Randomised Controlled Trial of Ventralex Hernia Patch Versus Stratafix Suture for Midline Primary Ventral Hernias
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
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
- Rate of intra-and postoperative complications(30 days)
- Rate of seroma development(one year)
- Persisting pain(One year)
- Mean number of days postoperative sick leave(30 days)
研究者
Gabriel Sandblom
Associate Professor
Karolinska Institutet
