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

Not Applicable

Completed

• Conditions: Empyema; Haemothorax
• Interventions: Procedure: Thoracostomy Tube reinsertion; Procedure: VATS ( Video-Assisted Thoracoscopy )

• Registration Number: NCT02014077
• Lead Sponsor: University of Cape Town

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-11
• Study First Posted: 2013-12-17
• Study Start: 2014-01
• Primary Completion: 2019-11
• Study Completion: 2019-11
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoracostomy Tube	Thoracostomy Tube reinsertion	patients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube for traumatic haemothorax
VATS	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

Primary Outcome Measures

Name	Time	Method
duration of hospitalization	patients will be followed during their hospital stay, average 5-14 days	number of days spent in hospital

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Trauma Center, Groote Schuur Hospital,University of Cape Town; 🇿🇦 Cape Town, Western Cape, South Africa