Minimal Invasive Cardiac SurgeryNCT06869980
Efficacy of Limited Right Anterior Thoracotomy Versus Median Sternotomy for Mitral Valve Replacement
A study testing mitral valve replacement through limited right anterior thoractomy and mitral valve replacement through median sterntomy in people with Minimal Invasive Cardiac Surgery and Limited Right Anterior Thoracotomy for Mitral Valve Replacement, run by Zagazig University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Minimal Invasive Cardiac Surgery, Limited Right Anterior Thoracotomy for Mitral Valve Replacement
- What is being tested?
- mitral valve replacement through limited right anterior thoractomy and mitral valve replacement through median sterntomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2022to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with acquired isolated mitral valve disease requiring mitral valve replacement > 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- mitral valve replacement through limited right anterior thoractomy, mitral valve replacement through median sterntomy
- Keywords
- mitral valve replacement, Limited Right Anterior Thoracotomy, median sterntomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitral valve replacement through limited right anterior thoractomyProcedure or surgery
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 sterntomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Limited Right Anterior Thoracotomy | Experimental | mitral valve replacement through minimal invasive approach Receives: Procedure: mitral valve replacement through limited right anterior thoractomy |
| median sternotomy | Active comparator | mitral valve replacement through traditional median sterntomy approach Receives: Procedure: mitral valve replacement through median sterntomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of skin incision (cosmotic scar)
measured by centimetre by ruler
Measured: 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
Measured: 5 days after surgery
wound satisfaction scale (quality of life questionnaire)
modified Likert scale for wond satisfaction:(very dissatisfied,dissatisfied,neutral, satisfied,very satisfied)
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start10 May 2022
- Primary completion20 May 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimal Invasive Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mohamed Sa Abdalla, lecturer, Principal investigator, cardiothoracic surgery department-faculty of medecine-Zagazig univeristy-Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869980
- Sponsor's protocol ID
- ZU-IRB # 9413-13-4-2022
- Status last verified
- Jan 2025
- First submitted
- 25 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Limited Right Anterior Thoracotomy Versus Median Sternotomy for Mitral Valve Replacement
- ClinicalTrials.gov ID
- NCT06869980
- Acronym / sponsor ID
- ZU-IRB # 9413-13-4-2022
- Conditions
- Minimal Invasive Cardiac Surgery, Limited Right Anterior Thoracotomy for Mitral Valve Replacement
- Keywords
- mitral valve replacement, Limited Right Anterior Thoracotomy, median sterntomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 10 May 2022 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Limited Right Anterior Thoracotomy | Experimental | Procedure: mitral valve replacement through limited right anterior thoractomymitral valve replacement through minimal invasive approach |
| median sternotomy | Active comparator | Procedure: mitral valve replacement through median sterntomymitral valve replacement through traditional median sterntomy approach |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with acquired isolated mitral valve disease requiring mitral valve replacement > 18 years
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mitral valve replacement through limited right anterior thoractomyThe 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. | Procedure or surgery | Limited Right Anterior Thoracotomy |
| mitral valve replacement through median sterntomyThe 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. | Procedure or surgery | median sternotomy |
Primary outcome
length of skin incision (cosmotic scar)
Time frame: 1 week after surgery
measured by centimetre by ruler
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Sa Abdalla, lecturer principal investigator
cardiothoracic surgery department-faculty of medecine-Zagazig univeristy-Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mitral valve replacement through limited right anterior thoractomy and mitral valve replacement through median sterntomy in people with Minimal Invasive Cardiac Surgery and Limited Right Anterior Thoracotomy for Mitral Valve Replacement, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of skin incision (cosmotic scar) (time frame: 1 week after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.