Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04726488 |
| Other study ID # |
Periareolar Minimally Invasive |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 2021 |
| Est. completion date |
February 2023 |
Study information
| Verified date |
January 2021 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Overall Goal: To study the feasibility and safety of "periareolar minimally invasive surgery"
protocol in patients undergoing periareolar minimally invasive surgery vs. Control group
(inframammary approach).
- Objective1: Test the hypothesis that, the periareolar approach is more feasible and
safer than the inframammary approach.
- Objective2: Identify risk factors that are predictive of the need for periareolar
approach.
- Objective3: Assess outcomes and postoperative results of both periareolar and
inframammary approach.
Description:
The first successful cardiac operation was performed in 1896, in Germany by Rehn (1),
followed by the first successful cardiac valve operation in 1912 by Tuffier (2) and the first
successful mitral valve operation in 1923 (3).
In 1956, Lillehei repaired multiple valvular lesions through a right thoracotomy using
cardiopulmonary bypass (4).
In the 1990s, the success of laparoscopic operations in general surgery renewed an interest
in minimally invasive approaches for cardiac surgery. Navia and Cosgrove (5) and Cohn et al.
(6) performed the first minimally invasive valve operations via the right parasternal and
transsternal approaches. Remarkably, excellent exposure was achieved through smaller
incisions, thereby making complex valve repair possible and safe.
In 1996, Carpentier et al. (7) performed the first video-assisted mitral valve repair through
a minithoracotomy using ventricular fibrillation. With more experience, video-assisted,
2-dimensional endoscopes and robotics were introduced by Carpentier (7) and Chitwood (8,9).
In 2009 Poffo et al (10,11) describe a new technique of minimally invasive cardiac surgery.
He and his colleagues adopting periareolar access for mitral valve surgery since 2006 and
published this technique in 2009.
However, due to its feasibility and safety, was soon incorporated as an ideal access for
other cardiac pathologies such as tricuspid valve disease, atrial septal defect, atrial
fibrillation, and pacemaker leads endocarditis. This led Poffo and his colleagues to publish
a long-term result on his technique in 2018 supporting the use of periareolar access as a
routine surgical technique for correction of several cardiac pathologies, especially in
women. (12)
