Impact of Lobectomy Versus Sublobar Resection on Cardiorespiratory Fitness: An Observational Study Based on Cardiopulmonary Exercise Testing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 604
- 试验地点
- 1
- 主要终点
- Change in peak oxygen uptake (peak VO2)
研究概览
简要总结
This observational study will compare changes in cardiorespiratory fitness after lobectomy and sublobar resection. Sublobar resection includes segmentectomy and wedge resection. Patients who can undergo pulmonary resection and meet the eligibility criteria will be studied during routine clinical care; the research will not assign the surgical procedure or add a study-specific intervention.
Cardiopulmonary exercise testing (CPET) and pulmonary function testing will be performed before surgery and at routine follow-up visits 6 and 12 months after surgery. Changes from the preoperative assessment will be compared within each surgical group and between the two groups. The study will also examine the relationship between CPET measurements and postoperative complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Able to understand the study and provide written informed consent.
- •Considered able to tolerate surgical treatment, including segmentectomy, lobectomy, or wedge resection, following preoperative assessment, including cardiac and pulmonary function testing.
排除标准
- •Pregnant or breastfeeding.
- •Any absolute contraindication to CPET.
- •A history of severe heart disease, heart failure, myocardial infarction, or an episode of angina within the previous 3 months.
- •A cerebrovascular event, including cerebral infarction or cerebral hemorrhage, within the previous 3 months.
- •A psychiatric illness that prevents communication.
- •Unable to cooperate with the examinations. -
研究组 & 干预措施
Lobectomy
干预措施: Lobectomy (Procedure)
Sublobar Resection
干预措施: Sublobar Resection (Procedure)
结局指标
主要结局
Change in peak oxygen uptake (peak VO2)
时间窗: Baseline and at 6 and 12 months after surgery
Change in maximum oxygen uptake per kilogram of body weight
时间窗: Baseline and at 6 and 12 months after surgery
Change in maximum oxygen uptake as a percentage of the predicted value
时间窗: Baseline and at 6 and 12 months after surgery
Change in anaerobic threshold (AT)
时间窗: Baseline and at 6 and 12 months after surgery
次要结局
- Change in forced vital capacity (FVC)(Baseline and at 6 and 12 months after surgery)
- Change in forced expiratory volume in one second (FEV1)(Baseline and at 6 and 12 months after surgery)
- Change in Lung Volume and Lung Volume as a Percentage of the Preoperative Value(Baseline and at 6 and 12 months after surgery)
- Change in the FEV1/FVC ratio(Baseline and at 6 and 12 months after surgery)
- Incidence of postoperative complications(30 days after surgery)