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

Study Overview
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Brief Summary
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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

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

Conditions
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Minimally Invasive Mitral Valve Surgery

Intervention / Treatment
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* Procedure: mitral valve replacement through full sternotomy approach.
* Procedure: mitral valve replacement through right mini thoracotomy approach.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with isolated rheumatic mitral valve disease in need for mitral valve replacement. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>patients who will undergo mitral valve replacement through full sternotomy approach | Procedure: mitral valve replacement through full sternotomy approach.<br>* compare between Minimally Invasive Mitral Valve Replacement and Conventional Approach<br>|
| Active Comparator: Group B<br>patients who will undergo mitral valve replacement through right mini thoracotomy approach | Procedure: mitral valve replacement through right mini thoracotomy approach.<br>* compare between Minimally Invasive Mitral Valve Replacement and Conventional Approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative pain | pain score | immediately post operative | 
| total hospital stay in days | days in hospital included ICU stay and ward stay | maximum 7 days |