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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorTaichung Veterans General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

coronary artery and valvular heart disease patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • robot-assisted surgery

    Procedure/Surgery

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

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: bypass graft, sternotomy0 interventions
Group B: bypass graft, robot1 intervention
Group C: valvular heart disease, sternotomy0 interventions
Group D: valvular heart disease, robot1 intervention

Trial outcomes

Primary outcomes

1

Change of maximal oxygen consumption post-surgery

the change of maximal oxygen consumption from surgery before to 2 weeks after surgery

Time frame
pre-operation to 2 weeks post-operation
2

Change of maximal oxygen consumption in 3 months

the change of maximal oxygen consumption from before surgery to 3 months after surgery

Time frame
pre-operation to 3 months post-operation
3

Change of anaerobic threshold post surgery

the change of the onset of lactate accumulation in blood from before surgery to 2 weeks after surgery

Time frame
pre-operation to 2 weeks post-operation
4

Change of anaerobic threshold in 3 months

the change of the onset of lactate accumulation in blood from before surgery to 3 months after surgery

Time frame
pre-operation to 3 months post-operation

Secondary outcomes

1

Change of vital capacity post-surgery

the change of vital capacity during pulmonary function testing from before surgery to 2 weeks after surgery

Time frame
pre-operation to 2 weeks post-operation
2

Change of vital capacity in 3 months

the change of vital capacity during pulmonary function testing from before surgery to 3 months after surgery

Time frame
pre-operation to 3 months post-operation
3

Change of respiratory flow post-surgery

the change of the ratio of air volume on exhalation to vital capacity during the first second in the pulmonary function testing from before surgery to 2 weeks after surgery

Time frame
pre-operation to 2 weeks post-operation
4

Change of respiratory flow ratio in 3 months

the change of the ratio of air volume on exhalation to vital capacity during the first second in the pulmonary function testing from before surgery to 3 months after surgery

Time frame
pre-operation to 3 months post-operation

Other outcomes

Sponsors and contacts

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