Back to resultsVATS ( Video-Assisted Thoracoscopy) Compared to Reinsertion of a Thoracostomy Tube for Persistent Haemothorax
Primary Purpose
Haemothorax, Empyema
Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
VATS ( Video-Assisted Thoracoscopy )
Thoracostomy Tube reinsertion
Sponsored by
About this trial
This is an interventional treatment trial for Haemothorax focused on measuring VATS( Video-Assisted Thoracoscopy ), Thoracostomy Tube, Empyema, Thoracotomy
Eligibility Criteria
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
Sites / Locations
- Trauma Center, Groote Schuur Hospital,University of Cape Town
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Thoracostomy Tube
VATS
Arm Description
patients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube for traumatic haemothorax
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
Outcomes
Primary Outcome Measures
duration of hospitalization
number of days spent in hospital
Secondary Outcome Measures
number of patients that develop empyema
each arm of the study will be monitored for septic complications , specifically empyema of the pleural cavity
Full Information
NCT ID
NCT02014077
First Posted
December 5, 2013
Last Updated
January 27, 2020
Sponsor
University of Cape Town
1. Study Identification
Unique Protocol Identification Number
NCT02014077
Brief Title
VATS ( Video-Assisted Thoracoscopy) Compared to Reinsertion of a Thoracostomy Tube for Persistent Haemothorax
Official Title
VATS( Video-Assisted Thoracoscopy ) Compared to Reinsertion of a Thoracostomy Tube for Persistent Haemothorax A Single Center Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cape Town
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemothorax, Empyema
Keywords
VATS( Video-Assisted Thoracoscopy ), Thoracostomy Tube, Empyema, Thoracotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thoracostomy Tube
Arm Type
Active Comparator
Arm Description
patients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube for traumatic haemothorax
Arm Title
VATS
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
VATS ( Video-Assisted Thoracoscopy )
Intervention Description
the patients were randomized to a Video-Assisted thoracoscopy( VATS )for retained haemothorax
Intervention Type
Procedure
Intervention Name(s)
Thoracostomy Tube reinsertion
Intervention Description
the patient is randomized to reinsertion of a Thoracostomy Tube for retained haemothorax
Primary Outcome Measure Information:
Title
duration of hospitalization
Description
number of days spent in hospital
Time Frame
patients will be followed during their hospital stay, average 5-14 days
Secondary Outcome Measure Information:
Title
number of patients that develop empyema
Description
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 Pre-specified Outcome Measures:
Title
number of patients requiring thoracotomy
Description
the patients that develop empyema will require a thoracotomy for clearance of the pleural cavity
Time Frame
2 months from initial injury
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sorin Edu, MD,FCS
Organizational Affiliation
University of Cape Town
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trauma Center, Groote Schuur Hospital,University of Cape Town
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
12. IPD Sharing Statement
Learn more about this trial
VATS ( Video-Assisted Thoracoscopy) Compared to Reinsertion of a Thoracostomy Tube for Persistent Haemothorax
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