Periareolar Approach in Minimally Invasive Cardiac Surgery (PAMI)

• ClinicalTrials.gov Identifier: NCT04726488
• Recruitment Status: Not yet recruiting
• First Posted: January 27, 2021
• Last Update Posted: January 27, 2021
• Sponsor: Assiut University
• Information provided by (Responsible Party): Mohamed El Adel Sayed Hassanein Sayed, Assiut University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Periareolar Minimally Invasive Cardiac Surgery	Procedure: Periareolar Approach in Minimally Invasive Cardiac Surgery (PAMI Technique); Procedure: inframammary approach	Not Applicable

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)

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• 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)
• Primary Purpose: Treatment
• Official Title: Periareolar Approach in Minimally Invasive Cardiac Surgery; New Trend.
• Estimated Study Start Date: February 2021
• Estimated Primary Completion Date: September 2022
• Estimated Study Completion Date: February 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Periareolar 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).	Procedure: Periareolar 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).
Active Comparator: Inframammary 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).	Procedure: inframammary 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).

Outcome Measures

Primary Outcome Measures :

1. Duration of surgery [ Time Frame: 2 hours ]
   start from skin incision to cardiopulmonary bypass initiation

Secondary Outcome Measures :

1. rate of surgical site complications [ Time Frame: three month ]
   wound infection, dehiscence, seroma

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Mohamed El Adel Sayed Hassanein Sayed, principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT04726488
• Other Study ID Numbers: Periareolar Minimally Invasive
• First Posted: January 27, 2021
• Last Update Posted: January 27, 2021
• Last Verified: January 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No