Comparison of Post-operation Cardiopulmonary Capacity of Patients Underwent Conventional and Robot-assisted Coronary Artery Bypass Graft and Valve Replacement Surgery
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: robot-assisted surgery.
- Who it may be relevant to
- Registry conditions: Coronary Bypass Graft Stenosis, Valvular Heart Disease. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- 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
Primary outcome measures
- Change of maximal oxygen consumption post-surgery [Time frame: pre-operation to 2 weeks post-operation]
- Change of maximal oxygen consumption in 3 months [Time frame: pre-operation to 3 months post-operation]
- Change of anaerobic threshold post surgery [Time frame: pre-operation to 2 weeks post-operation]
- Change of anaerobic threshold in 3 months [Time frame: pre-operation to 3 months post-operation]
- Change of six minute walking test result post-surgery [Time frame: pre-operation to 2 weeks post-operation]
- Change of six minute walking test result in 3 months [Time frame: pre-operation to 3 months post-operation]
Secondary outcome measures (12)
- Change of vital capacity post-surgery [Time frame: pre-operation to 2 weeks post-operation]
- Change of vital capacity in 3 months [Time frame: pre-operation to 3 months post-operation]
- Change of respiratory flow post-surgery [Time frame: pre-operation to 2 weeks post-operation]
- Change of respiratory flow ratio in 3 months [Time frame: pre-operation to 3 months post-operation]
- Change of resting heart rate post-surgery [Time frame: pre-operation to 2 weeks post-operation]
- Change of resting heart rate in 3 months [Time frame: pre-operation to 3 months post-operation]
- Change of oxygen pulse post-surgery [Time frame: pre-operation to 2 weeks post-operation]
- Change of oxygen pulse in 3 months [Time frame: pre-operation to 3 months post-operation]
- pain post-surgery [Time frame: 2 weeks post-operation]
- pain in 3 months [Time frame: 3 months post-operation]
- Change of activity status post-surgery [Time frame: pre-operation to 2 weeks post-operation]
- Change of activity status in 3 months [Time frame: pre-operation to 3 months post-operation]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Taiwan · 1 center
- Department of Physical Medicine and Rehabilitation — Taichung
Identifiers
NCT: NCT05430568 · CE22214A