Clinical trial NCT06405841: Costal Fracture Assessment for Relief and Enhancement of Quality of Life
Official title: Costal Fracture Assessment for Relief and Enhancement of Quality of Life - CARE Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rib Fractures
Rib Trauma
Lead sponsor: Ospedali Riuniti Trieste
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients with rib fractures matching inclusion and exclusion criteria will be involved in the 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.

Eligibility criteria: Inclusion Criteria:

* Patients with rib fractures

Exclusion Criteria:

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

Primary outcomes:
measure: Ability to achieve daily living activities (yes/no)
timeFrame: 1, 2, 4, 12 and 24 weeks from the trauma
Secondary outcomes:
measure: Pain killers assumption
timeFrame: 1, 2, 4, 12 and 24 weeks from the trauma
measure: Respiratory infection rate
timeFrame: 1, 2, 4, 12 and 24 weeks from the trauma
measure: Lenght of stay
timeFrame: to 2 years after the trauma
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Department of General Surgery
state: TS
city: Trieste
country: Italy
facility: Department of Thoracic Surgery
state: TS
city: Trieste
country: Italy
facility: Emergency Department
city: Trieste
country: Italy
facility: Intensive Care Unit
Study officials:
References: