- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02014077
VATS ( Video-Assisted Thoracoscopy) Compared to Reinsertion of a Thoracostomy Tube for Persistent Haemothorax
January 27, 2020 updated by: Sorin Edu, University of Cape Town
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Western Cape
-
Cape Town, Western Cape, South Africa, 7925
- Trauma Center, Groote Schuur Hospital,University of Cape Town
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical and radiological diagnosis of retained haemothorax
- Thoracostomy tube blockage or failure to drain
Exclusion Criteria:
- more than one attempt at thoracostomy tube drainage
- unable to consent to trial
- coexisting pathology requiring other interventions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Thoracostomy Tube
patients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube for traumatic haemothorax
|
the patient is randomized to reinsertion of a Thoracostomy Tube for retained haemothorax
|
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
|
the patients were randomized to a Video-Assisted thoracoscopy( VATS )for retained haemothorax
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
duration of hospitalization
Time Frame: patients will be followed during their hospital stay, average 5-14 days
|
number of days spent in hospital
|
patients will be followed during their hospital stay, average 5-14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of patients that develop empyema
Time Frame: 2 months form initial injury
|
each arm of the study will be monitored for septic complications , specifically empyema of the pleural cavity
|
2 months form initial injury
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of patients requiring thoracotomy
Time Frame: 2 months from initial injury
|
the patients that develop empyema will require a thoracotomy for clearance of the pleural cavity
|
2 months from initial injury
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sorin Edu, MD,FCS, University of Cape Town
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (ACTUAL)
November 1, 2019
Study Completion (ACTUAL)
November 1, 2019
Study Registration Dates
First Submitted
December 5, 2013
First Submitted That Met QC Criteria
December 11, 2013
First Posted (ESTIMATE)
December 17, 2013
Study Record Updates
Last Update Posted (ACTUAL)
January 29, 2020
Last Update Submitted That Met QC Criteria
January 27, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 119/2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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