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Completed

NCT Number: NCT06869980

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed Samy Abdalla

Zagazig, Sharqia Province, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. length of skin incision (cosmotic scar)

    Time frame: 1 week after surgery

    measured by centimetre by ruler

  2. post operative pain threshold (Visual analog scale (VAS):0 to 10 assess pain from no pain-mild -moderate- sever-worst pain possible

    Time frame: 5 days after surgery

    measured by universal pain assessment tool

  3. wound satisfaction scale (quality of life questionnaire)

    Time frame: 2 weeks after surgery

    modified Likert scale for wond satisfaction:(very dissatisfied,dissatisfied,neutral, satisfied,very satisfied)

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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