Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-29 @ 3:56 AM
Study NCT ID:
NCT05430568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2022-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Post-operation Cardiopulmonary Capacity of Patients Underwent Conventional and Robot-assisted Coronary Artery Bypass Graft and Valve Replacement Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065287', 'term': 'Robotic Surgical Procedures'}, {'id': 'D056346', 'term': 'Sternotomy'}], 'ancestors': [{'id': 'D025321', 'term': 'Surgery, Computer-Assisted'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D012371', 'term': 'Robotics'}, {'id': 'D001331', 'term': 'Automation'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2022-05-29', 'studyFirstSubmitQcDate': '2022-06-23', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of maximal oxygen consumption post-surgery', 'timeFrame': 'pre-operation to 2 weeks post-operation', 'description': 'the change of maximal oxygen consumption from surgery before to 2 weeks after surgery'}, {'measure': 'Change of maximal oxygen consumption in 3 months', 'timeFrame': 'pre-operation to 3 months post-operation', 'description': 'the change of maximal oxygen consumption from before surgery to 3 months after surgery'}, {'measure': 'Change of anaerobic threshold post surgery', 'timeFrame': 'pre-operation to 2 weeks post-operation', 'description': 'the change of the onset of lactate accumulation in blood from before surgery to 2 weeks after surgery'}, {'measure': 'Change of anaerobic threshold in 3 months', 'timeFrame': 'pre-operation to 3 months post-operation', 'description': 'the change of the onset of lactate accumulation in blood from before surgery to 3 months after surgery'}, {'measure': 'Change of six minute walking test result post-surgery', 'timeFrame': 'pre-operation to 2 weeks post-operation', 'description': 'the change of six minute walking test result from before surgery to 2 weeks after surgery'}, {'measure': 'Change of six minute walking test result in 3 months', 'timeFrame': 'pre-operation to 3 months post-operation', 'description': 'the change of six minute walking test result from before surgery to 3 months after surgery'}], 'secondaryOutcomes': [{'measure': 'Change of vital capacity post-surgery', 'timeFrame': 'pre-operation to 2 weeks post-operation', 'description': 'the change of vital capacity during pulmonary function testing from before surgery to 2 weeks after surgery'}, {'measure': 'Change of vital capacity in 3 months', 'timeFrame': 'pre-operation to 3 months post-operation', 'description': 'the change of vital capacity during pulmonary function testing from before surgery to 3 months after surgery'}, {'measure': 'Change of respiratory flow post-surgery', 'timeFrame': 'pre-operation to 2 weeks post-operation', 'description': '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'}, {'measure': 'Change of respiratory flow ratio in 3 months', 'timeFrame': 'pre-operation to 3 months post-operation', 'description': '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'}, {'measure': 'Change of resting heart rate post-surgery', 'timeFrame': 'pre-operation to 2 weeks post-operation', 'description': 'the change of resting heart rate from before surgery to 2 weeks after surgery'}, {'measure': 'Change of resting heart rate in 3 months', 'timeFrame': 'pre-operation to 3 months post-operation', 'description': 'the change of resting heart rate from before surgery to 3 months after surgery'}, {'measure': 'Change of oxygen pulse post-surgery', 'timeFrame': 'pre-operation to 2 weeks post-operation', 'description': 'the change of the maximal value of VO2 divided by heart rate during exercise testing from before surgery to 2 weeks after surgery'}, {'measure': 'Change of oxygen pulse in 3 months', 'timeFrame': 'pre-operation to 3 months post-operation', 'description': 'the change of the maximal value of VO2 divided by heart rate during exercise testing from before surgery to 3 months after surgery'}, {'measure': 'pain post-surgery', 'timeFrame': '2 weeks post-operation', 'description': 'pain visual analog scale score (from 0 to 10, higher score means more painful) for surgery wound pain at 2 weeks after surgery'}, {'measure': 'pain in 3 months', 'timeFrame': '3 months post-operation', 'description': 'pain visual analog scale score (from 0 to 10, higher score means more painful) for surgery wound pain at 3 months after surgery'}, {'measure': 'Change of activity status post-surgery', 'timeFrame': 'pre-operation to 2 weeks post-operation', 'description': 'the change of the Duke Activity Status Index (DASI) score from before surgery to 2 weeks after surgery.\n\nThe DASI is a score ranging from 0 to 58.2. A higher score indicates a better cardiorespiratory fitness.'}, {'measure': 'Change of activity status in 3 months', 'timeFrame': 'pre-operation to 3 months post-operation', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiorespiratory fitness', 'robotic assisted surgery', 'cardiopulmonary exercise testing'], 'conditions': ['Coronary Bypass Graft Stenosis', 'Valvular Heart Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nOnce 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.\n\nCardiopulmonary 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.\n\nThe hypothesis of this study is that patients who undergo robot-assisted surgery will have better cardiopulmonary outcomes than those receive conventional surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'coronary artery and valvular heart disease patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient who undergo surgery for coronary artery bypass graft or valvular replacement.\n\nExclusion Criteria:\n\n* pregnant\n* patients who receive more than one type of surgery\n* severe complications after surgery (ex. respiratory failure, stroke) and stayed in hospital for more than 2 weeks.\n* cannot perform the cardiopulmonary exercise testing\n* other contraindications for cardiopulmonary exercise testing'}, 'identificationModule': {'nctId': 'NCT05430568', 'briefTitle': 'Comparison of Post-operation Cardiopulmonary Capacity of Patients Underwent Conventional and Robot-assisted Coronary Artery Bypass Graft and Valve Replacement Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'Comparison of Post-operation Cardiopulmonary Capacity of Patients Underwent Conventional and Robot-assisted Coronary Artery Bypass Graft and Valve Replacement Surgery', 'orgStudyIdInfo': {'id': 'CE22214A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'bypass graft, sternotomy', 'description': 'patients who have received coronary artery bypass graft surgery with conventional sternotomy procedure'}, {'label': 'bypass graft, robot', 'description': 'patients who have received coronary artery bypass graft surgery with robot-assisted procedure', 'interventionNames': ['Procedure: robot-assisted surgery']}, {'label': 'valvular heart disease, sternotomy', 'description': 'patients who have received valvular replacement surgery with conventional sternotomy procedure'}, {'label': 'valvular heart disease, robot', 'description': 'patients who have received valvular replacement surgery with robot-assisted procedure', 'interventionNames': ['Procedure: robot-assisted surgery']}], 'interventions': [{'name': 'robot-assisted surgery', 'type': 'PROCEDURE', 'otherNames': ['sternotomy'], 'description': '1. traditional sternotomy for coronary bypass graft or valvular replacement\n2. robot-assisted surgery for coronary bypass graft or valvular replacement', 'armGroupLabels': ['bypass graft, robot', 'valvular heart disease, robot']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40705', 'city': 'Taichung', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'Department of Physical Medicine and Rehabilitation', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Yuchun Lee, MD', 'role': 'CONTACT', 'email': 'lyczoj@vghtc.gov.tw', 'phone': '886-4-23592525', 'phoneExt': '3207'}], 'overallOfficials': [{'name': 'Yuchun Lee, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taichung Veterans General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}