Quality of Life in Patients With Traumatic Rib Fracture After Rib Fracture Surgery
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|ClinicalTrials.gov Identifier: NCT03487458|
Recruitment Status : Recruiting
First Posted : April 4, 2018
Last Update Posted : April 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rib Fractures||Procedure: Rib Fixation Surgery||Not Applicable|
Traumatic rib fracture is one of the most common thoracic traumas. Patients often complain of severe pain of the fracture site, especially when coughing, sneezing, inhaling and lifting arms. If there is obvious displacement of the rib fracture, there are risks of life-threatening open pneumothorax, hemothorax and internal bleeding. Multiple rib fractures may even cause flail chest, leading to respiratory distress and respiratory failure.
Even patients with mild rib fractures may suffer from pain, causing movement limitations and poor sleep. Those whose occupations require heavy labors may even lose their jobs.
Large wounds and difficulties with localization and fixation made surgical interventions a poor option in the past. Thus, treatment goals were set on pain control and infection prevention. However, in recent years, there are improvements with medical imaging, endoscopy and fracture fixation instruments, so rib fracture fixations become a new treatment option. In addition, patients now ask for higher life quality after the trauma recovery, and not just passively controlling the pain and infection.
Therefore, this study is a prospective study. The investigators enrolled patients with traumatic rib fractures from the National Taiwan University Hospital and Far Eastern Memorial Hospital from July 2017 to July 2018. This study incorporated the use of Short Form-36 and Work Quality Index (WQI) to compare the control groups and the surgical (OP) groups. The participants would complete the questionnaires before surgery and after surgery (before discharge, post-surgery 1 month, 3 months and 6 months).
The goal of this study is to examine the life quality of patients who receive surgical treatment for rib fracture by analyzing patients' response, comorbidity, vital signs (blood pressure, heart rate, respiratory rate, GCS etc.), severity of fracture (AIS, ISS) and medical costs. The investigators hope to find the most suitable method of treatment for patients with rib fractures.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Quality of Life in Patients With Traumatic Rib Fracture After Rib Fracture Surgery: A Prospective Cohort Study|
|Actual Study Start Date :||June 13, 2017|
|Estimated Primary Completion Date :||June 12, 2018|
|Estimated Study Completion Date :||June 12, 2018|
No Intervention: Control
participants receive no surgical treatment
Experimental: Rib Fixation Surgery
participants receive surgical treatment
Procedure: Rib Fixation Surgery
Rib Fixation Surgery
- Short Form-36 (SF-36) [ Time Frame: Assessment of change in SF-36 scores for the control group at admission and after discharge for up to six months and for the surgical group before and after surgery for up to 6 months. ]questionnaire filled by patient
- Work Quality Index (WQI) [ Time Frame: Assessment of change in WQI for the control group at admission and after discharge for up to six months and for the surgical group before and after surgery through study completion for up to 6 months. ]questionnaire filled by patient
- Days of admission [ Time Frame: Assessment of total number of days of hospitalization including ICU stay after admission through study completion for up to 6 months. ]Days of admission in the hospital
- Severity of hemothorax [ Time Frame: Assessment of progression or resolution of hemothorax after simple chest drainage for up to 3 days after chest drainage insertion in the control group and before operation, post-OP day 1, and post-OP day 3 for up to 3 days' post-operation in the surgical ]The severity of hemothorax is evaluated by amount of chest tube drainage measured in milliliters per day.
- Pain [ Time Frame: Every 8 hours during hospitalization for up to 1 month and outpatient follow-up at 1 month, 3 months and 6 months after discharge through study completion for a total of 6 months. ]The Numeric Rating Scale (NRS-11), with a scale from 0 to 10, with 0 as no pain, 10 as extremely painful
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487458
|Contact: Hsien-Chi Liao||886-2-23123456 ext email@example.com|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 10048|
|Contact: Hsien-Chi Liao 886-2-23123456 ext 51611 firstname.lastname@example.org|