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

NCT ID: NCT07251660

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2026-08-15

Brief 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.

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.

Conditions

Heart Valve Diseases or Prosthesis; Aortic Valve Stenosis; Aortic Valve Insufficiency; Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Minimally invasive valve surgery via right thoracotomy

Participants in this arm will undergo minimally invasive valve surgery through a right anterolateral thoracotomy. Cardiopulmonary bypass will be established via femoral arterial and venous cannulation. A transthoracic aortic cross-clamp will be used, and the mitral or aortic valve will be repaired or replaced using standard minimally invasive techniques. This approach uses a smaller incision, avoids median sternotomy, and aims to reduce postoperative pain, ventilation time, and wound complications.

Group Type: EXPERIMENTAL

Minimally Invasive Valve Surgery

Intervention Type: PROCEDURE

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 techniques. This approach avoids median sternotomy and aims to reduce postoperative pain, ventilation time, transfusion needs, and wound complications.

Conventional Valve Surgery via Median Sternotomy

Participants in this arm will undergo conventional open-heart valve surgery through a full median sternotomy. Cardiopulmonary bypass will be established with aortic and right atrial cannulation. Cold-blood cardioplegia will be administered antegrade, and the diseased valve will be accessed and either replaced or repaired via standard surgical exposure. This approach represents the established conventional method used for valvular surgery.

Group Type: ACTIVE_COMPARATOR

Conventional Valve Surgery

Intervention Type: PROCEDURE

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 valvular heart disease.

Interventions

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 techniques. This approach avoids median sternotomy and aims to reduce postoperative pain, ventilation time, transfusion needs, and wound complications.

Intervention Type: 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 valvular heart disease.

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chaudhry Pervaiz Elahi Institute of Cardiology

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mujtaba A Siddiqui

Role: PRINCIPAL_INVESTIGATOR

Chaudhary Pervaiz Elahi Institute of cardiology Multan

Central Contacts

Dr Bilal Hassan Resident Cardiac Surgery, MBBS

Role: CONTACT

garhamore88@gmail.com

+3006157734

Muhammad Hamid Senior Registrar, MBBS

Role: CONTACT

dr.hamid632@gmail.com

Other Identifiers

CPEIC -321

Identifier Type: -

Identifier Source: org_study_id