NCT05430568

Comparison of Post-operation Cardiopulmonary Capacity of Patients Underwent Conventional and Robot-assisted Coronary Artery Bypass Graft and Valve Replacement Surgery

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Taichung Veterans General Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Robotic surgery is one of the most popular minimally invasive procedures for patients with coronary artery disease or valvular diseases. Studies have shown that, as compared to conventional sternotomy, patients underwent robot-assisted bypass grafting or valvuloplasty had less post-operation pain, blood transfusion volume during operation, re-operation rate, post-operation stroke rate and length of hospitalization. However, most studies focused on the comparison of complications of different procedures, and the investigation of cardiopulmonary function recovery is still lacking. Thus our study is to compare the functional outcomes between patients that undergo different surgical procedures.

Detailed description

The study is a prospective cohort study. The experimental group will include 40 patients, consisting 20 after robotic coronary artery bypass grafting and 20 after robotic valvuloplasty. The control group will include 20 patients for each conventional procedure. Once decided the surgery type, the surgeon will consult the rehabilitation department and the director of this trial for inform consent. The recruitment and allocation will only be done after the patient has decided which type of surgery to receive. However, in case of change of surgery type, the patient will be excluded from the trial. Cardiopulmonary exercise testing, 6-minute walking test and questionnaires about wound pain and cardiac functional status will be performed before surgery, two weeks after discharge and three months after discharge respectively. Primary outcomes include the change of maximal oxygen consumption (VO2), anaerobic threshold and the result of six minute walking test before and after surgery. Secondary outcomes include the change vital capacity (FVC), resting heart rate, oxygen pulse (O2 pulse), wound pain visual analog scale (VAS) and Duke Activity Status Index (DASI) before and after surgery. The hypothesis of this study is that patients who undergo robot-assisted surgery will have better cardiopulmonary outcomes than those receive conventional surgery

Conditions

• Coronary Bypass Graft Stenosis
• Valvular Heart Disease

Interventions

Type	Name	Description
PROCEDURE	robot-assisted surgery	1. traditional sternotomy for coronary bypass graft or valvular replacement 2. robot-assisted surgery for coronary bypass graft or valvular replacement

Timeline

• Start date: 2025-11-01
• Primary completion: 2027-06-30
• Completion: 2028-05-31
• First posted: 2022-06-24
• Last updated: 2025-09-09

Locations

1 site across 1 country: Taiwan