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

NCT05430568 | Not Yet Recruiting

• 1 other identifier: CE22214A
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Bypass Graft Stenosis; Valvular Heart Disease

Keywords

cardiorespiratory fitness; robotic assisted surgery; cardiopulmonary exercise testing

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (12)

• Change of vital capacity post-surgery

  pre-operation to 2 weeks post-operation

• Change of vital capacity in 3 months

  pre-operation to 3 months post-operation

• Change of respiratory flow post-surgery

  pre-operation to 2 weeks post-operation

• Change of respiratory flow ratio in 3 months

  pre-operation to 3 months post-operation

• Change of resting heart rate post-surgery

  pre-operation to 2 weeks post-operation

Study Arms (4)

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

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

Interventions

robot-assisted surgery PROCEDURE

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

Also known as: sternotomy

bypass graft, robot; valvular heart disease, robot

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

coronary artery and valvular heart disease patients

You may qualify if:

• patient who undergo surgery for coronary artery bypass graft or valvular replacement.

You may not qualify if:

• 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

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation

Taichung, Taiwan, 40705, Taiwan

Location

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Robotic Surgical Procedures; Sternotomy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture; Thoracic Surgical Procedures

Study Officials

• Yuchun Lee, MD

  Taichung Veterans General Hospital

  STUDY DIRECTOR

Central Study Contacts

Yuchun Lee, MD

CONTACT

886-4-23592525; lyczoj@vghtc.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: June 24, 2022
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)