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

NCT ID: NCT03501524

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2018-07-30

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.

Conditions

Hemothorax; Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VATS evacuation

patients selected for VATS after failure of first thoracostomy tube drainage

Group Type: EXPERIMENTAL

VATS evacuation

Intervention Type: DEVICE

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

thoracostomy tube

Intervention Type: DEVICE

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

thoracostomy tube

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

Group Type: EXPERIMENTAL

VATS evacuation

Intervention Type: DEVICE

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

thoracostomy tube

Intervention Type: DEVICE

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

Interventions

VATS evacuation

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

Intervention Type: DEVICE

thoracostomy tube

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

Intervention Type: DEVICE

Other Intervention Names

intercostal tube reinsertion

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Emad El-Dein Omar

resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed Khalil salama Ayyad, PHD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut university

Asyut, , Egypt

Countries

Egypt

Other Identifiers

17100227

Identifier Type: -

Identifier Source: org_study_id