Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm Repair
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Incidence of incisional hernia
研究概览
简要总结
The aim of this study is to investigate the effect of the implantation of an Ultrapro® Mesh as prevention of incisional hernia after elective open abdominal aortic aneurysm repair. According to the literature these patients have an increased risk for an incisional hernia. By the implantation of an artificial mesh into the abdominal wall during the first abdominal aortic aneurysm repair, the risk can be reduced dramatically. In small feasibility studies incisional hernia rates as low as 0% have been achieved.
Patients scheduled for elective open abdominal aortic aneurysm repair will be randomized into two groups, one receiving an onlay mesh, the other conventional wound closure with sutures.
详细描述
Prospective randomized controlled study with two study arms.
Arm 1: Abdominal wall will be closed with a prophylactic mesh implantation in onlay technique after elective open abdominal aortic aneurysm repair.
Arm 2: Abdominal wall will be closed with standard sutures (without mesh implantation)
After the patients gave their informed consent to participate in the study, they will be randomized to one of the two treatment arms. Allocation is carried out based on a prepared randomization list.
Primary endpoint is the rate of incisional hernias within the follow-up period of 2 years. Secondary endpoints are postoperative complications and adverse events during the follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Patient scheduled for elective or early elective open repair of aortic aneurysm
排除标准
- •Emergency surgery
- •EVAR (endovascular procedure)
- •Patients with previous midline laparotomy
- •Patients with in situ abdominal mesh after previous hernia repair
- •Patients with large diastasis of abdominal wall
- •Allergy to penicillin
- •Women before menopause (mesh can interfere with potential future pregnancies)
结局指标
主要结局
Incidence of incisional hernia
时间窗: 24 months
次要结局
- operation time(4 hours)
- Rate of adverse events(24 months)
- Rate of postoperative complications(7 days)
研究者
Ignazio Tarantino
M.D.
Cantonal Hospital of St. Gallen