Rheumatic Mitral Valve DiseaseNCT05270590
Minimally Invasive Rheumatic Mitral Valve Surgery
An observational study of Rheumatic Mitral Valve Disease, run by Assiut University.
Trial summary
Early outcome of minimally invasive rheumatic mitral valve surgery through periareolar versus submamary approach Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Rheumatic Mitral Valve Disease
- What is being tested?
- minimally invasive rheumatic mitral valve surgery
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 1 Jan 2026
- Phase
- Observational
- 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 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patient undergoing minimal invasive rheumatic mitral valve surgery
Who may be able to join
- Clinical diagnosis of rheumatic mitral valve
- Patient undergoing minimal invasive rheumatic mitral valve surgery
- Patient is willing to comply with all follow-up visits.
- Willing and able to provide written informed consent and comply with study requirements
Who cannot join
- Ischemic heart disease
- Patients need another valve replacement
- Redo mitral valve replacement
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Early Outcome of Minimally Invasive Rheumatic Mitral Valve Surgery Through Periareolar Versus Submamary Approach
Early outcome of minimally invasive rheumatic mitral valve surgery through periareolar versus submamary approach
Read the detailed description
Rheumatic heart valve disease (RHVD) is a post-infectious sequel of acute rheumatic fever resulting from an abnormal immune response to a streptococcal pharyngitis that triggers valvular damage. RHVD is the leading cause of cardiovascular death in children and young adults, mainly in women from low and middle-income countries. It is known that long-term inflammation and high degree of fibrosis leads to valve dysfunction due to anatomic disruption of the valve apparatus.in low and middle-income countries, rheumatic heart valve disease (RHVD) is the leading cause of cardiovascular death in children and young adults When there is severe valvular dysfunction, especially if the patient is symptomatic, surgery is indicated. (1)Traditional mitral valve surgery via a median sternotomy is safe and effective, but it results in a high degree of trauma and a long incision.(2) In the last 2 decades, a minimally invasive (MI) technique has been used widely in cardiac surgery.(3-4) Its prominent advantage in post-surgery recovery and the small incision required makes patients prefer it over a traditional incision.(5-6) Patients underwent Minimal invasive surgery after intravenous anaesthesia combined with general anaesthesia, and their right side was elevated at 30°. After disinfection and draping were performed with sterile protective film fixed to it. Establishing the in vitro pathway: First, venous and arterial access was established. Incision establishment: A 4 to 6 cm incision was opened layer by layer in the chest anterolaterally to the right of the fourth intercostal space (in submamarry vs. peri areolar approach ). A lap-protector was placed. The thoracoscope was inserted near the anterior axillary line of the third intercostal space into the chest with CO2 input. A pericardial longitudinal incision was made under direct vision, extending to the head side and reflexed when reaching the aorta, with the pericardium suspended. Extracorporeal circulation was started, and Chitwood occlusion forceps were inserted into the chest to block the ascending aorta through the fourth intercostal space; the drainage tube of the left atrium perforated the chest through the right midaxillary line between the fifth and sixth intercostal space. 4-0 Prolene was used for the purse-string suturing of the cardioplegia cannula and antegradecardioplegia fluid was performed. After electrocardiograph monitoring showed that electrocardiac activity had stopped, the interatrial groove was freed, the left atrial incision was made parallel to the interatrial groove, and the left atrial drainage tube was inserted. A left atrial retractor was placed and stretched to the surface for fixation through the perforation into the prothorax, and the left atrial incision was retracted in the direction of the sternum. Removal of the damaged mitral valve by endoscopic surgical instruments, and the mitral valve was sutured intermittently. After examination of the valve location and the opening and closing performance of the valve leaf, the left atrial incision was sutured continuously by prolene 4/0. Retrograde cardioplegia perfusion through the tube was initiated for venting and rewarming of the patient started, and the anesthesiologist ventilated the lungs with air to keep the lung lobes full and to relieve the occlusion of the ascending aorta. Cardiopulmonary bypass was stopped gradually and bleeding was stopped; a chest drainage tube was inserted through the hole for the left atrium drainage tube, and the chest was closed.
