Morbidity of Conventional and No-touch Saphenectomy in Coronary Artery Bypass Grafting, a Randomized Non-inferiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Demonstrate the non-inferiority of the "no touch" technique over the conventional technique in terms of wound morbidity.
研究概览
简要总结
A clinical research project will be carried out that will consist of a non-inferiority study. The objective is to compare the morbidity of two different surgical techniques for the extraction of the internal saphenous vein, intended to be used as a conduit in coronary bypass.
详细描述
Current clinical trials have shown that the no-touch saphenectomy technique has had a positive impact on the short- and long-term patency of coronary bypass, compared to the conventional extraction technique. It is important to highlight that the conventional technique is the most used in our country (Uruguay, South America), while the "no touch" has fallen into disuse.
Given this disparity in the application of the techniques, it is considered essential to compare both methods in terms of morbidity. For this purpose, a prospective randomized clinical trial will be carried out.
The primary objective is to demonstrate the non-inferiority of the "no touch" technique over the conventional technique in terms of wound morbidity in patients undergoing coronary revascularization, within a non-inferiority margin. Defining morbidity as the combined result of local infection, hematoma, blisters, secretions, necrosis, wound dehiscence, paresthesias, pain and functional impotence.
The investigators will seek to achieve as a specific objective the incidence of each of the study factors: local infection, hematoma, blisters, secretions, necrosis, wound dehiscence, paresthesias, pain, functional impotence and then compare them between both groups at different times.
The anatomopathological study of some of the saphenous vein preparations, one "no touch" and the other conventional, will also be carried out using optical microscopy and ultrastructural comparisons using transmission electron microscopy.
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
- Double (Participant, Investigator)
盲法说明
The patient will not know which group he was assigned to, and the researcher who will evaluate the patients postoperatively will not know either, only the surgeon at the time of performing block randomization prior to surgery.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing coordination coronary revascularization surgery, in which it is necessary to use the internal saphenous vein as a conduit.
排除标准
- •Emergency surgeries.
- •Poor metabolic control (HbA1c > 6.5%).
- •Chronic venous insufficiency or chronic obstructive arteriopathy of the lower limbs.
- •Type II obesity (BMI>35).
结局指标
主要结局
Demonstrate the non-inferiority of the "no touch" technique over the conventional technique in terms of wound morbidity.
时间窗: 1 week, 1 month, 6 months
Our primary objective will be to demonstrate the non-inferiority of the "no touch" technique over the conventional technique in terms of wound morbidity in patients undergoing coronary revascularization, within a non-inferiority margin. Defining morbidity as the combined result of local infection, hematoma, blisters, secretions, necrosis, wound dehiscence, paresthesias, pain and functional impotence.
次要结局
- Incidence of local infection, hematoma, flictena, secretions, necrosis, wound dehiscence, paresthesia, pain, functional impotence and then compare them between both groups at different times.(1 week, 1 month, 6 months)