Medico-Economic Analysis of Management of Flail Chest Between Medical Treatment and Surgical Treatment With Stracos
试验速览
- 阶段
- 不适用
- 入组人数
- 310
- 试验地点
- 2
- 主要终点
- Average cost hospitalization
研究概览
简要总结
Optimize the management of polytraumatises with flail chest: surgical treatment Stracos by decreasing the length of stay and the late complications: pain chronicles, quality of life, respiratory function
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with flail chest including bifocal fracture of three or more consecutive ribs in at least two places with or without paradoxical movement
- •The surgical procedure was performed in the first 48 hours after admission
- •pathology with prognosis for survival 6-month-old inferior
排除标准
- •Paraplegia or Tetraplegia
- •Patients having the necessity of neurosurgical treatment or reanimation of neurosurgical
- •Aorta hematoma or rupture
- •ß-HCG positive in women
- •titanium allergy
研究组 & 干预措施
Surgical treatment with Stracos
The patient was placed in the lateral decubitus position. The procedure involved a curvilinear thoracic incision overlying the center of the fractured segments. The intercostal muscles were dissected off the rib on its superior aspect away from the fracture site, and the fracture was then reduced. The investigators then chose the most suitable Stracos, which is to be found in two available sizes, 6 or 9 claws, according to the length of the fracture. The clip chosen was molded according to the shape of the corresponding rib and the claws were crimped using special pliers on and around the fractured rib.The investigators treated only one rib out of two with Stracos, and as for displaced or comminuted fractures, the adjacent rib was wrapped using vicryl suture on the osteosynthesis rib.
干预措施: Thoracic osteosyntheses with Stracos (Device)
Medical treatment
结局指标
主要结局
Average cost hospitalization
时间窗: 4 weeks
Average cost hospitalization without the intensive care cost.The cost of the hospitalization will be calculated by adding the cost of the surgery and hospital stay- time of the surgery-The number of Stracos used by patient
次要结局
- length of hospital stays of the intensive care department(4 weeks)
- length of hospital stays(4 weeks)
- The vital capacity (VC)(visit 3 months, visit 6 months, visit 12 months after the surgery)
- The expiratory reserve volume (ERV)(visit 3 months, visit 6 months, visit 12 months after the surgery)
- Patient Global Assessment to measure quality of life(at visit 7 days, 28 days, 3 months, 6 months and 12 months)
- date of return to work(visit 3 months, 6 months and 12 months)
- occurence of pulmonary infection(12 months of follow up)
- The total lung capacity (TLC)(visit 3 months, visit 6 months, visit 12 months after the surgery)
- Residual volume (RV)(visit 3 months, visit 6 months, visit 12 months after the surgery)
- 6 min walk test (6MWT)(visit 3 months, visit 6 months, visit 12 months after the surgery)
- Visual analog scorer for pain(at visit 7 days, 28 days, 3 months, 6 months and 12 months)