- Conditions
- Rheumatic Mitral Valve Disease
- Being tested
- minimally invasive rheumatic mitral valve surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive rheumatic mitral valve surgeryProcedure or surgery
First, venous and arterial access was established. Incision establishment: A 4 to 6 cm incision was opened in the chest anterolaterally to the right of the fourth intercostal space (in submamarry vs. peri areolar approach ). The thoracoscope was inserted. Bypass started, and Chitwood occlusion forceps were inserted to block the ascending aorta, purse-string suturing of the cardioplegia cannula and antegradecardioplegia fluid was performed, the interatrial groove was freed, the left atrial incision was made. Removal of the damaged mitral valve mostly by endoscopic surgical instruments (not usually there is a chance for repair), and the mitral valve was sutured intermittently. After examination of the valve location and the opening and closing performance of the valve leaf, the left atrial incision was sutured continuously by prolene 4/0. Weaning from bypass start
| Study group | Role | What they receive |
|---|---|---|
| group A | periareolar approach Receives: Procedure: minimally invasive rheumatic mitral valve surgery | |
| group B | submamary approach Receives: Procedure: minimally invasive rheumatic mitral valve surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
identify of advantages and disadvantages of each approach
discussing and finding each approachs advantages and disadvantages and comparing with each other
Measured: 1/1/2022 TO 1/1/2025
Assess the outcome regarding: -Wound size
measuring Wound size (in cm ) of each approach
Measured: 1/1/2022 TO 1/1/2025
Assess the outcome regarding: -Postoperative pain and patient satisfaction
measuring postoperative pain and patient satisfaction by pain scale of each approach
Measured: 1/1/2022 TO 1/1/2025
assess Wound complication
assess Wound complication (as infection (superfacial , deep , burst chest )
Measured: 1/1/2022 TO 1/1/2025
Secondary outcomes (2)
Assess the outcome regarding: Economic factor
Assess the outcome regarding:
-Economic factor ( ICU stay or hospital stay)
Measured: 1/1/2022 TO 1/1/2025
Assess the outcome regarding:Time of procedure
Assess the outcome regarding:Time of procedure ( time of total bypass time , time for rapid access, time of haemostasis)
Measured: 1/1/2022 TO 1/1/2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Mar 2022 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rheumatic Mitral Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Rabee Hamed Ahmed, Assiut University
- Investigators
- Anwar A Atia, MD in cardiothoracic surgery, Study chair, Professor of cardiothoracic surgeryAhmed N Malik, MD in cardiothoracic surgery, Study chair, Professor of cardiothoracic surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270590
- Sponsor's protocol ID
- peri areolar MVR
- Status last verified
- Feb 2022
- First submitted
- 15 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Watkins DA, Johnson CO, Colquhoun SM, Karthikeyan G, Beaton A, Bukhman G, Forouzanfar MH, Longenecker CT, Mayosi BM, Mensah GA, Nascimento BR, Ribeiro ALP, Sable CA, Steer AC, Naghavi M, Mokdad AH, Murray CJL, Vos T, Carapetis JR, Roth GA. Global, Regional, and National Burden of Rheumatic Heart Disease, 1990-2015. N Engl J Med. 2017 Aug 24;377(8):713-722. doi: 10.1056/NEJMoa1603693.
PubMed 28834488Antunes MJ. Minimally invasive valve surgery: reality, dream or utopia? J Heart Valve Dis. 1998 Jul;7(4):358-9. No abstract available.
PubMed 9697053Takeda M, Konishi T, Fukata M, Matsuzaki K, Furuya K. [Minimally invasive surgery for single valvular heart disease]. J Cardiol. 1999 Oct;34(4):219-23. Japanese.
