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

Video_ Assisted Thoracoscopic Surgery 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.

Study Overview

• Status: Unknown
• Conditions: Hemothorax; Traumatic
• Intervention / Treatment: Device: VATS evacuation; Device: thoracostomy tube

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 Type: Interventional
• Enrollment (Anticipated): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: VATS evacuation; patients selected for VATS after failure of first thoracostomy tube drainage	Device: VATS evacuation; the patient will be randomized to a Video-Assisted thoracoscopy for retained haemothorax; Device: thoracostomy tube; the patient is randomized to reinsertion of a Thoracostomy Tube for retained haemothorax; Other Names: intercostal tube reinsertion
EXPERIMENTAL: thoracostomy tube; patients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube	Device: VATS evacuation; the patient will be randomized to a Video-Assisted thoracoscopy for retained haemothorax; Device: thoracostomy tube; the patient is randomized to reinsertion of a Thoracostomy Tube for retained haemothorax; Other Names: intercostal tube reinsertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospitalization	number of days spent	average 5-7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients developed empyema	the study will be monitored for septic complications , specially empyema.	through one month

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Mohammed Khalil salama Ayyad, PHD, Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ANTICIPATED): July 30, 2018
• Study Completion (ANTICIPATED): July 30, 2018

Study Registration Dates

• First Submitted: April 8, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (ACTUAL): April 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Pleural Diseases; Hemorrhage; Hemothorax
• Other Study ID Numbers: 17100227

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No