Norwegian Laparoscopic Aortic Surgery Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Postoperative complications
研究概览
简要总结
Patients with severe atherosclerotic occlusive disease can be operated on with an aortobifemoral bypass(ABFB)through a median laparotomy. Since 1993, this operation has also been performed laparoscopically. The laparoscopic ABFB operation claims to be minimally invasive as compared to the open ABFB. The cohort studies published so far have shown that although a longer operation time with the laparoscopic procedure as compared to the open surgery, the patients have a shorter hospital stay, lesser perioperative bleeding, fewer systemic complications, and earlier convalescence.
However, no randomized control trial has yet been published to compare the two procedures.
In the NLAST-study, which is a multicenter randomized control trial, the patients with TASC type D atherosclerotic lesions shall be randomized to either totally laparoscopic aortobifemoral bypass operation (LABFB)or an open ABFB operation.
详细描述
The primary endpoint of the study is post-operative complications defined as systemic and local complications, including vascular complications e.g., graft infection, thrombosis, etc.
Secondary endpoints are as follows,
- health-related quality of life, examined and evaluated with the help of pre and post-operative surveys performed with the help of SF36v2 questionnaire and EQ5D5L.
- perioperative stress response (during operation) measured/analyzed with the help of stress hormones changes
- perioperative inflammatory response
- cost-utility analysis
- cost differences
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aortoiliac occlusive disease (TASC Type D lesions)
排除标准
- •Active cancer disease
- •Acute critical limb ischemia
- •Prior major abdominal surgery
- •Heart failure (Ejection fraction <40%
研究组 & 干预措施
Open aortobifemoral bypass
Patients with aortoiliac occlusive disease (only, TASC Type D lesions) shall be randomized to either laparoscopic aortobifemoral bypass or open aortobifemoral bypass operation.
干预措施: Laparoscopic aortobifemoral bypass (Procedure)
Laparoscopic aortobifemoral bypass
Patients with aortoiliac occlusive disease (only, TASC Type D lesions) shall be randomized to either laparoscopic aortobifemoral bypass or open aortobifemoral bypass operation.
干预措施: Laparoscopic aortobifemoral bypass (Procedure)
结局指标
主要结局
Postoperative complications
时间窗: 2.9 years
Postoperative complications during a mean follow-up period of 2.9 years are the primary outcome measure of NLAST.
次要结局
- health related quality of life(3 months postoperatively)
研究者
Syed Sajid Hussain Kazmi
Consultant Surgeon
Oslo University Hospital