PubMed 10553539Modi P, Hassan A, Chitwood WR Jr. Minimally invasive mitral valve surgery: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2008 Nov;34(5):943-52. doi: 10.1016/j.ejcts.2008.07.057. Epub 2008 Sep 30.
PubMed 18829343
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Outcome of Minimally Invasive Rheumatic Mitral Valve Surgery Through Periareolar Versus Submamary Approach
- ClinicalTrials.gov ID
- NCT05270590
- Acronym / sponsor ID
- peri areolar MVR
- Conditions
- Rheumatic Mitral Valve Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 8 Mar 2022 (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.
Early outcome of minimally invasive rheumatic mitral valve surgery through periareolar versus submamary approach
Detailed description
Rheumatic heart valve disease (RHVD) is a post-infectious sequel of acute rheumatic fever resulting from an abnormal immune response to a streptococcal pharyngitis that triggers valvular damage. RHVD is the leading cause of cardiovascular death in children and young adults, mainly in women from low and middle-income countries. It is known that long-term inflammation and high degree of fibrosis leads to valve dysfunction due to anatomic disruption of the valve apparatus.in low and middle-income countries, rheumatic heart valve disease (RHVD) is the leading cause of cardiovascular death in children and young adults When there is severe valvular dysfunction, especially if the patient is symptomatic, surgery is indicated. (1)Traditional mitral valve surgery via a median sternotomy is safe and effective, but it results in a high degree of trauma and a long incision.(2) In the last 2 decades, a minimally invasive (MI) technique has been used widely in cardiac surgery.(3-4) Its prominent advantage in post-surgery recovery and the small incision required makes patients prefer it over a traditional incision.(5-6) Patients underwent Minimal invasive surgery after intravenous anaesthesia combined with general anaesthesia, and their right side was elevated at 30°. After disinfection and draping were performed with sterile protective film fixed to it. Establishing the in vitro pathway: First, venous and arterial access was established. Incision establishment: A 4 to 6 cm incision was opened layer by layer in the chest anterolaterally to the right of the fourth intercostal space (in submamarry vs. peri areolar approach ). A lap-protector was placed. The thoracoscope was inserted near the anterior axillary line of the third intercostal space into the chest with CO2 input. A pericardial longitudinal incision was made under direct vision, extending to the head side and reflexed when reaching the aorta, with the pericardium suspended. Extracorporeal circulation was started, and Chitwood occlusion forceps were inserted into the chest to block the ascending aorta through the fourth intercostal space; the drainage tube of the left atrium perforated the chest through the right midaxillary line between the fifth and sixth intercostal space. 4-0 Prolene was used for the purse-string suturing of the cardioplegia cannula and antegradecardioplegia fluid was performed. After electrocardiograph monitoring showed that electrocardiac activity had stopped, the interatrial groove was freed, the left atrial incision was made parallel to the interatrial groove, and the left atrial drainage tube was inserted. A left atrial retractor was placed and stretched to the surface for fixation through the perforation into the prothorax, and the left atrial incision was retracted in the direction of the sternum. Removal of the damaged mitral valve by endoscopic surgical instruments, and the mitral valve was sutured intermittently. After examination of the valve location and the opening and closing performance of the valve leaf, the left atrial incision was sutured continuously by prolene 4/0. Retrograde cardioplegia perfusion through the tube was initiated for venting and rewarming of the patient started, and the anesthesiologist ventilated the lungs with air to keep the lung lobes full and to relieve the occlusion of the ascending aorta. Cardiopulmonary bypass was stopped gradually and bleeding was stopped; a chest drainage tube was inserted through the hole for the left atrium drainage tube, and the chest was closed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | Procedure: minimally invasive rheumatic mitral valve surgeryperiareolar approach |
| group B | – | Procedure: minimally invasive rheumatic mitral valve surgerysubmamary approach |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patient undergoing minimal invasive rheumatic mitral valve surgery
Key inclusion criteria (4 listed)
- Clinical diagnosis of rheumatic mitral valve
- Patient undergoing minimal invasive rheumatic mitral valve surgery
- Patient is willing to comply with all follow-up visits.
