGR™ with large pore mesh used in the repair of the anterior abdominal wall repair (incisional hernia, umbilical hernia, etc..Inguinal hernias are not part of the study).

Therefore the patients will be divided into two groups, one group will be treated with a resorbing mesh, the other group will be treated with a permanent mesh. Otherwise there will be no difference in the medication or the surgical techniques used.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary and secondary ventral hernia
  • less than 20 cm in length
  • less than 6 cm in width

排除标准

  • 未提供

结局指标

主要结局

Recurrence rate at 3 years post-surgery.

时间窗: 3 years post-surgery

Clinical evaluation and ultrasound evaluation after 3 years post-surgery.

次要结局

  • Pain and discomfort after 1 year post-surgery.(After 1 year post-surgery)
  • Wound Morbidity 4 weeks post-surgery.(4 weeks post-surgery)
  • Recurrence rate by clinical examination 1 year post-surgery.(After 1 year post-surgery.)
  • Pain and discomfort after 3 years post-surgery.(After 3 years post-surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (11)

Loading locations...

相似试验

Primary and Secondary Ventral Hernia Repair Using... | 临床试验