Clinical trial NCT05430568: Comparison of Post-operation Cardiopulmonary Capacity of Patients Underwent Conventional and Robot-assisted Coronary Artery Bypass Graft and Valve Replacement Surgery
Official title: Comparison of Post-operation Cardiopulmonary Capacity of Patients Underwent Conventional and Robot-assisted Coronary Artery Bypass Graft and Valve Replacement Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Bypass Graft Stenosis
Valvular Heart Disease
Keywords: cardiorespiratory fitness
robotic assisted surgery
cardiopulmonary exercise testing
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: coronary artery and valvular heart disease patients

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Change of maximal oxygen consumption post-surgery
timeFrame: pre-operation to 2 weeks post-operation
measure: Change of maximal oxygen consumption in 3 months
timeFrame: pre-operation to 3 months post-operation
measure: Change of anaerobic threshold post surgery
timeFrame: pre-operation to 2 weeks post-operation
measure: Change of anaerobic threshold in 3 months
timeFrame: pre-operation to 3 months post-operation
measure: Change of six minute walking test result post-surgery
timeFrame: pre-operation to 2 weeks post-operation
measure: Change of six minute walking test result in 3 months
timeFrame: pre-operation to 3 months post-operation
Secondary outcomes:
measure: Change of vital capacity post-surgery
timeFrame: pre-operation to 2 weeks post-operation
measure: Change of vital capacity in 3 months
timeFrame: pre-operation to 3 months post-operation
measure: Change of respiratory flow post-surgery
timeFrame: pre-operation to 2 weeks post-operation
measure: Change of respiratory flow ratio in 3 months
timeFrame: pre-operation to 3 months post-operation
measure: Change of resting heart rate post-surgery
timeFrame: pre-operation to 2 weeks post-operation
measure: Change of resting heart rate in 3 months
timeFrame: pre-operation to 3 months post-operation
measure: Change of oxygen pulse post-surgery
timeFrame: pre-operation to 2 weeks post-operation
measure: Change of oxygen pulse in 3 months
timeFrame: pre-operation to 3 months post-operation
measure: pain post-surgery
timeFrame: 2 weeks post-operation
measure: pain in 3 months
timeFrame: 3 months post-operation
measure: Change of activity status post-surgery
timeFrame: pre-operation to 2 weeks post-operation
measure: Change of activity status in 3 months
timeFrame: pre-operation to 3 months post-operation
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Taichung Veterans General Hospital
name: Yuchun Lee, MD
role: STUDY_DIRECTOR
References: