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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Valvular Heart Disease; Coronary Bypass Graft Stenosis
• Intervention / Treatment: Procedure: robot-assisted surgery

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

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Yuchun Lee, MD; Phone Number: 3207 886-4-23592525; Email: lyczoj@vghtc.gov.tw

Study Locations

• Taiwan
  • Taiwan
    • Taichung, Taiwan, Taiwan, 40705
      • Department of Physical Medicine and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

coronary artery and valvular heart disease patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
bypass graft, sternotomy; patients who have received coronary artery bypass graft surgery with conventional sternotomy procedure
bypass graft, robot; patients who have received coronary artery bypass graft surgery with robot-assisted procedure	Procedure: robot-assisted surgery; traditional sternotomy for coronary bypass graft or valvular replacement; robot-assisted surgery for coronary bypass graft or valvular replacement; Other Names: sternotomy
valvular heart disease, sternotomy; patients who have received valvular replacement surgery with conventional sternotomy procedure
valvular heart disease, robot; patients who have received valvular replacement surgery with robot-assisted procedure	Procedure: robot-assisted surgery; traditional sternotomy for coronary bypass graft or valvular replacement; robot-assisted surgery for coronary bypass graft or valvular replacement; Other Names: sternotomy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Investigators: Study Director: Yuchun Lee, MD, Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: May 29, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: cardiorespiratory fitness; cardiopulmonary exercise testing; robotic assisted surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Surgical Procedures, Operative; Technology, Industry, and Agriculture; Automation; Technology; Thoracic Surgical Procedures; Surgery, Computer-Assisted; Robotics; Robotic Surgical Procedures; Sternotomy
• Other Study ID Numbers: CE22214A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No