Sublay Technique With Retromuscular Mesh Augmentation for Incisional Hernia Repair - A Prospective Randomized Multicentre Trial Comparing "Lightweight" Versus "Heavyweight" Meshes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- foreign body sensation
研究概览
简要总结
In this randomized, controlled, prospective multicentre clinical trial with a parallel group design a large-pore, lightweight polypropylene mesh (Ultrapro®) is compared to a small-pore, heavyweight polypropylene mesh (Premilene®), within a standardized, retromuscular mesh augmentation to identify the superiority of the lightweight mesh. Included patients are examined at five scheduled follow-up visits (5 and 21 days, 4, 12 and 24 months after surgery). The primary outcome criterion is foreign body sensation 12 month after surgery. Further secondary endpoint criteria are the occurrence of haematoma or haematoma requiring surgery at the 5-day visit, seroma, wound infection, and chronic pain within 24 months postoperatively. Quality of life was investigated by the SF-36®.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •fascial defect after vertical midline laparotomy with a minimum of 4 cm in diameter
排除标准
- •hernia of other location
- •recurrent hernia
- •incarcerated hernia
- •emergency surgery
- •patients with a malignancy or chemotherapy within the last 3 months
- •pregnancy
- •participation in other studies
- •patients with a wound infection
- •missing informed consent
结局指标
主要结局
foreign body sensation
时间窗: 12 month after surgery
Quality of life measurement based on the occurrence of a foreign body sensation for more than 3 months within 12 month after surgery.
次要结局
- wound infection(24 month)
- haematoma(5 days)
- postoperative seroma(24 month)
- chronic pain(24 month)
- hernia recurrence(24 month)
- hematoma requiring surgery(5 days)
研究者
Andreas Kroh, MD
Principal Investigator
RWTH Aachen University