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

A

Assiut University

Status

Completed

Conditions

Hemothorax; Traumatic

Treatments

Device: VATS evacuation
Device: thoracostomy tube

Study type

Interventional

Funder types

Other

Identifiers

NCT03501524
17100227

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

2 participants in 2 patient groups

VATS evacuation
Experimental group
Description:
patients selected for VATS after failure of first thoracostomy tube drainage
Treatment:
Device: thoracostomy tube
Device: VATS evacuation
thoracostomy tube
Experimental group
Description:
patients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube
Treatment:
Device: thoracostomy tube
Device: VATS evacuation

Trial contacts and locations

1

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Central trial contact

Hussein Khairy Abd_El Aziz Elkhayt, PHD; Mohammed Emad Eldin Omar

Data sourced from clinicaltrials.gov

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