Mesh Shrinkage Following Transfacial Suturing Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair: a Prospective, Randomised Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- mesh shrinkage
研究概览
简要总结
Hernia of the abdominal wall occur frequently after various surgical procedures of the abdomen and are increasingly performed by laparoscopic means. Different mesh fixation techniques are applied, but the influence of mesh fixation on shrinkage is not known in human patients. Therefore, mesh shrinkage was assessed using two different techniques for fixation.
详细描述
Ventral hernia repair is increasingly performed by laparoscopic means. While mesh ingrowth and shrink-age has been analysed in the experimental setting, there is scarce data available in humans. In addition, different mesh fixation techniques are applied, but the influence of mesh fixation on shrinkage is not known in human patients.
Mesh shrinkage is assessed using two different techniques for fixation.
Blinded randomized trial using a Parietene composite mesh for laparoscopic ventral hernia repair. Patients with ventral hernias of no larger than 8 cm were assigned to either mesh fixation using transfacial nonabsorbable sutures or titan tacks. Primary endpoint was mesh migration, secondary endpoints were mesh shrinkage, surgical morbidity and pain.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with incisional hernia smaller than 8cm in diameter
- •obtained informed consent
排除标准
- •Pregnancy
- •Residual intraperitoneal mesh
- •contaminated abdominal cavity
- •longterm use of corticosteroids and other immunosuppressive agents
- •bodymass index > 45
- •general contradictions for laparoscopy
结局指标
主要结局
mesh shrinkage
时间窗: perioperative, 6 weeks, 6 months postoperative
次要结局
- recurrence(perioperative, 6 weeks postoperative,6 months, 12 months postoperative)
- mesh dislocation(perioperative, 6 weeks postoperative,6 months postoperative)
- pain(perioperative, 6 weeks postoperative,6 months, 12 moths postoperative)