An interventional study of Rib Fixation Surgery in Rib Fractures, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-04-04.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
This study is a prospective study. Patients with traumatic rib fractures are divided into control group and surgical (OP) group, depending on whether they undergo rib fracture fixation surgeries. They complete Short Form-36 and Work Quality Index (WQI) 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, Glasgow Coma Scale (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.
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.
126 studies on the registry are indexed under Rib Fractures; 28 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 92 interventional studies indexed under Rib Fractures.
Browse Rib Fractures studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Absolute Indications:
Relative Indications:
Exclusion Criteria:
participants receive no surgical treatment
participants receive surgical treatment
Procedure: Rib Fixation Surgery
Rib Fixation Surgery
Short Form-36 (SF-36)
questionnaire filled by patient
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.
Work Quality Index (WQI)
questionnaire filled by patient
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.
Days of admission
Days of admission in the hospital
Time frame: Assessment of total number of days of hospitalization including ICU stay after admission through study completion for up to 6 months.
Severity of hemothorax
The severity of hemothorax is evaluated by amount of chest tube drainage measured in milliliters per day.
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
Pain
The Numeric Rating Scale (NRS-11), with a scale from 0 to 10, with 0 as no pain, 10 as extremely painful
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.
Started Jun 2017 (actual). Primary completion is estimated for Jun 2018, 11 months after the start.
Of 41 non-industry interventional studies with no phase under Rib Fractures, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 37. This study's planned 11 months is below that.
Counting every sponsor, half of 41 studies reached it within 23 months; a quarter within 15 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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