Prevention of Incisional Hernia by Mesh Augmentation After Midline Laparotomy for Aortic Aneurysm Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- To reduce the incidence of incisional hernia 2 years postoperatively after midline laparotomy for treatment of aortic aneurysm from 25% to 5% by mesh augmentation during closure of the laparotomy Incidence of incisonal hernia
研究概览
简要总结
The research hypothesis for this study is to possibly reduce the incidence of incisional hernia 2 years postoperatively after midline laparotomy for treatment of aortic aneurysm from 25% to 5% by mesh augmentation during closure of the laparotomy. The study is designed as a prospective randomised multi-centre trial, randomising patients in 2 groups concerning the surgical technique of the closure of the abdominal wall.
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
- 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
- •All patients undergoing elective Abdominal Aorta Aneurysm treatment through a midline laparotomy are eligible for the trial.
- •All patients should sign the informed consent.
排除标准
- •Patients below 18 years.
- •Pregnancy.
- •Emergency surgery for aortic aneurysm.
- •Presence of mesh in the abdominal wall on the midline from previous operations ASA score 4 or more.
研究组 & 干预措施
1
Conventional laparotomy closure
干预措施: Conventional laparotomy closure (Procedure)
2
Laparotomy closure with mesh augmentation
干预措施: Laparotomy closure with mesh augmentation (Procedure)
结局指标
主要结局
To reduce the incidence of incisional hernia 2 years postoperatively after midline laparotomy for treatment of aortic aneurysm from 25% to 5% by mesh augmentation during closure of the laparotomy Incidence of incisonal hernia
时间窗: 2 years postoperatively
次要结局
- Duration of surgery(After surgery)
- Occurrence of post-operative complications(After 1 month)
- VAS scores of pain at rest(12, 24, 48, 72, 96, 120 hours , 4 weeks and 3 months after surgery)
- Incidence of incisonal hernia(1 year and 5 years after surgery)