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临床试验/NCT04358159
NCT04358159招募中不适用

Randomised Controlled Trial of Ventralex Versus Onlay Mesh Repair for Midline Incisional Hernias

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Recurrence rate

研究概览

简要总结

A radomised controlled trial comparing Ventralex patch and Progrip mesh in surgery for midline incisional hernias

详细描述

Incisional hernias in the midline is among the most common conditions requiring surgery. There are several factors which can increase the risk of incisional hernias, e.g. surgical technique, truncal obesity and other co-morbidities.

Repair with mesh-reinforcement is considered standard for the treatment of incisional hernias. Onlay and sublay mesh placements are the most commonly used methods. There are many different types of mesh available to use. Despite the widely use of composite ventral-patch Ventralex, there are few studies with small numbers of patients showing the advantage and disadvantage of ventral-patch. Some studies show that the onlay mesh-reinforcement remains a good alternative to the sublay mesh technique, while others showing fewer recurrences with the sublay mesh technique. The Ventralex mesh is usually placed on the peritoneum as a Intra peritoneum onlay mesh (IPOM). In this study intend to compare pre peritoneal Ventralex® mesh in sublay position with ProGrip self-fixating onlay mesh.

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)

盲法说明

The patient and staff responsible for the postoperative care of the patient are masked to the acollcation.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hernia defect 1-4 cm
  • Incisional hernia or recurrent hernia after previous primary hernia repair
  • Age 18-100 years

排除标准

  • Defect size>4 cm
  • Ongoing pregnancy
  • Primary hernia

结局指标

主要结局

Recurrence rate

时间窗: One year

Rate of hernia recurrences diagnosed at clinical and/or radiologic examination

次要结局

  • Rate of seroma(one year)
  • Sick leave(30 days)
  • Persisting postoperative pain(One year)
  • Rate ofntra- and postoperative complications(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriel Sandblom

Associate Professor

Karolinska Institutet

研究点 (2)

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