Efficacy of Limited Right Anterior Thoracotomy Versus Median Sternotomy for Mitral Valve Replacement

NCT ID: NCT06869980

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2023-09-15

Brief Summary

this study compare between two diffrent methods for approach mitral valve in mitral valve replacement throgh opening of the middle of the sternum by saw or through opening between 4th and 5th rib on the right side of the chest without saw

Detailed Description

study the efficacy of mitral valve replacement by median sterntomy versus limited right thoractomy

Conditions

Minimal Invasive Cardiac Surgery; Limited Right Anterior Thoracotomy for Mitral Valve Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Limited Right Anterior Thoracotomy

mitral valve replacement through minimal invasive approach

Group Type: EXPERIMENTAL

mitral valve replacement through limited right anterior thoractomy

Intervention Type: PROCEDURE

The incision is placed just lateral to the nipple over the fourth intercostal space (above the nipple in men and in the inframammary crease in most women) 6-10 cm in length, the pectoralis muscles are mobilized for fourth intercostal space thoracic entry-The pericardium is opened 2-cm ventral to the phrenic nerve under direct vision and carried cephalad to the aortic reflection. The anterior edge of the pericardium is tacked to incision edges using silk sutures-To initiate cardiopulmonary bypass, Cannulation of the femoral artery and femoral vein should be prior to mediastinal dissection-. The ascending aorta occluded with an external clamp. This aortic clamp passed through the thoracotomy incision if we use the aortic cross clamp and the anterograde cardioplegia delivered through a standard cardioplegia cannula secured with purse-string sutures in the ascending aorta.

median sternotomy

mitral valve replacement through traditional median sterntomy approach

Group Type: ACTIVE_COMPARATOR

mitral valve replacement through median sterntomy

Intervention Type: PROCEDURE

The incision is begun approximately 2 cm below the sternal notch and extended approximately 2 cm beyond the distal tip of the xiphoid process and is usually extended with the electrocautery down to the sternal periosteum. A midline approach can be ensured by careful attention to the insertion points of the pectoralis major muscles onto the sternum; the incision should lie directly midway between these insertion points.After sternotomy, the pericardium is opened; the heart is cannulated for cardiopulmonary bypass. Arterial inflow is established by cannulation of the distal ascending aorta near the pericardial reflection. Double venous cannulation of the venae cavae by way of the right atrium is generally employed. In most adults a size 32 Fr cannula in the superior vena cava and a size 34-38 Fr cannula in the inferior vena cava provide excellent venous drainage and easy fit. Encircling of the venae cavae and their generous mobilization aid in the subsequent exposure of the mitral valve.

Interventions

mitral valve replacement through limited right anterior thoractomy

The incision is placed just lateral to the nipple over the fourth intercostal space (above the nipple in men and in the inframammary crease in most women) 6-10 cm in length, the pectoralis muscles are mobilized for fourth intercostal space thoracic entry-The pericardium is opened 2-cm ventral to the phrenic nerve under direct vision and carried cephalad to the aortic reflection. The anterior edge of the pericardium is tacked to incision edges using silk sutures-To initiate cardiopulmonary bypass, Cannulation of the femoral artery and femoral vein should be prior to mediastinal dissection-. The ascending aorta occluded with an external clamp. This aortic clamp passed through the thoracotomy incision if we use the aortic cross clamp and the anterograde cardioplegia delivered through a standard cardioplegia cannula secured with purse-string sutures in the ascending aorta.

Intervention Type: PROCEDURE

mitral valve replacement through median sterntomy

The incision is begun approximately 2 cm below the sternal notch and extended approximately 2 cm beyond the distal tip of the xiphoid process and is usually extended with the electrocautery down to the sternal periosteum. A midline approach can be ensured by careful attention to the insertion points of the pectoralis major muscles onto the sternum; the incision should lie directly midway between these insertion points.After sternotomy, the pericardium is opened; the heart is cannulated for cardiopulmonary bypass. Arterial inflow is established by cannulation of the distal ascending aorta near the pericardial reflection. Double venous cannulation of the venae cavae by way of the right atrium is generally employed. In most adults a size 32 Fr cannula in the superior vena cava and a size 34-38 Fr cannula in the inferior vena cava provide excellent venous drainage and easy fit. Encircling of the venae cavae and their generous mobilization aid in the subsequent exposure of the mitral valve.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with acquired isolated mitral valve disease requiring mitral valve replacement > 18 years

Exclusion Criteria

• patients with Previous cardiac surgery, • Patients less than 18 years, • Patients with other valvular heart lesions (aortic valve or tricuspid valve) , IHD Patients , Obese patients (BMI>35), COPD patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed Sa Abdalla, lecturer

Role: PRINCIPAL_INVESTIGATOR

cardiothoracic surgery department-faculty of medecine-Zagazig univeristy-Egypt

Locations

Mohamed Samy Abdalla

Zagazig, Sharqia Province, Egypt

Countries

Egypt

Other Identifiers

ZU-IRB # 9413-13-4-2022

Identifier Type: -

Identifier Source: org_study_id