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
1 other identifier
observational
64
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2023
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2023
CompletedFirst Posted
Study publicly available on registry
March 8, 2023
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMarch 8, 2023
February 1, 2023
2.8 years
February 11, 2023
February 24, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
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 Outcomes (6)
Pain Score
On the day of admission
Pain Score
1 week after treatment
Pain Score
2 weeks after treanment
Pain Score
1 month after treatment
Pain Score
3 months after treatment
- +1 more secondary outcomes
Other Outcomes (42)
Atelectasis
On the day of admission
Atelectasis
1 week after treatment
Atelectasis
2 weeks after treanment
- +39 more other outcomes
Study Arms (2)
Research Group
surgical stabilization of low rib fracures by internal fixation
Controls Group
conservative treatment of low rib fractures
Interventions
surgical stabiliazation of rib fractures by internal fixation
Eligibility Criteria
patient with multiple rib fractures combines with low rib fractures
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Thoracic Surgery
Study Record Dates
First Submitted
February 11, 2023
First Posted
March 8, 2023
Study Start
April 1, 2023
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
March 8, 2023
Record last verified: 2023-02