Thoracic and Cardiovascular Department, Division of Cardiac Surgery, San Giovanni Battista of Turin Hospital, University of Turin, Corso Bramante 84, 10126 Turin, Italy.
Trials. 2011 Nov 18;12:243. doi: 10.1186/1745-6215-12-243.
In coronary artery bypass grafting surgery, arterial conduits are preferred because of more favourable long-term patency and outcome. Anyway the greater saphenous vein continues to be the most commonly used bypass conduit. Minimally invasive endoscopic saphenous vein harvesting is increasingly being investigated in order to reduce the morbidity associated with conventional open vein harvesting, includes postoperative leg wound complications, pain and patient satisfaction. However, to date the short and the long-term benefits of the endoscopic technique remain controversial. This study provides an interesting opportunity to address this gap in the literature.
METHODS/DESIGN: Endoscopic Saphenous harvesting with an Open CO2 System trial includes two parallel vein harvesting arms in coronary artery bypass grafting surgery. It is an interventional, single centre, prospective, randomized, safety/efficacy, cost/effectiveness study, in adult patients with elective planned and first isolated coronary artery disease. A simple size of 100 patients for each arm will be required to achieve 80% statistical power, with a significant level of 0.05, for detecting most of the formulated hypotheses. A six-weeks leg wound complications rate was assumed to be 20% in the conventional arm and less of 4% in the endoscopic arm. Previously quoted studies suggest a first-year vein-graft failure rate of about 20% with an annual occlusion rate of 1% to 2% in the first six years, with practically no difference between the endoscopic and conventional approaches. Similarly, the results on event-free survival rates for the two arms have barely a 2-3% gap. Assuming a 10% drop-out rate and a 5% cross-over rate, the goal is to enrol 230 patients from a single Italian cardiac surgery centre.
The goal of this prospective randomized trial is 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.The expected results are of high clinical relevance and will show the safety/efficacy or non-inferiority of one treatment approach in terms of vein harvesting for coronary artery bypass grafting surgery.
www.clinicalTrials.gov NCT01121341.
在冠状动脉旁路移植术中，由于动脉移植物具有更好的长期通畅性和结果，因此首选动脉移植物。然而，大隐静脉仍然是最常用的旁路移植物。为了降低传统开放静脉采集相关的发病率，包括术后腿部伤口并发症、疼痛和患者满意度，微创内镜大隐静脉采集越来越受到关注。然而，到目前为止，内镜技术的短期和长期益处仍存在争议。这项研究为解决文献中的这一空白提供了一个有趣的机会。
方法/设计：冠状动脉旁路移植术中的开放式 CO2 系统内镜大隐静脉采集试验包括冠状动脉旁路移植术中的两条平行静脉采集臂。这是一项干预性、单中心、前瞻性、随机、安全性/有效性、成本/效果研究，纳入了择期计划和首次孤立性冠状动脉疾病的成年患者。每个臂需要 100 例简单大小的患者，才能达到 80%的统计效力，显著水平为 0.05，以检测大多数制定的假设。假设传统臂的六周腿部伤口并发症发生率为 20%，而内镜臂的发生率低于 4%。以前引用的研究表明，在第一年静脉移植物失败率约为 20%，在最初的六年中每年闭塞率为 1%至 2%，内镜和传统方法之间几乎没有差异。同样，两支手臂的无事件生存率结果相差仅 2-3%。假设 10%的脱落率和 5%的交叉率，目标是从意大利单一心脏手术中心招募 230 名患者。
这项前瞻性随机试验的目的是比较和测试开放式 CO2 内镜采集系统与传统静脉采集相比，在伤口愈合、生活质量、安全性/有效性、成本效益、短期和长期结果以及静脉移植物通畅性方面的改善。预期结果具有很高的临床相关性，并将显示一种治疗方法在冠状动脉旁路移植术中静脉采集方面的安全性/有效性或非劣效性。
www.clinicalTrials.gov NCT01121341。
