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Periareolar Approach in Minimally Invasive Cardiac Surgery

Periareolar Approach in Minimally Invasive Cardiac Surgery; New Trend.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04726488
Acronym
PAMI
Enrollment
102
Registered
2021-01-27
Start date
2021-02-28
Completion date
2023-02-28
Last updated
2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periareolar Minimally Invasive Cardiac Surgery

Brief 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.

Detailed 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)

Interventions

PROCEDUREPeriareolar Approach in Minimally Invasive Cardiac Surgery (PAMI Technique)

To study the feasibility and safety of periareolar minimally invasive surgery protocol in patients undergoing periareolar minimally invasive surgery vs. Control group (inframammary approach).

PROCEDUREinframammary approach

To study the feasibility and safety of periareolar minimally invasive surgery protocol in patients undergoing periareolar minimally invasive surgery vs. Control group (inframammary approach).

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

All investigators will be blinded (i.e., closed envelop open in the OR to choose which approach will be performed either periareolar Vs infra-mammary approach in minimally invasive cardiac surgery)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients undergoes mitral or tricuspid valve surgery. * lesion of right side of the heart.

Exclusion criteria

* patients undergoing aortic valve or CABG surgery. * surgery of left side of the heart.

Design outcomes

Primary

MeasureTime frameDescription
Duration of surgery2 hoursstart from skin incision to cardiopulmonary bypass initiation

Secondary

MeasureTime frameDescription
rate of surgical site complicationsthree monthwound infection, dehiscence, seroma

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026