跳至主要内容
临床试验/NCT03501524
NCT03501524已完成不适用

Video_ Assisted Thoracoscopic Surgery Evacuation Compared to Reinsertion of Thoracostomy Tube in Persistent Traumatic Haemothorax

Assiut University1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2
试验地点
1
主要终点
Duration of hospitalization

研究概览

简要总结

This is prospective, randomized study comparing VATS (video- Assisted Thoracoscopy) to reinsertion of a thoracostomy tube in patients with persistent traumatic haemothorax. The incidence varies and can be as high as 20%, but in most studies is found to be 1-4% after initial tube thoracostomy for chest trauma. The most accepted complication of retained hemothorax is empyema.Retained hemothorax treatment started by physiotherapy and early withdrawal of tube thoracostomy which lead to more complications as empyema, fibro thorax/entrapped lung, flail chest and diaphragmatic hernia. Early VATS is an alternative treatment for retained hemothorax with evidence that it is a superior intervention when compared to a second tube thoracostomy.

详细描述

Traumatic injuries are a significant cause of morbidity and mortality in our society.At Assiut university hospitals, chest injuries (17.7%) considered as second cause of mortality after head injuries (34.6%) of registered deaths by cause of injury at trauma unit, Assiut university hospitals in a study conducted between,2002-2009. In United States, thoracic injuries are the primary factor in approximately 35% of these deaths, one -third of which occur immediately following the injury, and are contributing in nearly 75% of trauma -related deaths. Up to 15% of patients who sustain thoracic trauma undergo emergent thoracotomy for resuscitation, massive hemothorax, cardiac tamponade, large thoracic wounds, major thoracic vascular injuries, tracheobronchial injuries, or evidence of esophageal injury. The remaining 85-90% of patients who reach the emergency department does not require emergent thoracotomy are initially managed with tube thoracostomy, pain control, pulmonary toilet, and observation .Patients failing this management ultimately require elective thoracotomy for further evaluation and treatment(clotted hemothorax, empyema and diaphragmatic hernia. The current role of VATS in trauma includes evaluation and control of continued chest tube bleeding, early evacuation of retained hemothorax, evacuation and decortication of posttraumatic empyemas, evaluation and limited treatment of suspected diaphragm injuries, evaluation and treatment of persistent air leaks, and evaluation of mediastinal injuries.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • We include for the study all patients admitted to Assiut university hospitals during the time of the study that proved persistent haemothorax that with criteria:
  • Ages that are eligible for study are between 18years to 60 years (adult)
  • Both genders will be included to study.
  • Clinical and radiological diagnosis of persistent haemothorax.
  • Thoracostomy tube blockage or failure to drain within 5-7days.

排除标准

  • More than one thoracostomy tube drainage in the same attempt side.
  • Unable to consent to trial.
  • Coexisting pathology requiring other interventions.
  • Patients that need urgent interventions (hemodynamically unstable, empyema and flail chest).

研究组 & 干预措施

VATS evacuation

Experimental

patients selected for VATS after failure of first thoracostomy tube drainage

干预措施: VATS evacuation (Device)

VATS evacuation

Experimental

patients selected for VATS after failure of first thoracostomy tube drainage

干预措施: thoracostomy tube (Device)

thoracostomy tube

Experimental

patients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube

干预措施: VATS evacuation (Device)

thoracostomy tube

Experimental

patients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube

干预措施: thoracostomy tube (Device)

结局指标

主要结局

Duration of hospitalization

时间窗: average 5-7 days

number of days spent

次要结局

  • number of patients developed empyema(through one month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Emad El-Dein Omar

resident

Assiut University

研究点 (1)

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