Video Assisted Thoracoscopic Surgery (VATS) Versus Thoracotomy in Management of Empyema in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- wound size
研究概览
简要总结
Thoracic surgeons have developed a thoracoscopic procedure which is less intrusive method allows complete evacuation and washing of the debris from the pleural cavity. This approach may also have the benefit of less invasive maneuver, a shorter hospital stay and a decreased rate of postoperative complications.
The aim of this study is to evaluate the advantages and disadvantages of the video-assisted thoracoscopic surgery (VATS) approach in comparison with thoracotomy in management of empyema in pediatric patients.
详细描述
comparison between VATS decortication and open thoracotomy in cases of pediatric empyema
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric patients 1 yrs. : ≤ 18 yrs.
- •Patients with empyema due to pneumonia.
- •Patients with empyema had lasted for fewer than 3 weeks.
排除标准
- •Patients < 1 yrs. old.
- •Patients with whom pleural empyema had lasted for more than 3 weeks.
- •Patients with empyema had been caused by trauma.
- •Patients whose parents refuse to be included in the study.
- •Patients with empyema due to ruptured lung abscess.
- •Patients with empyema due to chest wall abscess.
- •Patients with empyema due to rib osteomyelitis.
- •Patients with bronchopleural fistula.
- •Patients with post-surgical empyema.
结局指标
主要结局
wound size
时间窗: after 1week post operative
by centimeters
wound infection
时间窗: during 1week post operative
which degree of infection or if there is a burst wound
air leak duration
时间窗: during 1week post operative
by days and takes how many days to stop air leakage
Early mobilization.
时间窗: during 1week post operative
how many days
hospital stay
时间窗: 1week post operative
by days post operative
pain score
时间窗: during 1week post operative.
through pain score scale 0 No Pain 1-3 Mild Pain (nagging, annoying) 4-6 Moderate Pain 7-10 Severe Pain (disabling)
次要结局
- chronic pain(after 1month post operative)
- avoidance of scoliosis(after 1month post operative)
- shoulder muscle girdle weakness and deformity.(after 1month post operative)
研究者
Ali zein elabdein abd elaleim
Principal investigator
Assiut University