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

Taichung Veterans General Hospital

Status: Not yet enrolling

Conditions: Coronary Bypass Graft Stenosis; Valvular Heart Disease

Treatments: Procedure: robot-assisted surgery

Study type: Observational

Funder types: Other

Identifiers

NCT05430568

CE22214A

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient who undergo surgery for coronary artery bypass graft or valvular replacement.

Exclusion criteria

• pregnant
• patients who receive more than one type of surgery
• severe complications after surgery (ex. respiratory failure, stroke) and stayed in hospital for more than 2 weeks.
• cannot perform the cardiopulmonary exercise testing
• other contraindications for cardiopulmonary exercise testing

Trial design

80 participants in 4 patient groups

bypass graft, sternotomy

Description:

patients who have received coronary artery bypass graft surgery with conventional sternotomy procedure

bypass graft, robot

Description:

patients who have received coronary artery bypass graft surgery with robot-assisted procedure

Treatment:

Procedure: robot-assisted surgery

valvular heart disease, sternotomy

Description:

patients who have received valvular replacement surgery with conventional sternotomy procedure

valvular heart disease, robot

Description:

patients who have received valvular replacement surgery with robot-assisted procedure

Treatment:

Procedure: robot-assisted surgery