HaemothoraxNCT02014077
VATS ( Video-Assisted Thoracoscopy) Compared to Reinsertion of a Thoracostomy Tube for Persistent Haemothorax
A study testing VATS ( Video-Assisted Thoracoscopy ) and Thoracostomy Tube reinsertion in people with Haemothorax and Empyema, run by University of Cape Town at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Haemothorax, Empyema
- What is being tested?
- VATS ( Video-Assisted Thoracoscopy ) and Thoracostomy Tube reinsertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jan 2014to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical and radiological diagnosis of retained haemothorax
- Thoracostomy tube blockage or failure to drain
Who cannot join
- more than one attempt at thoracostomy tube drainage
- unable to consent to trial
- coexisting pathology requiring other interventions
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Trauma Center, Groote Schuur Hospital,University of Cape Town
Cape Town, Western Cape, 7925
About this study
Official title: VATS( Video-Assisted Thoracoscopy ) Compared to Reinsertion of a Thoracostomy Tube for Persistent Haemothorax A Single Center Prospective Randomized Study
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.
- Conditions
- Haemothorax, Empyema
- Being tested
- VATS ( Video-Assisted Thoracoscopy ), Thoracostomy Tube reinsertion
- Keywords
- VATS( Video-Assisted Thoracoscopy ), Thoracostomy Tube, Empyema, Thoracotomy
- Medical subject headings
- Hemothorax, Empyema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VATS ( Video-Assisted Thoracoscopy )Procedure or surgery
the patients were randomized to a Video-Assisted thoracoscopy( VATS )for retained haemothorax
Thoracostomy Tube reinsertionProcedure or surgery
the patient is randomized to reinsertion of a Thoracostomy Tube for retained haemothorax
| Study group | Role | What they receive |
|---|---|---|
| Thoracostomy Tube | Active comparator | patients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube for traumatic haemothorax Receives: Procedure: Thoracostomy Tube reinsertion |
| VATS | Active comparator | 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 Receives: Procedure: VATS ( Video-Assisted Thoracoscopy ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of hospitalization
number of days spent in hospital
Measured: 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
Measured: 2 months form initial injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemothoraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sorin Edu, University of Cape Town
- Investigators
- Sorin Edu, MD,FCS, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014077
- Sponsor's protocol ID
- 119/2013
- Status last verified
- Jan 2020
- First submitted
- 5 Dec 2013
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VATS( Video-Assisted Thoracoscopy ) Compared to Reinsertion of a Thoracostomy Tube for Persistent Haemothorax A Single Center Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02014077
- Acronym / sponsor ID
- 119/2013
- Conditions
- Haemothorax, Empyema
- Keywords
- VATS( Video-Assisted Thoracoscopy ), Thoracostomy Tube, Empyema, Thoracotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracostomy Tube | Active comparator | Procedure: Thoracostomy Tube reinsertionpatients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube for traumatic haemothorax |
| VATS | Active comparator | Procedure: VATS ( Video-Assisted Thoracoscopy )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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical and radiological diagnosis of retained haemothorax
- Thoracostomy tube blockage or failure to drain
Key exclusion criteria (3 listed)
- more than one attempt at thoracostomy tube drainage
- unable to consent to trial
- coexisting pathology requiring other interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VATS ( Video-Assisted Thoracoscopy )the patients were randomized to a Video-Assisted thoracoscopy( VATS )for retained haemothorax | Procedure or surgery | VATS |
| Thoracostomy Tube reinsertionthe patient is randomized to reinsertion of a Thoracostomy Tube for retained haemothorax | Procedure or surgery | Thoracostomy Tube |
Primary outcome
duration of hospitalization
Time frame: patients will be followed during their hospital stay, average 5-14 days
number of days spent in hospital
1 secondary outcome
number of patients that develop empyema
Time frame: 2 months form initial injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sorin Edu, MD,FCS principal investigator
University of Cape Town
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VATS ( Video-Assisted Thoracoscopy ) and Thoracostomy Tube reinsertion in people with Haemothorax and Empyema, run by University of Cape Town at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of hospitalization (time frame: patients will be followed during their hospital stay, average 5-14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.