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

Not yet recruiting

• Conditions: Rib Fracture Multiple
• Interventions: Other: converstive treatment of low rib fratures; Procedure: surgical stabilization of low rib fratures

• Registration Number: NCT05758870
• Lead Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-11
• Study First Submitted QC: 2023-02-24
• Last Update Submitted: 2023-02-24
• Study First Posted: 2023-03-08
• Last Update Posted: 2023-03-08
• Study Start: 2023-04-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls Group	converstive treatment of low rib fratures	conservative treatment of low rib fractures
Research Group	surgical stabilization of low rib fratures	surgical stabilization of low rib fracures by internal fixation

Primary Outcome Measures

Name	Time	Method
EQ-5D-5L	6 months after treatment	appraisal of life quality

Secondary Outcome Measures

Name	Time	Method
Pain Score	6 months after treatment	Number Rating Score, NRS