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临床试验/NCT05504109
NCT05504109Unknown不适用

Minimally Invasive Mitral Valve Replacement Versus Conventional Approach: Comparison of Early Postoperative Outcomes.

Sohag University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
post-operative pain

研究概览

简要总结

The term minimally invasive mitral valve surgery has been reported (MIMVS) by American Heart Association and referred to a collection of new techniques. All of these new techniques aiming to reduce surgical trauma by minimizing surgical incision, modified perfusion methods and use of new instruments . The right anterior mini-thoracotomy is the most common approach, next to it the lower mini-sternotomy approach, then the parasternal incision or the left posterior thoracotomy approach .

Technically MIMVS is more complex, requires a special learning curve and associated with higher Incidence of neurological events, aortic dissection, groin complications and infection despite all these benefits . MIVS also has controversies among cardiac surgeons, because it makes the exposure worse and requires a more complex surgery, which may lead to a less satisfying effect

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
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with isolated rheumatic mitral valve disease in need for mitral valve replacement.

排除标准

  • Redo mitral valve replacement.
  • Emergency mitral valve replacement (non-rheumatic cases).
  • Patients who have combined other valve diseases e.g. (severe Aortic Regurgitation).
  • Patients need Tricuspid valve repair or replacement.
  • Severely calcified mitral valve disease (mitral annular calcification).

结局指标

主要结局

post-operative pain

时间窗: immediately post operative

pain score

total hospital stay in days

时间窗: maximum 7 days

days in hospital included ICU stay and ward stay

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

abdelhamed alaaeldin ali

Assistant lecture of cardiothoracic surgery

Sohag University

研究点 (1)

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