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临床试验/NCT04104932
NCT04104932Unknown不适用

Comparison of the Outcomes of Surgical Stabilization and Conservative Treatment in Patients With Isolated Minor Rib Fractures: A Prospective Observational Cohort Study.

Taipei Medical University Shuang Ho Hospital0 个研究点目标入组 120 人开始时间: 2019年7月最近更新:
适应症

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

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

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tung-Yu, Tiong

Attending surgeon of thoracic surgery

Taipei Medical University Shuang Ho Hospital

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