Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05758870
Enrollment
64
Registered
2023-03-08
Start date
2023-04-01
Completion date
2025-12-31
Last updated
2023-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rib Fracture Multiple

Brief 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.

Interventions

PROCEDUREsurgical stabilization of low rib fratures

surgical stabiliazation of rib fractures by internal fixation

OTHERconverstive treatment of low rib fratures

chest wall fixation band

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
EQ-5D-5LOn the day of admissionappraisal of life quality

Secondary

MeasureTime frameDescription
Pain ScoreOn the day of admissionNumber Rating Score, NRS

Other

MeasureTime frameDescription
MortalityOn the day of admissiondeath toll in each group
Length of hospital staythe day from in the hospital to dischargetime of hospitalization
Cost of treatmentthe day from in the hospital to dischargetotal cost of hospitalization expense
Chest discomfortOn the day of admissionchest tightness, foreign body sensation, numbness of surgical incision
AtelectasisOn the day of admissionCT scan show
Duration of analgesic drugthe time of analgesic usement from first treat to the paitent do not use it anymorethe time of analgesic usement from first treat to the paitent do not use it anymore
Total analgesic drug usethe time of analgesic usement from first treat to the paitent do not use it anymoretotal amont of analgesic usement from first treat to the paitent do not use it anymore
Lung function 1On the day of admissionForced vital capacity, FVC
Lung function 2On the day of admissionFirst second forced vital capacity,FEV1
Chronic pain3 months after treatment , 6 month after treatmentpain for more than three months after surgery or trauma, NRS assessment
Pleural effusionOn the day of admissionCT scan show

Contacts

Primary ContactWeiming Wu
wuweiming0427@163.com18930172451

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026