Clinical Trial

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

Not Yet Recruiting
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Record status
This record was last updated November 26, 2025 (before its estimated July 15, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT07251660
Lead Sponsor Chaudhry Pervaiz Elahi Institute of Cardiology
Conditions Heart Valve Diseases or Prosthesis, Aortic Valve Stenosis, Aortic Valve Insufficiency, Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)
Enrollment 32 participants
Start Date 2025-12-15
Primary Completion 2026-07-15 (estimated)
Study Completion 2026-08-15 (estimated)
Updated on ClinicalTrials.gov 2025-11-26