Comparison of the Outcomes of Surgical Stabilization and Conservative Treatment in Patients With Isolated Minor Rib Fractures: A Prospective Observational Cohort Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 主要终点
- Duration of return to normal activity
研究概览
简要总结
The purpose of this research is to compare the outcomes of surgical stabilization and conservative treatment in patients with isolated minor rib fractures.
详细描述
Isolated minor rib fractures (IMRFs), which is defined by single or two isolated minor rib fractures caused by trauma or stress. Traditionally, rib fractures are managed mainly by surgical stabilization or conservative treatment. In 2018, a systemic review and meta-analysis for patients with multiple rib fractures had revealed a shorter duration of mechanical ventilation, shorter hospital length of stay, and fewer trauma-associated complications in the surgical group than in the non-surgical group. In contrast, IMRFs are seldom life threatening, and compared to extremity fractures, rib fractures do not require matching accurately. Thus, IMRFs are usually treated conservatively. However, the investigators have clinically observed that patients suffering severe pain due to progressive rib displacement may take longer to return to normal activity, have lower quality of life, and even an increased risk of complications. Moreover, limited studies discussed the efficacy of surgical interventions for IMRFs. Therefore, the investigators conduct a prospective observational cohort study to compare the outcomes of surgical stabilization and conservative treatment in patients with IMRFs. The investigators collect patients with IMRFs whose situation were both suitable for surgical and non-surgical interventions. After explanation, patients can decide to undergo conservative or surgical treatment by themselves. The investigators will follow up pain scores, chest X-ray, pulmonary function tests, and duration of return to normal activity. Those data will be statistically analyzed by two-tailed two-sample t-test. This prospective cohort study is supposed to provide more evidence for clinical decision making and optimal management of IMRFs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age ≥ 20 years old.
- •Patient was diagnosed with isolated minor rib fractures by thoracic surgeon.
- •Patient was suitable for both surgical stabilization and conservative treatment.
排除标准
- •Severe trauma associated to other systems.
- •Pathologic fractures: such as fracture due to metastasis or steroid therapy.
- •Unconsciousness or disturbed conscious level.
结局指标
主要结局
Duration of return to normal activity
时间窗: 3 months after operation or after injury
From day of injury to day of return to normal activity
Pain score change at 1 week
时间窗: Change from injury or operation at 1 week
Pain Visual analog scales (Pain VAS) to measure pain intensity. A 10 cm horizontal line will be shown and patients mark on the line representing their perception of their current state. The score range from 0 to 10, with following cutpoints: no pain (0 cm), mild pain(1-4 cm), moderate pain (5-7 cm), and severe pain (8-10 cm).
Pain score change at 3 months
时间窗: Change from injury or operation at 3 months
Pain Visual analog scales (Pain VAS) to measure pain intensity. A 10 cm horizontal line will be shown and patients mark on the line representing their perception of their current state. The score range from 0 to 10, with following cutpoints: no pain (0 cm), mild pain(1-4 cm), moderate pain (5-7 cm), and severe pain (8-10 cm).
次要结局
- Total lung capacity (TLC) change(Change from injury or operation at 3 months)
- Peak expiratory flow (PEF) change(Change from injury or operation at 3 months)
- 36-Item Short Form Survey (SF-36) results(At 3 months after injury or operation)
- Forced vital capacity (FVC) change(Change from injury or operation at 3 months)
- Forced expiratory volume in the first second (FEV1) change(Change from injury or operation at 3 months)
研究者
Tung-Yu, Tiong
Attending surgeon of thoracic surgery
Taipei Medical University Shuang Ho Hospital
