An observational study in Mitral Valve Disease, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-26.
Sponsored by Assiut University · Observational
To identify the best approach for mitral valve replacement to decrease risk of bleeding and restrict blood transfusion and its complication.
Mitral valve disease is the most common form of the valvular heart disorders including mitral regurgitation and mitral stenosis. Surgical treatment includes repair and replacement with different approaches as conventional median sternotomy or minimally invasive approaches.
Since minimally invasive mitral valve surgery (MMVS) was first described in the mid-to-late 1990s by pioneer surgeons Alain Carpentier and Randolph Chitwood, the techniques have evolved to include mini-thoracotomy, port-access thoracoscopic, partial sternotomy, and robotic. Right lateral mini-thoracotomy has become the standard approach for mitral valve surgery in many centers. These approaches may result in less surgical trauma, blood transfusions, and pain, thereby leading to a shorter hospital stay and faster return to daily activities. A reduction in postoperative hemorrhage and transfusion requirements have been suggested as a potential advantage of minimally invasive valve surgery. This benefit is important given the significant morbidity and mortality associated with transfusions and re-exploration for bleeding. Observational studies suggested that patients undergoing MMVS required fewer units of pRBCs transfused per patient and patients were at lower risk of transfusion. RCTs did not reach statistical significance. So, more studies were required to reach a definite conclusion.
Through this study our aim is to evaluate postoperative bleeding and needs for blood transfusion in conventional median sternotomy mitral valve replacement in comparison to minimally invasive approach.
Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients aged between 18-80 years old, males or females, undergoing mitral valve replacement through minimally invasive or median sternotomy at Assiut Cardiothoracic surgery department.
Exclusion Criteria:
Procedure: Mitral valve replacement
Procedure: Mitral valve replacement
Mitral valve replacement through median sternotomy and minimally invasive approach
bleeding
Amount of post operative bleeding per drains
Time frame: Baseline
Blood transfusion
Amount of blood products transfused
Time frame: Baseline
Reexploration
Number of patients re-explored due to massive bleeding
Time frame: Baseline
Complications of blood transfusion
Complications of blood transfusion
Time frame: Baseline
ICU stay
Numbered of days patient stayed in ICU
Time frame: Baseline
Cost effectiveness
Financial aspect
Time frame: Baseline
No study locations are listed for this record.
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Assiut University