A Prospective Follow-up of Patients Treated With Muscle Sparing, Minimally Invasive Open Surgical Technique for Unstable Chest Wall After Trauma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Forced expiratory volume percent of the lungs.
研究概览
简要总结
The purpose of this study is to assess the outcome of a muscle sparing, minimally invasive open surgical technique for unstable ribcage injuries after trauma. The investigators will compare the results from the study participants to a historical cohort who were operated with a different surgical technique with large incisions and simultaneous thoracotomy.
详细描述
This is a prospective follow-up study where the investigators aim to study patients who have undergone surgery with a muscle sparing, minimally invasive technique for unstable ribcage after trauma. The investigators plan on seeing the participants as out patients 6 months and 1 year after surgery. The results will be compared to results from a historical cohort with patients who participated in earlier studies with a different surgical method with large incisions and simultaneous thoracotomy. The investigators plan on including 50 patients since a preliminary analysis has suggested this should be enough to notice statistically significant differences between the groups.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chest wall trauma who underwent surgical stabilisation for unstable chest wall using a minimally invasive, muscle sparing technique without thoracotomy or thoracoscopy no more than 6 months prior to inclusion.
排除标准
- •Severe head injury (Abbreviated Injury score (AIS) >3)
- •Spinal injury
- •Neurological or musculoskeletal disease affecting chest wall mobility
研究组 & 干预措施
Minimally invasive
Patients who underwent surgery with a muscle sparing, minimally invasive technique for unstable chest wall after trauma.
干预措施: Minimally invasive surgical fixation of unstable rib cage (Procedure)
Historical control
Patients who underwent surgery with large incisions and simultaneous thoracotomy for unstable chest wall after trauma.
干预措施: Large incision surgical fixation of unstable rib cage. (Procedure)
结局指标
主要结局
Forced expiratory volume percent of the lungs.
时间窗: One year after surgery.
Forced expiratory volume in 1 second divided with forced vital capacity, measured with spirometry.
Vital capacity of the lungs.
时间窗: One year after surgery.
Vital capacity (VC) measured with spirometry.
Peak expiratory flow of the lungs.
时间窗: One year after surgery.
Peak expiratory flow measured with spirometry.
Forced vital capacity of the lungs.
时间窗: One year after surgery.
Forced vital capacity (VC) measured with spirometry.
Forced expiratory volume of the lungs.
时间窗: One year after surgery.
Forced expiratory volume in 1 second (FEV1) measured with spirometry.
次要结局
- Respiratory movement(Six months and one year after surgery.)
- Quality of life EQ-5D-5L(Six months and one year after surgery.)
- Disability(Six months and one year after surgery.)
- Physical activity(Six months and one year after surgery.)
- Radiological healing(One year after surgery.)
- Shoulder mobility(Six months and one year after surgery.)
- Strength of respiratory muscles(Six months and one year after surgery.)
研究者
Erik Öberg Westin
Principal Investigator
Sahlgrenska University Hospital