Prospective Randomized Comparison of Open Versus Laparoscopic Management of Splenic Artery Aneurysms. A Ten-Year Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Overall postoperative morbidity rate
研究概览
简要总结
The purpose of this study is compare two different surgical treatments of splenic artery aneurysms: open and laparoscopic approach.
详细描述
Laparoscopy has not spread into vascular surgery as it has in other surgical branches and still remains in the hands of a minority of surgeons. Splenic artery aneurysm (SAA) is an exception to the rule: an easy-to-reach position and relatively safe control favour the progressive diffusion of laparoscopic techniques.
An increasing number of cases is managed by minimally invasive surgery originating a number of case reports and small series published in recent literature. These papers are unanimous in signalling the feasibility, safety and effectiveness of laparoscopic technique as well as its appreciation by patients -often young females- who harbour the disease. However, perplexities still remain concerning the real potential of laparoscopy in this specific field, in particular considering the spectrum of technical solutions to be performed, the splenectomy rate and the feasibility and results of reconstructive surgery.
The low incidence of the disease justifies the low number of published laparoscopic series enrolling an adequate number of patients and, in particular, the absence of papers comparing open and laparoscopic techniques.
This study reports the first prospective randomized comparison of the different surgical techniques.
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
- •Splenic artery aneurysm with diameter greater than 2 cm
- •Splenic artery aneurysm with diameter smaller than 2 cm if risk factors for rupture are associated (child bearing age, pregnancy, blister or saccular shape, increasing diameter)
排除标准
- •Complex aneurysm involving the celiac trunk
- •American Society of Anesthesiologists (ASA) Score > 3
结局指标
主要结局
Overall postoperative morbidity rate
时间窗: During and after hospital stay, an expected average of 50 months
According to Dindo-Clavien classification of postoperative complication, we collect in a prospective way and classify all the possible complication by direct clinical evaluation and additional blood sample, imaging or endoscopy if required.
次要结局
- Resumption of oral diet(Partcipants will be followed for the duration of hospital stay, an expected average of one week)
- Intra-abdominal surgical drain removal time(Partcipants will be followed for the duration of hospital stay, an expected average of one week)
- Hospital stay length(Partcipants will be followed for the duration of hospital stay, an expected average of one week)