Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of 2-4 Displaced Rib Fractures:A Prospective Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chest Trauma
- Sponsor
- Shanghai 6th People's Hospital
- Enrollment
- 238
- Primary Endpoint
- Percentage improvement of lung function FEV1(Forced expiratory volume in one second)
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Li Yang
Principal Investigator
Shanghai 6th People's Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Percentage improvement of lung function FEV1(Forced expiratory volume in one second)
Time Frame: FEV1%(One week after treatment)-FEV1%(Admitted)
FEV1(Forced expiratory volume in one second)，FEV1% ：percentage of the expected value
Secondary Outcomes
- 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)