A Prospective Randomized Controlled Study Comparing the Clinical Effects of Surgical and Non-surgical Treatment of Low Rib Fractures

Study Overview
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Brief Summary
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The purpose of this study is to explore the difference between the clinical effects of surgical and non-surgical treatment for patients with low rib fracture, and to explore whether SSRF has more clinical treatment advantages in patients with low rib fracture in a randomized, controlled and prospective manner.

Official Title
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Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Conditions
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Rib Fracture Multiple

Intervention / Treatment
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* Procedure: surgical stabilization of low rib fratures
* Other: converstive treatment of low rib fratures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chest trauma only and unilateral low rib fractures Three rib fractures and more Displacement of the broken end of the fracture (bicortical fracture and not in the same line) Time from injury to hospital < 24 hours Age 18-70 ASA grade I-II Preoperative arterial oxygen partial pressure >60mmHg, carbon dioxide partial pressure <50mmHg The participate is volunteer in the study and sign the informed consent Pain score( Number Rating Scale, NRS) >5 under calm breathing Exclusion Criteria: Difficult airway History of esophageal reflux Myasthenia gravis Coagulation disorders Gastrointestinal ulcer Gastrointestinal bleeding Anesthetic drugs allergy history Asthma Chronic obstructive pulmonary disease Pregnant women

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Research Group<br>surgical stabilization of low rib fracures by internal fixation | Procedure: surgical stabilization of low rib fratures<br>* surgical stabiliazation of rib fractures by internal fixation<br>|
| Controls Group<br>conservative treatment of low rib fractures | Other: converstive treatment of low rib fratures<br>* chest wall fixation band<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D-5L | appraisal of life quality | On the day of admission | 
| EQ-5D-5L | appraisal of life quality | 1 week after treatment | 
| EQ-5D-5L | appraisal of life quality | 2 weeks after treatment | 
| EQ-5D-5L | appraisal of life quality | 1 month after treatment | 
| EQ-5D-5L | appraisal of life quality | 3 months after treatment | 
| EQ-5D-5L | appraisal of life quality | 6 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | Number Rating Score, NRS | On the day of admission | 
| Pain Score | Number Rating Score, NRS | 1 week after treatment | 
| Pain Score | Number Rating Score, NRS | 2 weeks after treanment | 
| Pain Score | Number Rating Score, NRS | 1 month after treatment | 
| Pain Score | Number Rating Score, NRS | 3 months after treatment | 
| Pain Score | Number Rating Score, NRS | 6 months after treatment |