Endoscopic Versus Open Vein Harvest in Coronary Artery Bypass Grafting. Clinical and CT-angiographic Long-term Result From a Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Patency rates of vein grafts
研究概览
简要总结
Vena saphena magna is still frequently used as graft material in coronary artery bypass grating(CABG, and vein grafts can harvest with either the conventional open technique (Ovh = open vein harvesting), or with less invasive endoscopic techniques (EVH = Endoscopic vein harvesting). The endoscopic techniques have been shown to reduce the incidence of postoperative wound complications while patients are more satisfied with the cosmetic result of the operation on the leg.
Non-randomized studies have raised doubts about patency rates of the vein grafts following EVH compared to OVH, while other studies failed to detect any problems in relation to this. There are only very few data on long-term patency rates from randomized studies.
The purpose of this study is to investigate clinical outcome and patency rates of the vein grafts following either EVH and OVH in 132 patients who underwent CABG for 4-7 years ago as part of a randomized study investigation wound complications. A cost-effectiveness analysis will also be performed.
The hypothesis is: Patency rates following EVH are worse compared to OVH in CABG 4-7 years postoperatively.
详细描述
Background
Vena saphena magna is frequently used as graft material in coronary artery bypass grafting (CABG. Vein grafts can be harvested with conventional open technique (OVH = open vein harvesting), or with various endoscopic less invasive techniques (EVH = Endoscopic vein harvesting). The endoscopic techniques have been shown to reduce the incidence of postoperative wound complications and patients are more satisfied with the cosmetic surgery results.
Non-randomized trials, however, cast doubt on the patency rates of the vein grafts following EVH compared to OVH, while other studies including one randomized trial failed to detect any problems regarding this. There are no data regarding long-term patency rate following EVH.
It is therefore valuable to conduct a secondary follow-up among CABG patients who 4-7 years ago were included in a randomized trial focusing on wound complications from the leg. Although the study was not designed to evaluate the clinical results and patency rates of vein graft, such a study may still contribute with important knowledge because the results will come from a randomized patient cohorts, in contrast to results from most other studies.
Purpose
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 43 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who participated in the previous randomized study
- •Informed consent from the patient
排除标准
- •Survival until date of reexamination
- •No informed consent
- •CT scan of the heart will not be performed in patients with if: atrial fibrillation,p-creatinin >120 micromol/l, allergy to contrast, pregnancy, lactating.
结局指标
主要结局
Patency rates of vein grafts
时间窗: 5-7 years postoperatively
次要结局
- recurrence of angina pectoris(5-7 years postoperatively)
研究者
Jan Jesper Andreasen, MD, PhD
Professor, MD, PhD
Aalborg University Hospital