Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries

NCT ID: NCT06696560

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2028-01-30

Brief Summary

To compare intraoperative and immediate postoperative outcomes of mini-sternotomy versus mini-thoracotomy as less invasive techniques in patients with isolated aortic valvular and subvalvular disease requiring surgery according to inclusion criteria.

Detailed Description

1. It has been demonstrated that minimally invasive aortic valve replacement (MIAVR) approaches are safe and effective for the treatment of aortic valve diseases. To date, the main advantage of these approaches is represented by the reduced surgical trauma, with a subsequent reduced complication rate and faster recovery. This makes such approaches an appealing choice also for frail patients [obese, aged, chronic obstructive pulmonary disease (COPD)(1).

2. Minimally invasive aortic valve replacement (MIAVR) has been increasingly accepted in the surgical community as a potential alternative to conventional sternotomy, with advantages of reduced trauma, improved cosmotic and reduced hospitalization(2).

3. The Mini sternotomy (MS) approach represents the most common technique used for Minimally invasive AVR. The MS approach is achieved through 6 to 10cm midline vertical skin incision, performing a partial J sternotomy at the third to fifth intercostal space (3). MIAVR via right mini thoracotomy (RT) is performed through five to seven cm skin incision placed at the level of the second intercostal space without rib resection. After sacrificing the right internal thoracic artery(4).

4. Despite these excellent results, there have been an increasing number of cases performed via minimally invasive aortic valve replacement (MIAVR). This approach has now become an established alternative to FS in order to reduce the "invasiveness" of the surgical procedure, while maintaining the same efficacy, quality and safety of a conventional approach (5).

Conditions

Rheumatic Heart Disease With Valvulitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries.

Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries.

Group Type: OTHER

Minimal Invasive Approaches in Aortic surgeries.

Intervention Type: OTHER

Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries

Interventions

Minimal Invasive Approaches in Aortic surgeries.

Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients with isolated Aortic valve and subvalvular disease.

2. sexes included with acceptance of patients to participate in this study and approval of Ethical Committee.

Exclusion Criteria

1. Patients ages who less than 16 yrs and more than 60yrs.

2. Emergent open heart surgery.

3. Patients with current Infective endocarditis.

4. Patients with chest deformity pectus excavatum or carinatum due to difficult access.

5. The patient refused to sign the informed consent to participate in the research.

6. Patients with Aortic root abscess or Aortic dilatation at root or ascending parts.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yahia Abd almonem Sayed

OTHER

Sponsor Role: lead

Responsible Party

Yahia Abd almonem Sayed

Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries.

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

AssiutU 1

Identifier Type: -

Identifier Source: org_study_id