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临床试验/NCT04078100
NCT04078100Unknown不适用

Transseptal Approach Versus Conventional Left Atrial Approach for Mitral Valve Procedures

Assiut University0 个研究点目标入组 100 人开始时间: 2019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
100
主要终点
re-operation

研究概览

简要总结

Study Objectives/Specific Aims Overall Goal: To compare between transseptal approach and the conventional left atrial approach for mitral valve procedures.

  • Objective 1: Assess the intraoperative approach related criteria in valve exposure, cardiopulmonary bypass time and intraoperative complications.
  • Objective 2: Assess the outcomes and postoperative results.

详细描述

Mitral valve diseases are considered among the most prevalent valvular heart diseases that necessitate surgical intervention.

as the Modern international guidelines substantially recommend mitral valve repair whenever possible there is significant decrease in mitral valve replacement rates.

Cardiothoracic surgeons have to face the problem of Making a decision regarding mitral valve repair, reconstruction or replacement which requires excellent valve exposure for precise anatomical definition and manipulation taking in mind cases with specific anatomical challenges.

Since the beginning of modern cardiac surgery only two basic approaches to the mitral valve have been described by Effler who wrote in 1958 " the actual entry into the left atrium may be accomplished in either of two ways : through the Fossa Ovalis by way of the right atrium or through the posterior interatrial groove " Nowadays median sternotomy is still the most commonly used incision for mitral valve surgery which allows the best exposure for the valve through transseptal incision or through Sandergaard's groove.

Although the latter approach is the preferred method for most surgeons the transseptal approach has been revisited in more recent years in various forms by those seeking better exposure of mitral valve especially in cases with difficult anatomy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients underwent mitral valve replacement, mitral valve repair, redo mitral valve replacement, combined mitral and tricuspid procedures, combined mitral surgery and coronary arteries bypass graft at cardiothoracic surgery department Assiut University Hospital.

排除标准

  • •Patients with congenital mitral valve diseases .
  • •patient refused to sign the informed consent to be a part in the research .

结局指标

主要结局

re-operation

时间窗: with in the first 24 hrs post operative.

re exploration through the same incision site to stop bleeding.

whole operation time.

时间窗: intraoperative registration.

period of time from skin incision to skin closure in open heart surgery.

ischemic time

时间窗: intraoperative registration.

period of time from applying the aortic cross clamp till its removal in open heart surgeries during which there is no blood flow in the coronary arteries and the heart is ischemic.

次要结局

  • Postoperative arrhythmias.(within the first week post operative.)
  • Hospital stay.(up to three months)

研究者

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

Beshoy Allam Moris

Dr.

Assiut University

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