Comparison of Video-Assisted Thoracoscopy Surgery and Thoracotomy on Cardiorespiratory Parameters in Patients With Pulmonary Nodules
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Pulmonary function test (Forced expiratory volume in one second)
研究概览
简要总结
The investigators aimed to compare the pre-post operative effects of video-assisted thoracoscopy surgery (VATS) and thoracotomy on pulmonary function, exercise capacity, physical activity level, respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life, fatigue, dyspnea perception and pain in patients with pulmonary nodules.
详细描述
According to global cancer statistics, lung cancer accounts for 11.6% of all cancer cases and it is the most common type of cancer in the world. Surgery is the primary treatment approach, especially in early stages lung cancer. Cardiopulmonary fitness of patients with lung cancer is lower than healthy individuals due to the disease itself and treatments. Pulmonary function, exercise capacity and physical activity level are affected in lung cancer depending on the resected lung tissue and the type of surgery. VATS and thoracotomy surgeries, which are the most preferred techniques in lung cancer, have advantages and disadvantages over each other. There are few studies compared the early effects of two surgeries on the pulmonary function, exercise capacity, physical activity, quality of life and fatigue. And also, no study compared the effects of two surgeries on respiratory muscle endurance and peripheral muscle strength, previously.
According to sample size calculation, at least 15 patients with pulmonary lesion both VATS and thoracotomy groups would be included in the study. The demographic, physical and physiological characteristics were recorded from the patient files. Pulmonary function, functional exercise capacity, physical activity level, respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life, fatigue, dyspnea perception and pain were evaluated pre and two weeks after postoperative term. Primary outcomes were pulmonary function, functional exercise capacity and physical activity level. Secondary outcomes were respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life, fatigue, dyspnea perception and pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between 18-80 years of age,
- •Patients with pulmonary nodule who were planned lobectomy surgery with one of VATS or thoracotomy techniques,
- •Being able to walk,
排除标准
- •Any type of surgery planned except lobectomy,
- •Having heart failure or atrial fibrillation,
- •Having acute viral infections during all assessment,
- •History of acute myocard infarction within last six months,
- •Uncontrolled diabetes or hypertension,
- •Having orthopedic, neurological and psychological disorders that influence the results of study.
结局指标
主要结局
Pulmonary function test (Forced expiratory volume in one second)
时间窗: first day
Forced expiratory volume in one second was evaluated with spirometry according American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The value was represented as percentages.
Pulmonary function test (Forced vital capacity)
时间窗: first day
Forced vital capacity was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.
Pulmonary function test (Forced expiratory volume in one second/Forced vital capacity)
时间窗: first day
Forced expiratory volume in one second/Forced vital capacity was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.
Pulmonary function test (Peak expiratory flow)
时间窗: first day
Peak expiratory flow was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.
Pulmonary function test (Flow rate 25-75% of forced expiratory volume)
时间窗: first day
Flow rate 25-75% of forced expiratory volume was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.
6-minute walk test
时间窗: first day
6-minute walk test were used to assess functional exercise capacity according to the guidelines. The test was repeated twice in the same day with 30 min interval. The highest distance was recorded for analysis.
6-minute stepper test
时间窗: second day
6-minute stepper test were used to assess functional exercise capacity according to the guidelines. The height of the stepper used for test was 20 cm. A cycle of up and down was define as one step. The number of steps was recorded for analysis.
Physical activity assessment
时间窗: second day
Total energy expenditure (joules/day), active energy expenditure (\>3.0 metabolic equivalents (METs)) (joules/day), physical activity duration (\>3.0 METs) (min/day), average MET (METs/day), number of steps (steps/day), lying down (min/day) and sleeping duration (min/day) were measured to interpret the physical activity level of the patients via metabolic holter device. The metabolic holter was worn over triceps brachii muscle of non-dominant extremity for two consecutive days. The patients' activity level were categorized according to number of steps and average MET sums.
次要结局
- Modified borg scale(first and second day)
- Dyspnea perception(first day)
- Pain severity(second day)
- Inspiratory muscle strength test(first day)
- Peripheral muscle strength test(first day)
- Inspiratory muscle endurance test(second day)
- Quality of life scale(first day)
- Fatigue(second day)
- Expiratory muscle strength test(first day)