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临床试验/NCT06696560
NCT06696560尚未招募不适用

Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries

Yahia Abd almonem Sayed0 个研究点目标入组 52 人开始时间: 2024年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
52
主要终点
Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries.

研究概览

简要总结

To compare intraoperative and immediate postoperative outcomes of mini-sternotomy versus mini-thoracotomy as less invasive techniques in patients with isolated aortic valvular and subvalvular disease requiring surgery according to inclusion criteria.

详细描述

  1. It has been demonstrated that minimally invasive aortic valve replacement (MIAVR) approaches are safe and effective for the treatment of aortic valve diseases. To date, the main advantage of these approaches is represented by the reduced surgical trauma, with a subsequent reduced complication rate and faster recovery. This makes such approaches an appealing choice also for frail patients [obese, aged, chronic obstructive pulmonary disease (COPD)(1).
  2. Minimally invasive aortic valve replacement (MIAVR) has been increasingly accepted in the surgical community as a potential alternative to conventional sternotomy, with advantages of reduced trauma, improved cosmotic and reduced hospitalization(2).
  3. The Mini sternotomy (MS) approach represents the most common technique used for Minimally invasive AVR. The MS approach is achieved through 6 to 10cm midline vertical skin incision, performing a partial J sternotomy at the third to fifth intercostal space (3). MIAVR via right mini thoracotomy (RT) is performed through five to seven cm skin incision placed at the level of the second intercostal space without rib resection. After sacrificing the right internal thoracic artery(4).
  4. Despite these excellent results, there have been an increasing number of cases performed via minimally invasive aortic valve replacement (MIAVR). This approach has now become an established alternative to FS in order to reduce the "invasiveness" of the surgical procedure, while maintaining the same efficacy, quality and safety of a conventional approach (5).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with isolated Aortic valve and subvalvular disease.
  • sexes included with acceptance of patients to participate in this study and approval of Ethical Committee.

排除标准

  • Patients ages who less than 16 yrs and more than 60yrs.
  • Emergent open heart surgery.
  • Patients with current Infective endocarditis.
  • Patients with chest deformity pectus excavatum or carinatum due to difficult access.
  • The patient refused to sign the informed consent to participate in the research.
  • Patients with Aortic root abscess or Aortic dilatation at root or ascending parts.

结局指标

主要结局

Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries.

时间窗: Within 2 years .

To reduce operation duration,so less hospital stay period. Echocardiography assessment intraoperative and postoperative.

次要结局

未报告次要终点

研究者

发起方
Yahia Abd almonem Sayed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yahia Abd almonem Sayed

Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries.

Assiut University

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