跳至主要内容
临床试验/NCT04356976
NCT04356976已完成不适用

Randomised Controlled Trial of Ventralex Hernia Patch Versus Stratafix Suture for Midline Primary Ventral Hernias

Karolinska Institutet1 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
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Hernia recurrence

研究概览

简要总结

Randomised controlled trial comparing Ventralex Hernia Patch with Stratafix suture for repair of primary ventral hernias in the midline.

详细描述

Primary hernias in the midline, including umbilical hernias and epigastric hernias, are among the most common conditions requiring surgery.

Mesh-reinforced as well as suture repair are used for the treatment of primary hernias, but for smaller umbilical hernias (diameter 1-3cm), there is little evidence for the superiority of mesh repair. Despite the widely use of composite ventral patch, there are few studies showing the advantage and disadvantage of ventral patch. In recent years, the barbed suture has been widely used in umbilical and incisional hernias, in laparoscopic as well as in open surgery. However, there are no studies comparing ventral patch with slowly absorbable barbed suture in open surgery.

The investigators intend to compare the use of sublay composite mesh (ventral-patch) with non-resorbable barbed prolene suture repair only and investigate recurrence rate and other short and long-term postoperative complications in these two methods.

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 the staff responsible for the postoperative care of the patient will be masked for the allocation.

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
否

入选标准

  • •Defect 1-4 cm
  • •Primary ventral hernia in the midline

排除标准

  • •Defect >4cm
  • •Recurrent hernia

研究组 & 干预措施

Ventralex

Experimental

Repair with Ventralex hernia patch in sublay position

干预措施: Ventralex (Device)

Stratafix

Active Comparator

Repair with Stratafix suture

干预措施: Stratafix (Other)

结局指标

主要结局

Hernia recurrence

时间窗: One year

Recurrence diagnosed at clinical and/or radiologic examination

次要结局

  • Persisting pain(One year)
  • Mean number of days postoperative sick leave(30 days)
  • Rate of intra-and postoperative complications(30 days)
  • Rate of seroma development(one year)

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 (1)

Loading locations...

相似试验