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Rheumatic Mitral Valve DiseaseNCT05270590

Minimally Invasive Rheumatic Mitral Valve Surgery

An observational study of Rheumatic Mitral Valve Disease, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

mohammed R hamed, becholar in general surgery contact

01024631721

x_spiders123@yahoo.com

Ahmed Elminshawy, MD in cardiothoracic surgery contact

01112743943

aelminshawy@aun.edu.eg

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.

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 groups in NCT05270590
Study groupRoleWhat they receive
group Aperiareolar approach
Receives: Procedure: minimally invasive rheumatic mitral valve surgery
group Bsubmamary 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.

  1. 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

  2. Assess the outcome regarding: -Wound size

    measuring Wound size (in cm ) of each approach

    Measured: 1/1/2022 TO 1/1/2025

  3. 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

  4. assess Wound complication

    assess Wound complication (as infection (superfacial , deep , burst chest )

    Measured: 1/1/2022 TO 1/1/2025

Secondary outcomes (2)
  1. 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

  2. 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.

  1. First posted8 Mar 2022
  2. Study start1 Mar 2022 (estimated)
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 Jan 2026 (estimated)

Resources

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)
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 28834488
  • Antunes MJ. Minimally invasive valve surgery: reality, dream or utopia? J Heart Valve Dis. 1998 Jul;7(4):358-9. No abstract available.

    PubMed 9697053
  • Takeda 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 10553539
  • Modi 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

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.

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