- Willing and able to provide written informed consent and comply with study requirements
Key exclusion criteria (3 listed)
- Ischemic heart disease
- Patients need another valve replacement
- Redo mitral valve replacement
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 |
|---|---|---|
| minimally invasive rheumatic mitral valve surgeryFirst, venous and arterial access was established. Incision establishment: A 4 to 6 cm incision was opened in the chest anterolaterally to the right of the fourth intercostal space (in submamarry vs. peri areolar approach ). The thoracoscope was inserted. Bypass started, and Chitwood occlusion forceps were inserted to block the ascending aorta, purse-string suturing of the cardioplegia cannula and antegradecardioplegia fluid was performed, the interatrial groove was freed, the left atrial incision was made. Removal of the damaged mitral valve mostly by endoscopic surgical instruments (not usually there is a chance for repair), and the mitral valve was sutured intermittently. After examination of the valve location and the opening and closing performance of the valve leaf, the left atrial incision was sutured continuously by prolene 4/0. Weaning from bypass start | Procedure or surgery | group A, group B |
Primary outcome
identify of advantages and disadvantages of each approach
Time frame: 1/1/2022 TO 1/1/2025
discussing and finding each approachs advantages and disadvantages and comparing with each other
Assess the outcome regarding: -Wound size
Time frame: 1/1/2022 TO 1/1/2025
measuring Wound size (in cm ) of each approach
Assess the outcome regarding: -Postoperative pain and patient satisfaction
Time frame: 1/1/2022 TO 1/1/2025
measuring postoperative pain and patient satisfaction by pain scale of each approach
assess Wound complication
Time frame: 1/1/2022 TO 1/1/2025
assess Wound complication (as infection (superfacial , deep , burst chest )
2 secondary outcomes
Assess the outcome regarding: Economic factor
Time frame: 1/1/2022 TO 1/1/2025
Assess the outcome regarding:Time of procedure
Time frame: 1/1/2022 TO 1/1/2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Background: PubMed 28834488Watkins DA, Johnson CO, Colquhoun SM, Karthikeyan G, Beaton A, Bukhman G, Forouzanfar MH, Longenecker CT, Mayosi BM, Mensah GA, Nascimento BR, Ribeiro ALP, Sable CA, Steer AC, Naghavi M, Mokdad AH, Murray CJL, Vos T, Carapetis JR, Roth GA. Global, Regional, and National Burden of Rheumatic Heart Disease, 1990-2015. N Engl J Med. 2017 Aug 24;377(8):713-722. doi: 10.1056/NEJMoa1603693.
- Background: PubMed 9697053Antunes MJ. Minimally invasive valve surgery: reality, dream or utopia? J Heart Valve Dis. 1998 Jul;7(4):358-9. No abstract available.
- Background: PubMed 10553539Takeda M, Konishi T, Fukata M, Matsuzaki K, Furuya K. [Minimally invasive surgery for single valvular heart disease]. J Cardiol. 1999 Oct;34(4):219-23. Japanese.
- Background: PubMed 18829343Modi P, Hassan A, Chitwood WR Jr. Minimally invasive mitral valve surgery: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2008 Nov;34(5):943-52. doi: 10.1016/j.ejcts.2008.07.057. Epub 2008 Sep 30.
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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.
Anwar A Atia, MD in cardiothoracic surgery study chair
Professor of cardiothoracic surgery
Ahmed N Malik, MD in cardiothoracic surgery study chair
Professor of cardiothoracic surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Mitral Valve Disease, run by Assiut University.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohammed R hamed, becholar in general surgery (01024631721, x_spiders123@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identify of advantages and disadvantages of each approach (time frame: 1/1/2022 TO 1/1/2025). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05270590, which also lists 4 linked publications.
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 8 Mar 2022.