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

Surgery--Complications Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04541758
• Other study ID #: ynlc201908
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2021
• Source: Shanghai 6th People's Hospital
• Contact: Yang Li, PHD
• Phone: 13122109923
• Email: drliyang1991[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 238
• Est. completion date: June 30, 2024
• Est. primary completion date: June 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Chest Trauma
• Fractures, Bone
• Rib Fractures
• Surgery--Complications

Intervention

Procedure:
• surgical treatment
surgical treatment and Conservative treatment
• Conservative treatment
Conservative treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 6th People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage improvement of lung function FVC	FVC(forced vital capacity),FVC%:percentage of the expected value	FVC%(One week after treatment)-FVC%(Admitted)
Secondary	Percentage improvement of lung function PEF	PEF(peak expiratory flow ),PEF%:percentage of the expected value	PEF%(One week after treatment)-PEF%(Admitted)
Secondary	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
Secondary	Pleural effusion	Measured by chest CT	Admitted;One week after treatment;One month after treatment;Three month after treatment;Half a year;One year
Secondary	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
Secondary	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
Secondary	Cost of treatment	Sum of all treatment costs	One year
Secondary	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
Secondary	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
Secondary	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
Secondary	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