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

NCT06869980 | Completed DMC

• 1 other identifier: ZU-IRB # 9413-13-4-2022
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

mitral valve replacement; Limited Right Anterior Thoracotomy; median sterntomy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Limited Right Anterior Thoracotomy

EXPERIMENTAL

mitral valve replacement through minimal invasive approach

Procedure: mitral valve replacement through limited right anterior thoractomy

median sternotomy

ACTIVE COMPARATOR

mitral valve replacement through traditional median sterntomy approach

Procedure: mitral valve replacement through median sterntomy

Interventions

mitral valve replacement through limited right anterior thoractomy 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.

Limited Right Anterior Thoracotomy

mitral valve replacement through median sterntomy 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.

median sternotomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Mohamed Samy Abdalla

Zagazig, Sharqia Province, Egypt

Location

Study Officials

• Mohamed Sa Abdalla, lecturer

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 11, 2025
• Study Start: May 10, 2022
• Primary Completion: May 20, 2023
• Study Completion: September 15, 2023
• Last Updated: March 11, 2025

Record last verified: 2025-01

Locations

EG (1)