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

Rib Fracture Multiple Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05758870
• Other study ID #: 20220815
• Status: Not yet recruiting
• Start date: April 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2023
• Source: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Contact: Weiming Wu
• Phone: 18930172451
• Email: wuweiming0427[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Rib Fracture Multiple
• Rib Fractures

Intervention

Procedure:
• surgical stabilization of low rib fratures
surgical stabiliazation of rib fractures by internal fixation

Other:
• converstive treatment of low rib fratures
chest wall fixation band

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Atelectasis	CT scan show	On the day of admission
Other	Atelectasis	CT scan show	1 week after treatment
Other	Atelectasis	CT scan show	2 weeks after treanment
Other	Atelectasis	CT scan show	1 month after treatment
Other	Atelectasis	CT scan show	3 months after treatment
Other	Atelectasis	CT scan show	6 months after treatment
Other	Pleural effusion	CT scan show	On the day of admission
Other	Pleural effusion	CT scan show	1 week after treatment
Other	Pleural effusion	CT scan show	2 weeks after treanment
Other	Pleural effusion	CT scan show	1 months after treatment
Other	Pleural effusion	CT scan show	3 months after treatment
Other	Pleural effusion	CT scan show	6 months after treatment
Other	Mortality	death toll in each group	On the day of admission
Other	Mortality	death toll in each group	1 week after treatment
Other	Mortality	death toll in each group	2 weeks after treanment
Other	Mortality	death toll in each group	1 month after treatment
Other	Mortality	death toll in each group	3 months after treatment
Other	Mortality	death toll in each group	6 months after treatment
Other	Length of hospital stay	time of hospitalization	the day from in the hospital to discharge
Other	Cost of treatment	total cost of hospitalization expense	the day from in the hospital to discharge
Other	Chest discomfort	chest tightness, foreign body sensation, numbness of surgical incision	On the day of admission
Other	Chest discomfort	chest tightness, foreign body sensation, numbness of surgical incision	1 week after treatment
Other	Chest discomfort	chest tightness, foreign body sensation, numbness of surgical incision	2 weeks after treanment
Other	Chest discomfort	chest tightness, foreign body sensation, numbness of surgical incision	1 month after treatment
Other	Chest discomfort	chest tightness, foreign body sensation, numbness of surgical incision	3 months after treatment
Other	Chest discomfort	chest tightness, foreign body sensation, numbness of surgical incision	6 months after treatment
Other	Chronic pain	pain for more than three months after surgery or trauma, NRS assessment	3 months after treatment , 6 month after treatment
Other	Chronic pain	pain for more than three months after surgery or trauma, NRS assessment	6 months after treatment
Other	Duration of analgesic drug	the time of analgesic usement from first treat to the paitent do not use it anymore	the time of analgesic usement from first treat to the paitent do not use it anymore
Other	Total analgesic drug use	total amont of analgesic usement from first treat to the paitent do not use it anymore	the time of analgesic usement from first treat to the paitent do not use it anymore
Other	Lung function 1	Forced vital capacity, FVC	On the day of admission
Other	Lung function 1	Forced vital capacity, FVC	1 week after treatment
Other	Lung function 1	Forced vital capacity, FVC	2 weeks after treanment
Other	Lung function 1	Forced vital capacity, FVC	1 month after treatment
Other	Lung function 1	Forced vital capacity, FVC	3 months after treatment
Other	Lung function 1	Forced vital capacity, FVC	6 months after treatment
Other	Lung function 2	First second forced vital capacity,FEV1	On the day of admission
Other	Lung function 2	First second forced vital capacity, FEV1	1 week after treatment
Other	Lung function 2	First second forced vital capacity, FEV1	2 weeks after treanment
Other	Lung function 2	First second forced vital capacity, FEV1	1 month after treatment
Other	Lung function 2	First second forced vital capacity, FEV1	3 months after treatment
Other	Lung function 2	First second forced vital capacity, FEV1	6 months after treatment
Primary	EQ-5D-5L	appraisal of life quality	On the day of admission
Primary	EQ-5D-5L	appraisal of life quality	1 week after treatment
Primary	EQ-5D-5L	appraisal of life quality	2 weeks after treatment
Primary	EQ-5D-5L	appraisal of life quality	1 month after treatment
Primary	EQ-5D-5L	appraisal of life quality	3 months after treatment
Primary	EQ-5D-5L	appraisal of life quality	6 months after treatment
Secondary	Pain Score	Number Rating Score, NRS	On the day of admission
Secondary	Pain Score	Number Rating Score, NRS	1 week after treatment
Secondary	Pain Score	Number Rating Score, NRS	2 weeks after treanment
Secondary	Pain Score	Number Rating Score, NRS	1 month after treatment
Secondary	Pain Score	Number Rating Score, NRS	3 months after treatment
Secondary	Pain Score	Number Rating Score, NRS	6 months after treatment