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Completed

NCT Number: NCT03501524

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut university

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

VATS evacuation

Device

the patient will be randomized to a Video-Assisted thoracoscopy for retained haemothorax

thoracostomy tube

Device

the patient is randomized to reinsertion of a Thoracostomy Tube for retained haemothorax

Other names: intercostal tube reinsertion

Primary outcomes

  1. Duration of hospitalization

    Time frame: average 5-7 days

    number of days spent

Secondary outcomes

  1. number of patients developed empyema

    Time frame: through one month

    the study will be monitored for septic complications , specially empyema.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2018
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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