Comparison of Post-operation Cardiopulmonary Capacity of Patients Underwent Conventional and Robot-assisted Coronary Artery Bypass Graft and Valve Replacement Surgery
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: robot-assisted surgery.
- Кому может быть актуально
- Состояния в реестре: Coronary Bypass Graft Stenosis, Valvular Heart Disease. Базовые параметры: от 20 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Тайвань
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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
Вмешательства
- Процедура robot-assisted surgery
1. traditional sternotomy for coronary bypass graft or valvular replacement 2. robot-assisted surgery for coronary bypass graft or valvular replacement
Первичные конечные точки
- Change of maximal oxygen consumption post-surgery [Срок оценки: pre-operation to 2 weeks post-operation]
- Change of maximal oxygen consumption in 3 months [Срок оценки: pre-operation to 3 months post-operation]
- Change of anaerobic threshold post surgery [Срок оценки: pre-operation to 2 weeks post-operation]
- Change of anaerobic threshold in 3 months [Срок оценки: pre-operation to 3 months post-operation]
- Change of six minute walking test result post-surgery [Срок оценки: pre-operation to 2 weeks post-operation]
- Change of six minute walking test result in 3 months [Срок оценки: pre-operation to 3 months post-operation]
Вторичные конечные точки (12)
- Change of vital capacity post-surgery [Срок оценки: pre-operation to 2 weeks post-operation]
- Change of vital capacity in 3 months [Срок оценки: pre-operation to 3 months post-operation]
- Change of respiratory flow post-surgery [Срок оценки: pre-operation to 2 weeks post-operation]
- Change of respiratory flow ratio in 3 months [Срок оценки: pre-operation to 3 months post-operation]
- Change of resting heart rate post-surgery [Срок оценки: pre-operation to 2 weeks post-operation]
- Change of resting heart rate in 3 months [Срок оценки: pre-operation to 3 months post-operation]
- Change of oxygen pulse post-surgery [Срок оценки: pre-operation to 2 weeks post-operation]
- Change of oxygen pulse in 3 months [Срок оценки: pre-operation to 3 months post-operation]
- pain post-surgery [Срок оценки: 2 weeks post-operation]
- pain in 3 months [Срок оценки: 3 months post-operation]
- Change of activity status post-surgery [Срок оценки: pre-operation to 2 weeks post-operation]
- Change of activity status in 3 months [Срок оценки: pre-operation to 3 months post-operation]
Критерии участия
Критерии включения
- patient who undergo surgery for coronary artery bypass graft or valvular replacement.
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Тайвань · 1 центр
- Department of Physical Medicine and Rehabilitation — Taichung
Идентификаторы
NCT: NCT05430568 · CE22214A