Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of Rib Fractures

Study Overview
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Brief Summary
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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
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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

Official Title
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Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of 2-4 Displaced Rib Fractures:A Prospective Randomized Controlled Study

Conditions
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Chest Trauma, Rib Fractures, Surgery--Complications

Intervention / Treatment
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* Procedure: surgical treatment
* Procedure: Conservative treatment


Participation Criteria
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Eligibility Criteria
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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 BMI < 30 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 8. Women during pregnancy 9. Flail chest 10. Combined with severe craniocerebral trauma and external abdominal injuries 11. Recent use of clopidogrel, warfarin and aspirin seriously affects blood clotting 12. Self-administered analgesics after injury 13.Massive hemopneumothorax requires emergency surgery 14. Patients who cannot tolerate surgery -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: surgical treatment<br>Minimally invasive internal fixation under spontaneous respiratory anesthesia and analgesic treatment and chest strap fixation | Procedure: surgical treatment<br>* surgical treatment and Conservative treatment<br>Procedure: Conservative treatment<br>* Conservative treatment<br>|
| Experimental: Conservative treatment<br>analgesic treatment and chest strap fixation | Procedure: Conservative treatment<br>* Conservative treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage improvement of lung function FEV1(Forced expiratory volume in one second) | FEV1(Forced expiratory volume in one second)，FEV1% ：percentage of the expected value | FEV1%(One week after treatment)-FEV1%(Admitted) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage improvement of lung function FVC | FVC（forced vital capacity），FVC%：percentage of the expected value | FVC%(One week after treatment)-FVC%(Admitted) | 
| Percentage improvement of lung function PEF | PEF（peak expiratory flow ），PEF%：percentage of the expected value | PEF%(One week after treatment)-PEF%(Admitted) | 
| Pain index | visual analogue scale，VAS（0-10）0：no pain；10：severe pain | Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year | 
| Pleural effusion | Measured by chest CT | Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year | 
| Mortality rate | Deaths associated with this study | Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year | 
| Length of hospital stay | Length of hospital stay | Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year | 
| Cost of treatment | Sum of all treatment costs | One year | 
| Chronic pain | Pain lasting more than three months（It is suggested in the related article that pain lasting more than 3 months is chronic pain）visual analogue scale，VAS（0-10）0：no pain；10：severe pain | Three month after treatment;Half a year;One year | 
| Quality of Life score | The Barthel index of ADL | One week after treatment；One month after treatment;Three month after treatment;Half a year;One year | 
| Time to resume routine work | Time to resume routine work | One week after treatment；One month after treatment;Three month after treatment;Half a year;One year | 
| Duration of analgesic medication | Duration of analgesic medication | intraoperative；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rib fractrue;surgical treatment;Rapid recovery