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CompletedNCT03501524Updated Jan 20, 2025

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

An interventional study of VATS evacuation and thoracostomy tube in Hemothorax; Traumatic, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-01-20.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jul 2017, registered Apr 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hemothorax; Traumatic

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03

In context

Hemothorax

26 studies on the registry are indexed under Hemothorax; 5 are open to participants now.

This study's enrollment of 2 is below the median of 100 across 21 interventional studies indexed under Hemothorax.

Browse Hemothorax studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    VATS evacuation

    patients selected for VATS after failure of first thoracostomy tube drainage

    Device: VATS evacuation · Device: thoracostomy tube

  • Experimental
    thoracostomy tube

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

    Device: VATS evacuation · Device: thoracostomy tube

Interventions

  • DeviceVATS evacuation

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

  • Devicethoracostomy tube

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

    Also known as: intercostal tube reinsertion

06

What researchers measure

Primary outcomes

  1. Duration of hospitalization

    number of days spent

    Time frame: average 5-7 days

Secondary outcomes

  1. number of patients developed empyema

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

    Time frame: through one month

07

Study locations

1 site
  • Assiut university
    Assiut, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2017 to primary completion in Jul 2018, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 8, 2018
First posted
Apr 18, 2018
StartActual
Jul 1, 2017
Primary completionActual
Jul 30, 2018
CompletionActual
Jul 30, 2018
Last update
Jan 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03501524
Lead sponsor
Assiut University
Responsible party
Mohammed Emad El-Dein Omar (resident, Assiut University) — Principal investigator
First posted
Apr 18, 2018
Start date
Jul 1, 2017
Primary completion
Jul 30, 2018
Completion
Jul 30, 2018
Last update
Jan 20, 2025

Study contacts

Mohammed Khalil salama Ayyad, PHD
principal investigator · Assiut University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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