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CompletedNCT02014077Updated Jan 29, 2020

VATS ( Video-Assisted Thoracoscopy) Compared to Reinsertion of a Thoracostomy Tube for Persistent Haemothorax

An interventional study of VATS ( Video-Assisted Thoracoscopy ) and Thoracostomy Tube reinsertion in Haemothorax and Empyema, sponsored by University of Cape Town. Completed at 1 site in South Africa. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-01-29.

Sponsored by University of Cape Town · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This is a prospective, randomized study comparing VATS( Video-Assisted Thoracoscopy ) to reinsertion of a Thoracostomy Tube in patients with retained haemothorax. The hypothesis is that early VATS as opposed to reinsertion of a thoracostomy tube , will lead to less complications and shorter hospital stay.

02

Conditions studied

  • Haemothorax
  • Empyema

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Keywords

  • VATS( Video-Assisted Thoracoscopy )
  • Thoracostomy Tube
  • Empyema
  • Thoracotomy
03

In context

Hemothorax

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

This study's enrollment of 62 is below the median of 100 across 21 interventional studies indexed under Hemothorax.

Browse Hemothorax studies →

Lead sponsor

University of Cape Town is the lead sponsor of 116 studies on the registry; 14 are open to participants now.

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

  • Clinical and radiological diagnosis of retained haemothorax
  • Thoracostomy tube blockage or failure to drain

Exclusion criteria

Exclusion Criteria:

  • more than one attempt at thoracostomy tube drainage
  • unable to consent to trial
  • coexisting pathology requiring other interventions
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Active comparator
    Thoracostomy Tube

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

    Procedure: Thoracostomy Tube reinsertion

  • Active comparator
    VATS

    patients selected for VATS after failure of first thoracostomy tube drainage of traumatic haemothorax will undergo a Video-Assisted Thoracoscopic clearance of the persistent/retained haemothorax

    Procedure: VATS ( Video-Assisted Thoracoscopy )

Interventions

  • ProcedureVATS ( Video-Assisted Thoracoscopy )

    the patients were randomized to a Video-Assisted thoracoscopy( VATS )for retained haemothorax

  • ProcedureThoracostomy Tube reinsertion

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

06

What researchers measure

Primary outcomes

  1. duration of hospitalization

    number of days spent in hospital

    Time frame: patients will be followed during their hospital stay, average 5-14 days

Secondary outcomes

  1. number of patients that develop empyema

    each arm of the study will be monitored for septic complications , specifically empyema of the pleural cavity

    Time frame: 2 months form initial injury

Other outcomes

  1. number of patients requiring thoracotomy

    the patients that develop empyema will require a thoracotomy for clearance of the pleural cavity

    Time frame: 2 months from initial injury

07

Study locations

1 site
  • Trauma Center, Groote Schuur Hospital,University of Cape Town
    Cape Town, Western Cape 7925, South Africa
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02014077
Responsible party
Sorin Edu (Dr, University of Cape Town) — Principal investigator
First posted
Dec 17, 2013
Start date
Jan 2014
Primary completion
Nov 2019
Completion
Nov 2019
Last update
Jan 29, 2020

Study contacts

Sorin Edu, MD,FCS
principal investigator · University of Cape Town

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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