Clinical trial NCT04541758: Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of Rib Fractures
Official title: Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of 2-4 Displaced Rib Fractures:A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chest Trauma
Rib Fractures
Surgery--Complications
Keywords: rib fractrue;surgical treatment;Rapid recovery
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. Unilateral thoracic trauma, fractured ends of rib fractures displaced 2-4 places
2. Displaced fracture（CT image shows double displacement of bone cortex） located in the 3rd to 10th rib
3. The number of broken ends of displaced fractures is greater than that of undisplaced fractures
4. The length of time from injury to hospitalization \<24 hours
5. Age range（18-70）
6. ASA grade I-II
7. BMI \< 30
8. Preoperative partial arterial oxygen pressure \>60mmHg, partial arterial carbon dioxide pressure \<50mmHg

Exclusion Criteria:

1. Difficult airway
2. History of esophageal reflux
3. Myasthenia gravis
4. Abnormal coagulation system
5. History of gastrointestinal ulcer or bleeding
6. 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

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Primary outcomes:
measure: Percentage improvement of lung function FEV1(Forced expiratory volume in one second)
timeFrame: FEV1%(One week after treatment)-FEV1%(Admitted)
Secondary outcomes:
measure: Percentage improvement of lung function FVC
timeFrame: FVC%(One week after treatment)-FVC%(Admitted)
measure: Percentage improvement of lung function PEF
timeFrame: PEF%(One week after treatment)-PEF%(Admitted)
measure: Pain index
timeFrame: Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
measure: Pleural effusion
timeFrame: Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
measure: Mortality rate
timeFrame: Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
measure: Length of hospital stay
timeFrame: Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
measure: Cost of treatment
timeFrame: One year
measure: Chronic pain
timeFrame: Three month after treatment;Half a year;One year
measure: Quality of Life score
timeFrame: One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
measure: Time to resume routine work
timeFrame: One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
measure: Duration of analgesic medication
timeFrame: intraoperative；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Yi Yang, PHD
role: STUDY_DIRECTOR
affiliation: Shanghai 6th People's Hospital
name: Zongli Gao, PHD
role: STUDY_CHAIR
affiliation: Shanghai 6th People's Hospital
name: Yonghong Zhao, PHD
role: STUDY_CHAIR
affiliation: Shanghai 6th People's Hospital
name: Weiming Wu, PHD
role: STUDY_CHAIR
affiliation: Shanghai 6th People's Hospital
name: Weigang Zhao, PHD
role: STUDY_CHAIR
affiliation: Shanghai 6th People's Hospital
name: Tiancheng Zhao, PHD
role: STUDY_CHAIR
affiliation: Shanghai 6th People's Hospital
name: Xiang Guo, PHD
role: STUDY_CHAIR
affiliation: Shanghai 6th People's Hospital
name: Lei Wang, PHD
role: STUDY_CHAIR
affiliation: Shanghai 6th People's Hospital
name: Weiwei He, PHD
role: STUDY_CHAIR
References: