Comparison of Early Postoperative Outcomes Between Minimally Invasive Valve Surgery Via Right Thoracotomy and Conventional Valve Surgery Via Sternotomy.
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Minimally Invasive Valve Surgery, Conventional Valve Surgery.
- Who it may be relevant to
- Registry conditions: Heart Valve Diseases or Prosthesis, Aortic Valve Stenosis, Aortic Valve Insufficiency, Valvular Heart Disease Stenosis and Regurgitation (Diagnosis). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Early Postoperative Outcomes Between Minimally Invasive Valve Surgery Via Right Thoracotomy and Conventional Valve Surgery Via Sternotomy
Overview
This randomized controlled trial aims to compare early postoperative outcomes between Minimally Invasive Valve Surgery (MIVS) via right thoracotomy and Conventional Valve Surgery via median sternotomy in patients undergoing elective, isolated mitral or aortic valve surgery. Minimally invasive techniques are believed to reduce postoperative pain, ventilation time, chest drain output, and wound complications, but evidence from Pakistan is limited. The study will enroll patients of all ages and genders who are scheduled for isolated valvular procedures at Chaudhary Pervaiz Elahi Institute of Cardiology (CPEIC), Multan. Participants will be randomly assigned to undergo either minimally invasive thoracotomy or conventional sternotomy. Primary outcomes include ventilation time, CPB duration, cross-clamp time, pain scores, and chest drain output. Secondary outcomes include wound healing (Day 7 and 30 days), return to routine activity, echocardiographic evaluation, transfusion requirements, and 30-day mortality. Findings from this study may provide evidence to guide the adoption of minimally invasive valvular surgery techniques in low-resource and developing settings.
Detailed description
Valvular heart disease is a significant contributor to cardiovascular morbidity worldwide and often requires surgical intervention. Although median sternotomy provides excellent exposure for valve repair and replacement, it is associated with increased surgical trauma, prolonged recovery time, higher postoperative pain, and cosmetically visible scarring.
Minimally Invasive Valve Surgery (MIVS) through a right thoracotomy has emerged as a promising alternative approach, offering advantages such as smaller incisions, reduced postoperative discomfort, shorter hospitalization, and improved cosmetic outcomes-without compromising procedural safety. International evidence demonstrates comparable mortality and valve repair quality between the two techniques, with additional benefits favoring minimally invasive approaches such as reduced transfusion needs and fewer sternal wound complications. However, data from Pakistan remain sparse.
This randomized controlled trial is designed to evaluate the early postoperative outcomes of MIVS versus conventional sternotomy in a tertiary cardiac surgery center in Pakistan. Eligible patients undergoing elective, isolated mitral or aortic valve surgery will be randomized using a computer-generated sequence to one of two groups:
Group A (MIVS): Right anterolateral thoracotomy with femoral cannulation and transthoracic aortic clamping.
Group B (Sternotomy): Median sternotomy with standard central cannulation.
Both groups will receive standardized anesthesia, cardiopulmonary bypass protocols, myocardial protection strategies, and postoperative ICU care. The surgical procedures will be performed by experienced cardiac surgeons, and all perioperative variables will be recorded using a structured proforma.
Primary Outcomes
Cardiopulmonary bypass (CPB) time
Aortic cross-clamp time
Duration of mechanical ventilation
Postoperative pain score (NRS at 12 and 24 hours)
Total chest drain output in the first 24 hours
Secondary Outcomes
PRBC transfusion requirement
Wound condition on postoperative day 7
Echocardiographic findings before discharge and at 30 days
Return to routine daily activity by 30 days
30-day all-cause mortality
Patients will be followed for 30 days after surgery. Data will be analyzed using IBM SPSS v25. Continuous variables will be compared using an independent samples t-test, while categorical variables will be assessed via the Chi-square test. A p-value of \<0.05 will be considered statistically significant.
This study aims to provide local evidence comparing the two surgical approaches and help determine whether minimally invasive valve surgery should be more widely adopted as a preferred option in tertiary cardiac surgical practice.
Interventions
- Procedure Minimally Invasive Valve Surgery
Participants in this group will undergo minimally invasive valve surgery through a right anterolateral thoracotomy. A small 5-7 cm incision will be made in the 4th or 5th intercostal space. Cardiopulmonary bypass will be established using femoral arterial and venous cannulation. A transthoracic aortic cross-clamp will be applied, and cold blood cardioplegia will be administered. The mitral or aortic valve will be accessed through limited thoracic exposure and repaired or replaced using standard - Procedure Conventional Valve Surgery
Participants in this group will undergo conventional open-heart valve surgery through a full median sternotomy. Cardiopulmonary bypass will be established using aortic and right atrial cannulation. Standard antegrade cold blood cardioplegia will be administered for myocardial protection. The mitral or aortic valve will be exposed through full sternal access and repaired or replaced following established institutional protocols. This approach represents the traditional surgical method used for va
Primary outcome measures
- Duration of Mechanical Ventilation [Time frame: 24 hours]
Secondary outcome measures (8)
- Cardiopulmonary Bypass Time [Time frame: During surgery]
- Aortic Cross-Clamp Time [Time frame: During surgery]
- Chest Drain Output [Time frame: First 24 hours postoperatively]
- Postoperative Pain Score (NRS) [Time frame: 12 hours and 24 hours after surgery]
- SSI on Postoperative Day 7 [Time frame: Postoperative day 7]
- SSI at 30-Day Follow-Up [Time frame: 30 days postoperatively]
- Packed Red Blood Cell Transfusion Requirement [Time frame: First 24 hours postoperatively]
- 30-Day All-Cause Mortality [Time frame: Within 30 days postoperative]
Eligibility criteria
Inclusion criteria
- Patients of any age and gender.
- Undergoing elective, isolated mitral or aortic valve surgery.
- Considered suitable for either:
- MIVS via right thoracotomy, or
- Conventional valve surgery , as decided by the operating surgical team.
- Patients giving written informed consent.
Exclusion criteria
- Emergency or redo cardiac surgeries
- Concomitant cardiac procedures (e.g., CABG, multiple valve replacements)
- Ejection Fraction <30%
- Severe pulmonary hypertension (identified as the mean pulmonary artery pressure (mPAP) exceeding 45 mmHg on echocardiography, as outlined by the AHA guidelines(10).
- Active systemic infections or sepsis at the time of surgery
- Refusal to participate in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07251660 · CPEIC -321