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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Coronary Bypass Graft Stenosis, Valvular Heart Disease

Intervention / Treatment
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* Procedure: robot-assisted surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| bypass graft, sternotomy<br>patients who have received coronary artery bypass graft surgery with conventional sternotomy procedure | |
| bypass graft, robot<br>patients who have received coronary artery bypass graft surgery with robot-assisted procedure | Procedure: robot-assisted surgery<br>* traditional sternotomy for coronary bypass graft or valvular replacement robot-assisted surgery for coronary bypass graft or valvular replacement<br>* Other names: sternotomy;|
| valvular heart disease, sternotomy<br>patients who have received valvular replacement surgery with conventional sternotomy procedure | |
| valvular heart disease, robot<br>patients who have received valvular replacement surgery with robot-assisted procedure | Procedure: robot-assisted surgery<br>* traditional sternotomy for coronary bypass graft or valvular replacement robot-assisted surgery for coronary bypass graft or valvular replacement<br>* Other names: sternotomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of maximal oxygen consumption post-surgery | the change of maximal oxygen consumption from surgery before to 2 weeks after surgery | pre-operation to 2 weeks post-operation | 
| Change of maximal oxygen consumption in 3 months | the change of maximal oxygen consumption from before surgery to 3 months after surgery | pre-operation to 3 months post-operation | 
| Change of anaerobic threshold post surgery | the change of the onset of lactate accumulation in blood from before surgery to 2 weeks after surgery | pre-operation to 2 weeks post-operation | 
| 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 | pre-operation to 3 months post-operation | 
| Change of six minute walking test result post-surgery | the change of six minute walking test result from before surgery to 2 weeks after surgery | pre-operation to 2 weeks post-operation | 
| Change of six minute walking test result in 3 months | the change of six minute walking test result from before surgery to 3 months after surgery | pre-operation to 3 months post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of vital capacity post-surgery | the change of vital capacity during pulmonary function testing from before surgery to 2 weeks after surgery | pre-operation to 2 weeks post-operation | 
| Change of vital capacity in 3 months | the change of vital capacity during pulmonary function testing from before surgery to 3 months after surgery | pre-operation to 3 months post-operation | 
| 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 | pre-operation to 2 weeks post-operation | 
| 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 | pre-operation to 3 months post-operation | 
| Change of resting heart rate post-surgery | the change of resting heart rate from before surgery to 2 weeks after surgery | pre-operation to 2 weeks post-operation | 
| Change of resting heart rate in 3 months | the change of resting heart rate from before surgery to 3 months after surgery | pre-operation to 3 months post-operation | 
| Change of oxygen pulse post-surgery | the change of the maximal value of VO2 divided by heart rate during exercise testing from before surgery to 2 weeks after surgery | pre-operation to 2 weeks post-operation | 
| Change of oxygen pulse in 3 months | the change of the maximal value of VO2 divided by heart rate during exercise testing from before surgery to 3 months after surgery | pre-operation to 3 months post-operation | 
| pain post-surgery | pain visual analog scale score (from 0 to 10, higher score means more painful) for surgery wound pain at 2 weeks after surgery | 2 weeks post-operation | 
| pain in 3 months | pain visual analog scale score (from 0 to 10, higher score means more painful) for surgery wound pain at 3 months after surgery | 3 months post-operation | 
| Change of activity status post-surgery | the change of the Duke Activity Status Index (DASI) score from before surgery to 2 weeks after surgery. The DASI is a score ranging from 0 to 58.2. A higher score indicates a better cardiorespiratory fitness. | pre-operation to 2 weeks post-operation | 
| Change of activity status in 3 months | the change of the Duke Activity Status Index (DASI) score from before surgery to 3 months after surgery The DASI is a score ranging from 0 to 58.2. A higher score indicates a better cardiorespiratory fitness. | pre-operation to 3 months post-operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiorespiratory fitness, robotic assisted surgery, cardiopulmonary exercise testing