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

Not Applicable

• Conditions: Minimally Invasive Mitral Valve Surgery
• Interventions: Procedure: mitral valve replacement through full sternotomy approach.; Procedure: mitral valve replacement through right mini thoracotomy approach.

• Registration Number: NCT05504109
• Lead Sponsor: Sohag University

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-15
• Last Update Submitted: 2022-08-15
• Study First Posted: 2022-08-17
• Last Update Posted: 2022-08-17
• Study Start: 2022-09-01
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	mitral valve replacement through full sternotomy approach.	patients who will undergo mitral valve replacement through full sternotomy approach
Group B	mitral valve replacement through right mini thoracotomy approach.	patients who will undergo mitral valve replacement through right mini thoracotomy approach

Primary Outcome Measures

Name	Time	Method
post-operative pain	immediately post operative	pain score
total hospital stay in days	maximum 7 days	days in hospital included ICU stay and ward stay

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt