Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06405841 |
| Other study ID # |
345_2024H |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 2024 |
| Est. completion date |
September 2026 |
Study information
| Verified date |
May 2024 |
| Source |
Ospedali Riuniti Trieste |
| Contact |
Alan Biloslavo, MD |
| Phone |
+390403994152 |
| Email |
alan.biloslavo[@]asugi.sanita.fvg.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study explores the impact of rib fractures on patient well-being and quality of life,
aiming to identify effective interventions for pain relief and functional improvement. It
investigates the long-term outcomes of conservative treatment for rib fractures, analyzing
factors such as analgesic therapy, hospitalization duration, and respiratory infection rates.
Anticipated results include a comprehensive assessment of patient quality of life and the
potential translational implications for healthcare practice. Furthermore, the study aims to
inform healthcare resource optimization, potentially guiding treatment decisions and
improving patient outcomes within the National Health Service.
Description:
Thoracic trauma remains a significant cause of morbidity and mortality in the traumatized
population. Rib fractures are the most commonly encountered injuries after thoracic trauma,
accounting for approximately 10-15% of all trauma-related hospital admissions. Fractured ribs
serve as surrogate indicators of severe injuries, as most patients suffer additional critical
injuries. Rib fractures are associated with significant long-term morbidity and disability,
resulting in enduring physical impairment, dyspnea, and delayed return to normal daily and
work activities, leading to decreased quality of life. Additionally, previous studies have
demonstrated that up to a quarter of patients with rib fractures experience persistent chest
pain even one year or more after the trauma. In current clinical practice, surgical treatment
of rib fractures is increasingly common, as restoring chest wall integrity appears to
alleviate pain and preserve normal breathing mechanics. While recent studies suggest that rib
fracture fixation may improve lung function, reduce (pulmonary) complication rates, and
shorten hospitalization and intensive care unit (ICU) stays in selected patients, a
definitive consensus on which patients should undergo surgery has yet to be established.
Contributing to the difficulty in determining optimal treatment for patients with rib
fractures is the limited research on long-term quality of life and functional outcomes after
rib fracture fixation or conservative management. Therefore, this study aims to investigate
the quality of life of patients with rib fractures treated conservatively using a dedicated
questionnaire and evaluate the type of analgesic medical therapy used, length of hospital
stay, and rate of respiratory infections.
Expected Results, Translatability, and Impact on the National Health Service (SSN):
Expected Results: It is anticipated that the study will provide a detailed assessment of the
quality of life of patients with rib fractures treated conservatively and their long-term
quality of life. Additionally, the study aims to identify the most effective types of
analgesic medical therapies in controlling rib fracture-related pain, as well as the duration
of hospitalization and rate of respiratory infections associated with conservative treatment.
Translatability: The study results could have broad practical applications in the healthcare
sector, providing guidance on best practices for rib fracture treatment. This could lead to
greater efficacy in rib fracture management protocols, reducing or increasing the need for
surgical interventions to improve patient quality of life.
Impact on the National Health Service (SSN): The study could have a significant impact on the
SSN by providing evidence to optimize healthcare resources through more targeted management
of rib fractures. If the results demonstrate that conservative treatment is ineffective for
certain types of rib fractures, as it entails a longer hospital stay with very late return to
daily and work activities, these patients could be selected for surgical treatment, resulting
in savings for the SSN and an improvement in patient quality of life.
