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

• Sponsor: University of Cape Town (Other)
• Overall Status: Completed
• CT.gov ID: NCT02014077
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arms: 2
• Duration (Months): 70
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Haemothorax; Empyema	Procedure: VATS ( Video-Assisted Thoracoscopy ); Procedure: Thoracostomy Tube reinsertion	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: VATS( Video-Assisted Thoracoscopy ) Compared to Reinsertion of a Thoracostomy Tube for Persistent Haemothorax A Single Center Prospective Randomized Study
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Nov 1, 2019
• Actual Study Completion Date: Nov 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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; 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	Procedure: VATS ( Video-Assisted Thoracoscopy ); the patients were randomized to a Video-Assisted thoracoscopy( VATS )for retained haemothorax

Outcome Measures

Primary Outcome Measures

1. duration of hospitalization [patients will be followed during their hospital stay, average 5-14 days]

   number of days spent in hospital

Secondary Outcome Measures

1. number of patients that develop empyema [2 months form initial injury]

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

Other Outcome Measures

1. number of patients requiring thoracotomy [2 months from initial injury]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Trauma Center, Groote Schuur Hospital,University of Cape Town	Cape Town	Western Cape	South Africa	7925

Sponsors and Collaborators

• University of Cape Town

Investigators

• Principal Investigator: Sorin Edu, MD,FCS, University of Cape Town

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sorin Edu, Dr, University of Cape Town
• ClinicalTrials.gov Identifier: NCT02014077
• Other Study ID Numbers: 119/2013
• First Posted: Dec 17, 2013
• Last Update Posted: Jan 29, 2020
• Last Verified: Jan 1, 2020

• Keywords provided by Sorin Edu, Dr, University of Cape Town: VATS( Video-Assisted Thoracoscopy ); Thoracostomy Tube; Empyema; Thoracotomy
• Additional relevant MeSH terms: Empyema; Hemothorax

Study Results

No Results Posted as of Jan 29, 2020