Randomised Controlled Trial of Ventralex Versus Onlay Mesh Repair for Midline Incisional Hernias
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
- 否
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
Gabriel Sandblom
Associate Professor
Karolinska Institutet
