Investigation of the Effect of Age and Injury Severity on Short-term Intra-hospital Outcomes After Surgical Stabilized Rib Fractures

Recruiting

• Conditions: Rib Fractures; Rib Trauma; Rib Fracture Multiple; Thorax; Fracture
• Interventions: Procedure: Surgical stabilisation of rib fractures (SSRF); Other: Non-operative management of rib fractures

• Registration Number: NCT06464302
• Lead Sponsor: University Hospital Muenster

Brief Summary

The study aims to investigate the effect of surgical stabilisation of rib fractures (SSRF) on clinical outcomes measured during the hospital stay (mortality, days on a mechanical ventilator, intensive care unit and hospital length of stay, rate of complications). Furthermore, the effect of the patients age and overall injury severity on the outcomes after SSRF will be investigated. We hypothesise that the combination of high age and high injury severity will lead to worse outcomes after SSRF.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-05-01
• Study First Submitted: 2024-05-31
• Study First Submitted QC: 2024-06-12
• Last Update Submitted: 2024-06-12
• Study First Posted: 2024-06-18
• Last Update Posted: 2024-06-18
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• Patients of the University Hospital Muenster
• Coded serial rib fractures (ICD S22.4 and S22.5)
• Treatment for the rib fractures between 2019 and 2023

Exclusion Criteria

• pathological rib fractures (due to suspected malignancy)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Operative	Non-operative management of rib fractures	Patients receiving surgical stabilisation of rib fractures (SSRF) by any operative technique
Operative	Surgical stabilisation of rib fractures (SSRF)	Patients receiving surgical stabilisation of rib fractures (SSRF) by any operative technique
Non-operative	Non-operative management of rib fractures	Patients not receiving surgical stabilisation of rib fractures (SSRF)

Primary Outcome Measures

Name	Time	Method
Intensive care unit length of stay	From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.	The duration in days a patient spent in the intensive care unit from the time of hospital admission to the time of initial hospital discharge.
In hospital-mortality	From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.	Mortality rate from injury to initial hospital discharge, binary

Secondary Outcome Measures

Name	Time	Method
Intubation rate	From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.	Proportion of patients intubated at any time
Clinical outcome	At the time point of initial hospital discharge or at death, whichever came first, assessed up to 2 month.	Clinical outcome according to the Glasgow outcome scale (GOS)
Single organ failure	From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.	Rate of single organ failure
Sepsis	From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.	Rate of Sepsis
Multi-organ failure	From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.	Rate of Multi-organ failure
Lung-failure	From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.	Rate of Lung-failure
Duration of hospital stay	From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.	Duration of hospital stay in days from injury to initial discharge

Trial Locations

Locations (1)

Department for trauma, hand and reconstructive surgery, University hospital Muenster; 🇩🇪 Münster, NRW, Germany