VATS Evacuation Compared to Reinsertion of Thoracostomy Tube in Persistent Traumatic Haemothorax

Not Applicable

• Conditions: Hemothorax; Traumatic
• Interventions: Device: VATS evacuation; Device: thoracostomy tube

• Registration Number: NCT03501524
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-07-01
• Status Verified: 2018-04
• Study First Submitted: 2018-04-08
• Study First Submitted QC: 2018-04-16
• Last Update Submitted: 2018-04-16
• Study First Posted: 2018-04-18
• Last Update Posted: 2018-04-18
• Primary Completion: 2018-07-30
• Study Completion: 2018-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

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:

1. Ages that are eligible for study are between 18years to 60 years (adult)
2. Both genders will be included to study.
3. Clinical and radiological diagnosis of persistent haemothorax.
4. Thoracostomy tube blockage or failure to drain within 5-7days.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VATS evacuation	thoracostomy tube	patients selected for VATS after failure of first thoracostomy tube drainage
VATS evacuation	VATS evacuation	patients selected for VATS after failure of first thoracostomy tube drainage
thoracostomy tube	thoracostomy tube	patients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube
thoracostomy tube	VATS evacuation	patients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube

Primary Outcome Measures

Name	Time	Method
Duration of hospitalization	average 5-7 days	number of days spent

Secondary Outcome Measures

Name	Time	Method
number of patients developed empyema	through one month	the study will be monitored for septic complications , specially empyema.

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt