Comparison of Early Postoperative Outcomes Between Minimally Invasive Valve Surgery Via Right Thoracotomy and Conventional Valve Surgery Via Sternotomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 主要终点
- Duration of Mechanical Ventilation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Duration of Mechanical Ventilation
时间窗: 24 hours
The duration of postoperative mechanical ventilation will be measured in hours from the time the patient arrives in the intensive care unit (ICU) after surgery until successful extubation. This outcome evaluates early recovery, respiratory function, and perioperative morbidity following minimally invasive valve surgery versus conventional sternotomy.
次要结局
- Cardiopulmonary Bypass Time(During surgery)
- Aortic Cross-Clamp Time(During surgery)
- Chest Drain Output(First 24 hours postoperatively)
- Postoperative Pain Score (NRS)(12 hours and 24 hours after surgery)
- SSI on Postoperative Day 7(Postoperative day 7)
- SSI at 30-Day Follow-Up(30 days postoperatively)
- Packed Red Blood Cell Transfusion Requirement(First 24 hours postoperatively)
- 30-Day All-Cause Mortality(Within 30 days postoperative)