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

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05504109
Collaborator
(none)
50
1
2
7
7.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: mitral valve replacement through full sternotomy approach.
  • Procedure: mitral valve replacement through right mini thoracotomy approach.
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Minimally Invasive Mitral Valve Replacement Versus Conventional Approach: Comparison of Early Postoperative Outcomes.
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group A

patients who will undergo mitral valve replacement through full sternotomy approach

Procedure: mitral valve replacement through full sternotomy approach.
compare between Minimally Invasive Mitral Valve Replacement and Conventional Approach

Active Comparator: Group B

patients who will undergo mitral valve replacement through right mini thoracotomy approach

Procedure: mitral valve replacement through right mini thoracotomy approach.
compare between Minimally Invasive Mitral Valve Replacement and Conventional Approach

Outcome Measures

Primary Outcome Measures

  1. post-operative pain [immediately post operative]

    pain score

  2. total hospital stay in days [maximum 7 days]

    days in hospital included ICU stay and ward stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
abdelhamed alaaeldin ali, Assistant lecture of cardiothoracic surgery, Sohag University
ClinicalTrials.gov Identifier:
NCT05504109
Other Study ID Numbers:
  • Soh-Med-22-08-12
First Posted:
Aug 17, 2022
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 17, 2022