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

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

Study Overview

• Status: Completed
• Conditions: Minimal Invasive Cardiac Surgery; Limited Right Anterior Thoracotomy for Mitral Valve Replacement
• Intervention / Treatment: Procedure: mitral valve replacement through limited right anterior thoractomy; Procedure: mitral valve replacement through median sterntomy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El sharkia
    • Zagazig, El sharkia, Egypt
      • Mohamed Samy Abdalla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Limited Right Anterior Thoracotomy; mitral valve replacement through minimal invasive approach	Procedure: 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.
Active Comparator: median sternotomy; mitral valve replacement through traditional median sterntomy approach	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of skin incision (cosmotic scar)	measured by centimetre by ruler	1 week after surgery
post operative pain threshold (Visual analog scale (VAS):0 to 10 assess pain from no pain-mild -moderate- sever-worst pain possible	measured by universal pain assessment tool	5 days after surgery
wound satisfaction scale (quality of life questionnaire)	modified Likert scale for wond satisfaction:(very dissatisfied,dissatisfied,neutral, satisfied,very satisfied)	2 weeks after surgery

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Mohamed Sa Abdalla, lecturer, cardiothoracic surgery department-faculty of medecine-Zagazig univeristy-Egypt

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Actual): May 20, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: mitral valve replacement; Limited Right Anterior Thoracotomy; median sterntomy
• Other Study ID Numbers: ZU-IRB # 9413-13-4-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No