Prophylactic Mesh Implantation After Abdominal Aortic Aneurysm Repair. A Prospective, Randomised, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 18
- 主要终点
- Herniation rate
研究概览
简要总结
AIDA Study is a prospective, multicentre, randomized, controlled clinical investigation with patients undergoing median laparotomy for Abdominal Aortic Aneurysm (AAA) repair.
The primary objective of the clinical investigation is to test the hypothesis that insertion of an Optilene® Mesh Elastic mesh - a monofilament, light-weight, large pore sized, polypropylene mesh manufactured by Aesculap AG - is superior to suturing alone and will reduce the hernia formation rate within the first 2 years.
A reduction from 30% to 10% of the patient population is assumed.
详细描述
One of the late complications of the elective surgery of an Abdominal Aortic Aneurysms (AAA) is the formation of an incisional hernia following the AAA repair.
The high frequency of incisional hernia formation in the AAA patients suggests the presence of a structural defect within the fascia.
As a result of these information and that obtained from a small pilot study using mesh prophylactically in high risk group of patients, the concept of using a mesh prophylactically for AAA repairs seems an area worth further exploration.
Owing to the availability of the new generation of meshes with proven good biocompatibility it would seem that this could be a viable means of reducing the herniation rate and therefore re-operation in this high risk population.
Within the investigation Patients requiring elective surgical repair of an AAA will be randomized in one of the following three different groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Male and female patients >18 years of age.
- •Patients undergoing an elective surgery for AAA repair.
- •Patients who currently have no malignant disease requiring therapy.
- •Patients who are able to fulfill all clinical investigation requirements
- •Patients who have provided written informed consent.
排除标准
- •Patients who require median laparotomy for AAA repair as an emergency procedure.
- •Expected length of fascia incision > 30 cm.
- •Patients with coagulopathy
- •Patients who have had previous median laparotomy and/or laparotomy crossing the incision necessary for AAA laparotomy.
- •Patients with current immunosuppressive therapy (>40 mg corticoid/day or azathioprine).
- •Chemotherapy within the last 4 weeks.
- •Radiotherapy on the treated region within the last 2 months.
- •Pregnant and breast-feeding women.
- •Known allergy against ingredients of the investigational products (polypropylene, poly-4-hydroxybutyrate, polydioxanone).
- •Patients participating in other investigational drug or medical device studies within the preceding 4 weeks.
- •Patients with an ongoing medical condition or social reason that may affect their ability to complete the two years follow-up period.
- •Life expectancy less than 24 months.
- •Severe psychiatric or neurologic disease.
- •Lack of compliance.
- •Drug abuse.
- •Inability to understand and follow the instructions given by the investigator (e.g. dementia, lack of time, insufficient command of language).
结局指标
主要结局
Herniation rate
时间窗: 24 months
As an indicator of efficacy, the reduction of herniation rate will be verified by clinical examination and confirmed by Ultrasound.
次要结局
未报告次要终点