ESOS (Endoscopic Saphenous Harvesting With an Open CO2 System) Trial: a Prospective Randomized Trial for Coronary Artery Bypass Grafting (CABG) Surgery.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Morbidity hypothesis
研究概览
简要总结
The ESOS (Endoscopic Saphenous harvesting with an Open CO2 System) trial is a prospective randomized trial for coronary artery bypass grafting (CABG) surgery to compare endoscopic open CO2 harvesting system versus conventional vein harvesting.
详细描述
The ESOS (Endoscopic Saphenous harvesting with an Open CO2 System) trial is a prospective randomized trial for coronary artery bypass grafting (CABG) surgery to compare and to test improvement in wound healing, quality of life, safety/efficacy, cost-effectiveness, short and long-term outcomes and vein-graft patency after endoscopic open CO2 harvesting system versus conventional vein harvesting.
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
- •Elective planned CABG surgery
- •First isolated CABG surgery
排除标准
- •Emergency revascularization: patients with hemodynamic instability or requiring inotropic or intra-aortic balloon support
- •Previous cardiac surgery
- •Planned concomitant valve surgery
- •Very varicous veins
- •Previous saphenectomy
- •History of deep vein thrombosis
- •History of suffered trauma on the lower extremity
- •Preoperative legs immobilization
- •Previous leg wound complications
- •Coexisting illness with life expectancy < five years
结局指标
主要结局
Morbidity hypothesis
时间窗: six weeks
When compared to Conventional vein-graft harvesting (CVH) in CABG surgery · Does Endoscopic vein-graft open CO2 system harvesting (EVOH) reduce postoperative wound complications (composite endpoint of all complications or individual complications) assessed with ASEPSIS score?
Patient satisfaction hypothesis
时间窗: six weeks
· Does EVOH improve patient satisfaction, postoperative leg pain and quality of life assessed with VAS score and EUROQol-5D? * To compare health-related quality of life for the two treatment arms (EVOH/CVH) by intention-to-treat * To identify factors in addition to treatment assignment that are associated with variations in quality of life outcomes
Resource utilization hypothesis
时间窗: six weeks
When compared to Conventional vein-graft harvesting (CVH) in CABG surgery · Does EVOH affect resource utilization? * Harvesting time related to the length of vein segments * Harvesting closure time * CABG time * Mobility time * Hospital length of stay * Re-exploration for bleeding due to vein-graft bleed * Readmission for leg wound complications * Need for outpatient wound management resources * To compare total medical costs for the two treatment arms (EVOH/CVH) by intention-to-treat
Quality of vein harvesting hypothesis
时间窗: six weeks
When compared to Conventional vein-graft harvesting (CVH) in CABG surgery * Do EVOH compromises the quality of venous conduit harvested? * Number of harvested veins requiring repair * Number of repairs to each vein * Re-exploration for bleeding due to vein-graft bleed * Histological integrity * Specific secondary subanalysis adjusted for: * Preparation solution of the vein conduit * 20 ml autologous blood * 0,5 ml heparin (5000UI/ml) = 2500 UI * 2 ml papavarine (30mg/ml) = 60 mg * Uncontrolled distension pressure/ no touch technique harvesting
次要结局
- Vein-graft patency hypothesis(six weeks)
- outcome hypothesis(18 months)