Prospective Randomized Study of Two Aortic Surgical Approaches: Mini-laparotomy Versus Mini Lumbotomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 206
- 主要终点
- Intestinal transit recovery
研究概览
简要总结
This study aims to compare the results of two mini invasive surgical approaches in abdominal aortic surgery: mini lumbotomy with retroperitoneal approach versus mini laparotomy with transperitoneal approach. Respiratory and renal functions and recovery of intestinal transit will be assessed after 30 days.
The secondary purpose of this study is to assess the life quality and morbi-mortality at 30 days, as well as at 6 and 12 months.
详细描述
Following abdominal aortic surgery, post-operative outcomes are considered favorable with a rapid recovery of respiratory, renal functions and intestinal transit, with limited cardiac events. Complications are still frequent after the classic open abdominal surgery.
In abdominal aortic surgery, "mini" abdominal incision has been proposed as an alternative to the classic large surgical approach.
Two mini surgical approaches are possible: mini lumbotomy with retroperitoneal approach, and mini laparatomy with transperitoneal approach.
Previous studies have only compared classic versus mini surgical approaches and many are retrospectives studies. Pain control through the mini-incision surgery allowed early mobilization of patients, improved lung function, reduced muscle loss, and favoured intestinal motility.
So far, no study has compared the results of two mini invasive aortic approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Elective abdominal aortic repair.
- •Abdominal aneurysm or occlusive aortic disease requiring intervention.
- •Written consent previously provided by the patient.
- •Affiliation to social security.
- •Preliminary medical examination.
排除标准
- •Hostile abdomen.
- •Juxta renal abdominal aortic aneurysm.
- •Aneurysmal extension to the iliac arteries.
- •Concomitant visceral arteries lesions.
- •Urgent surgery.
- •Contraindication to surgery.
研究组 & 干预措施
Mini laparotomy
Patients with surgical indication to mini invasive aortic repair will be operated after randomisation with transperitoneal approach
干预措施: mini laparotomy (Procedure)
Mini lumbotomy
Patients with surgical indication to mini invasive aortic repair will be operated after randomisation with retroperitoneal approach
干预措施: mini lumbotomy (Procedure)
结局指标
主要结局
Intestinal transit recovery
时间窗: day 30
evaluated by reapparition of gas and transit
Respiratory recovery
时间窗: day 30
evaluated with respiratory function test (Sniff nasal inspiratory pressure, SNIP test)
Renal recovery
时间窗: day 30
evaluated by blood creatinine level, uremia and kalemia
次要结局
- Respiratory recovery(day 5)
- Quality of life assessment(after 1 year)
- Renal recovery(day 5)
- Morbi-mortality(day 30)
- Post-operative pain assessment(day 5)
- Intestinal recovery(day 5)