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

NCT ID: NCT05430568

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2028-05-31

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

Conditions

Coronary Bypass Graft Stenosis; Valvular Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

bypass graft, sternotomy

patients who have received coronary artery bypass graft surgery with conventional sternotomy procedure

No interventions assigned to this group

bypass graft, robot

patients who have received coronary artery bypass graft surgery with robot-assisted procedure

robot-assisted surgery

Intervention Type: PROCEDURE

1. traditional sternotomy for coronary bypass graft or valvular replacement

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

valvular heart disease, sternotomy

patients who have received valvular replacement surgery with conventional sternotomy procedure

No interventions assigned to this group

valvular heart disease, robot

patients who have received valvular replacement surgery with robot-assisted procedure

robot-assisted surgery

Intervention Type: PROCEDURE

1. traditional sternotomy for coronary bypass graft or valvular replacement

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

Interventions

robot-assisted surgery

1. traditional sternotomy for coronary bypass graft or valvular replacement

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

Intervention Type: PROCEDURE

Other Intervention Names

sternotomy

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taichung Veterans General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuchun Lee, MD

Role: STUDY_DIRECTOR

Taichung Veterans General Hospital

Locations

Department of Physical Medicine and Rehabilitation

Taichung, Taiwan, Taiwan

Countries

Taiwan

Central Contacts

Yuchun Lee, MD

Role: CONTACT

lyczoj@vghtc.gov.tw

886-4-23592525 ext. 3207

Other Identifiers

CE22214A

Identifier Type: -

Identifier Source: org_study_id