跳至主要内容
临床试验/NCT02446522
NCT02446522已完成4 期

Comparative Results of Endoscopic and Open Methods of Vein Harvesting for Coronary Artery Bypass Grafting: a Prospective Randomized Parallel-group Trial.

Meshalkin Research Institute of Pathology of Circulation0 个研究点目标入组 228 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
228
主要终点
postoperative wound complications

研究概览

简要总结

There is no shared vision relating to integrity and quality of the conduit after the impact on the vein wall during vein harvesting. In this connection, the investigators studied the initial state of the venous conduit, interoperation damages of the vein and postoperative wound complications while using two methods of GSV harvesting.

详细描述

The great saphenous vein (GSV) remains one of the most commonly used conduits due to its ease of harvest, availability and versatility [1] Traditional harvesting of GSV is open vein harvesting, which involves an extended leg incision. This technique is associated with a significant morbidity and wound complications occur in 2-24% of cases.

Minimally invasive techniques endoscopic vein harvesting (EVH), have therefore been developed to reduce post-CABG leg wound complications. Last time the endoscopic vein harvesting is the method of choice in many centers as it allowed reduction of post-surgical complications as compared to the open method. Although long-term graft patency following EVH has been questioned cohort studies have reported that the technique is safe and effective.

The possibility to use lymphoscintigraphy for evaluation of lower limb lymphatic system after vein harvesting for the coronary artery bypass surgeries was reported before. Nevertheless, the state of the lymphatic system after vein harvesting remains to be poorly studied.

Currently, there is no shared vision relating to integrity and quality of the conduit after the impact on the vein wall during vein harvesting. In this connection, the investigators studied the initial state of the venous conduit, interoperation damages of the vein and postoperative wound complications while using two methods of GSV 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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • subjects with multivascular lesion of the coronary artery to whom coronary artery bypass surgery was indicated.

排除标准

  • urgent coronary artery bypass surgery with unstable haemodynamics;
  • previous coronary artery bypass surgery;
  • chronic venous insufficiency С4-С6 under СЕAR classification;
  • previous limb surgeries.

结局指标

主要结局

postoperative wound complications

时间窗: during 30 day after operation

all cases postoperative wound complications

次要结局

未报告次要终点

研究者

发起方
Meshalkin Research Institute of Pathology of Circulation
申办方类型
Network
责任方
Sponsor

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