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ClinicalTrials.gov ID

NCT06405841

Lead Sponsor

Ospedali Riuniti TriesteOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

950Estimated

Last Update Posted

Nov 21, 2024Actual

Start Date

Jan 2025Estimated

Primary Completion Date

Dec 2026Estimated

Completion Date

Jan 2027Estimated

Official Title

Costal Fracture Assessment for Relief and Enhancement of Quality of Life - CARE Study

Brief 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.

Detailed 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.

• Rib Fractures
• Rib Trauma

• Survey
• Pain management

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Patients with rib fractures

Exclusion Criteria:

• cognitive impairment
• chronic pain due to pathologic fractures
• active cancer

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Ospedali Riuniti TriesteOTHER

manuela.mastronardi@gmail.com0403994152 ext. 0039