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

Empyema Clinical Trial

Official title:

VATS( Video-Assisted Thoracoscopy ) Compared to Reinsertion of a Thoracostomy Tube for Persistent Haemothorax A Single Center Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02014077
• Other study ID #: 119/2013
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: November 2019

Study information

• Verified date: January 2020
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Empyema
• Haemothorax
• Hemothorax

Intervention

Procedure:
• VATS ( Video-Assisted Thoracoscopy )
the patients were randomized to a Video-Assisted thoracoscopy( VATS )for retained haemothorax
• Thoracostomy Tube reinsertion
the patient is randomized to reinsertion of a Thoracostomy Tube for retained haemothorax

Locations

Country	Name	City	State
South Africa	Trauma Center, Groote Schuur Hospital,University of Cape Town	Cape Town	Western Cape

Sponsors (1)

Lead Sponsor	Collaborator
University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	number of patients requiring thoracotomy	the patients that develop empyema will require a thoracotomy for clearance of the pleural cavity	2 months from initial injury
Primary	duration of hospitalization	number of days spent in hospital	patients will be followed during their hospital stay, average 5-14 days
Secondary	number of patients that develop empyema	each arm of the study will be monitored for septic complications , specifically empyema of the pleural cavity	2 months form initial injury