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

NCT07251660 | Not Yet Recruiting

• 1 other identifier: CPEIC -321
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Heart valve disease; Mitral valve surgery Aortic valve surgery Minimally invasive cardiac surgery; Conventional open-heart surgery; Aortic cross-clamping; Early postoperative outcomes

Outcome Measures

Primary Outcomes (1)

• Duration of Mechanical Ventilation

  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.

  24 hours

Secondary Outcomes (8)

• 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

Study Arms (2)

Minimally invasive valve surgery via right thoracotomy

EXPERIMENTAL

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.

Procedure: Minimally Invasive Valve Surgery

Conventional Valve Surgery via Median Sternotomy

ACTIVE COMPARATOR

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.

Procedure: Conventional Valve Surgery

Interventions

Minimally Invasive Valve Surgery 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.

Minimally invasive valve surgery via right thoracotomy

Conventional Valve Surgery 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.

Conventional Valve Surgery via Median Sternotomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chaudhry Pervaiz Elahi Institute of Cardiology: lead

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Valve Stenosis; Aortic Valve Insufficiency; Gastroesophageal Reflux; Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mujtaba A Siddiqui

  Chaudhary Pervaiz Elahi Institute of cardiology Multan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Bilal Hassan Resident Cardiac Surgery, MBBS

CONTACT

+3006157734; garhamore88@gmail.com

Muhammad Hamid Senior Registrar, MBBS

CONTACT

dr.hamid632@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 26, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: De-identified IPD and supporting study documentation will be available six months after publication of the main study results and will remain accessible for up to three years thereafter. Access beyond this time frame may be granted upon reasonable request and approval by the primary investigator and the institutional review board.
• Access Criteria: Access to de-identified IPD will be granted to qualified researchers affiliated with academic, clinical, or scientific institutions for purposes of meta-analysis, systematic review, or secondary methodological evaluation. Requests must include a brief research proposal and data use agreement. Approved researchers will receive data through a secure, password-protected institutional repository or encrypted email transfer. No commercial use will be permitted.