Comparison of Early Postoperative Outcomes Between Minimally Invasive Valve Surgery Via Right Thoracotomy and Conventional Valve Surgery Via Sternotomy.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChaudhry Pervaiz Elahi Institute of Cardiology

About this trial

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.

Eligibility criteria

Qualifiers

Patients of any age and gender.

Undergoing elective, isolated mitral or aortic valve surgery.

MIVS via right thoracotomy, or

Conventional valve surgery , as decided by the operating surgical team.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Minimally Invasive Valve Surgery
  • Conventional Valve Surgery

Treatment groups

32 Participants
are divided into 2 treatment groups

Locations

This trial has no locations