Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of 2-4 Displaced Rib Fractures:A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 238
- 主要终点
- Percentage improvement of lung function FEV1(Forced expiratory volume in one second)
研究概览
简要总结
Open, randomized, parallel controlled prospective clinical study design was used in this study.Subjects were patients with 2-4 displaced non-flail rib fractures.Operation group (Group 1) : minimally invasive internal fixation operation group under spontaneous breathing anesthesia.In the operation group of minimally invasive internal fixation under autonomic respiratory anesthesia, the fracture was determined preoperatively by chest CT+ three-dimensional reconstruction of the ribs, and the optimal incision location was determined. The fracture was exposed through as many small incisions as possible, and fixed with titanium plate or clon-type plate. During the operation, the autonomic respiratory anesthesia and paraviral nerve block technology was adopted.In the conservative group (group 2), routine treatment measures such as analgesia and chest strap fixed were adopted.The purpose of this study was to evaluate the safety, feasibility, and efficacy of minimally invasive and conservative treatment for rib fractures with different Numbers of displaced ends.
详细描述
An open, randomized, parallel controlled prospective clinical study design type was used in this study. Subjects were patients with two to four displaced non-flail chest fractures of the ribs. Operation group (Group 1) : minimally invasive internal fixation operation group under spontaneous breathing anesthesia. In the operation group of minimally invasive internal fixation under autonomic respiratory anesthesia, the fracture was determined preoperatively by chest CT+ three-dimensional reconstruction of the ribs, and the optimal incision location was determined. The fracture was exposed through as many small incisions as possible, and fixed with titanium plate or clon-type plate. During the operation, the autonomic respiratory anesthesia and paraviral nerve block technology was adopted. In the conservative group (group 2), routine treatment measures such as analgesia, hemostasis and chest band fixation were adopted. The effects of the two treatments on lung function, pain index, complications and QoL were evaluated. It provides theoretical basis for the treatment of rib fracture
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral thoracic trauma, fractured ends of rib fractures displaced 2-4 places
- •Displaced fracture（CT image shows double displacement of bone cortex） located in the 3rd to 10th rib
- •The number of broken ends of displaced fractures is greater than that of undisplaced fractures
- •The length of time from injury to hospitalization <24 hours
- •Age range（18-70）
- •ASA grade I-II
- •Preoperative partial arterial oxygen pressure >60mmHg, partial arterial carbon dioxide pressure <50mmHg
排除标准
- •Difficult airway
- •History of esophageal reflux
- •Myasthenia gravis
- •Abnormal coagulation system
- •History of gastrointestinal ulcer or bleeding
- •History of anaesthesia related drug allergy
- •A history of asthma or chronic obstructive emphysema
- •Women during pregnancy
- •Flail chest
- •Combined with severe craniocerebral trauma and external abdominal injuries
- •Recent use of clopidogrel, warfarin and aspirin seriously affects blood clotting
- •Self-administered analgesics after injury
- •13.Massive hemopneumothorax requires emergency surgery
- •Patients who cannot tolerate surgery
结局指标
主要结局
Percentage improvement of lung function FEV1(Forced expiratory volume in one second)
时间窗: FEV1%(One week after treatment)-FEV1%(Admitted)
FEV1(Forced expiratory volume in one second)，FEV1% ：percentage of the expected value
次要结局
- Percentage improvement of lung function FVC(FVC%(One week after treatment)-FVC%(Admitted))
- Pain index(Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year)
- Cost of treatment(One year)
- Pleural effusion(Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year)
- Mortality rate(Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year)
- Chronic pain(Three month after treatment;Half a year;One year)
- Duration of analgesic medication(intraoperative；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year)
- Percentage improvement of lung function PEF(PEF%(One week after treatment)-PEF%(Admitted))
- Length of hospital stay(Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year)
- Quality of Life score(One week after treatment；One month after treatment;Three month after treatment;Half a year;One year)
- Time to resume routine work(One week after treatment；One month after treatment;Three month after treatment;Half a year;One year)
研究者
Li Yang
Principal Investigator
Shanghai 6th People's Hospital