Clinical trial NCT05504109: Minimally Invasive Mitral Valve Replacement Versus Conventional Approach: Comparison of Early Postoperative Outcomes.
Official title: Minimally Invasive Mitral Valve Replacement Versus Conventional Approach: Comparison of Early Postoperative Outcomes.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Minimally Invasive Mitral Valve Surgery
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: post-operative pain
timeFrame: immediately post operative
measure: total hospital stay in days
timeFrame: maximum 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Falk V, Cheng DC, Martin J, Diegeler A, Folliguet TA, Nifong LW, Perier P, Raanani E, Smith JM, Seeburger J. Minimally invasive versus open mitral valve surgery: a consensus statement of the international society of minimally invasive coronary surgery (ISMICS) 2010. Innovations (Phila). 2011 Mar;6(2):66-76. doi: 10.1097/IMI.0b013e318216be5c.
citation: Vollroth M, Seeburger J, Garbade J, Borger MA, Misfeld M, Mohr FW. Conversion rate and contraindications for minimally invasive mitral valve surgery. Ann Cardiothorac Surg. 2013 Nov;2(6):853-4. doi: 10.3978/j.issn.2225-319X.2013.10.15. No abstract available.
citation: Joshi P, Doshi C, Vinchurkar M, Thosani R, Sagar P, Mahajan V. Minimally invasive combined aortic and mitral valve replacement. Heart Lung Circ. 2011 Apr;20(4):231-3. doi: 10.1016/j.hlc.2010.10.072. Epub 2010 Dec 10.
citation: Schmitto JD, Mokashi SA, Cohn LH. Minimally-invasive valve surgery. J Am Coll Cardiol. 2010 Aug 3;56(6):455-62. doi: 10.1016/j.jacc.2010.03.053.