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

NCT ID: NCT02014077

Last Updated: 2020-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-11-30

Brief Summary

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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

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Conditions

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Haemothorax Empyema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Thoracostomy Tube

patients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube for traumatic haemothorax

Group Type ACTIVE_COMPARATOR

Thoracostomy Tube reinsertion

Intervention Type PROCEDURE

the patient is randomized to reinsertion of a Thoracostomy Tube for retained haemothorax

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

Group Type ACTIVE_COMPARATOR

VATS ( Video-Assisted Thoracoscopy )

Intervention Type PROCEDURE

the patients were randomized to a Video-Assisted thoracoscopy( VATS )for retained haemothorax

Interventions

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VATS ( Video-Assisted Thoracoscopy )

the patients were randomized to a Video-Assisted thoracoscopy( VATS )for retained haemothorax

Intervention Type PROCEDURE

Thoracostomy Tube reinsertion

the patient is randomized to reinsertion of a Thoracostomy Tube for retained haemothorax

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cape Town

OTHER

Sponsor Role lead

Responsible Party

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Sorin Edu

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sorin Edu, MD,FCS

Role: PRINCIPAL_INVESTIGATOR

University of Cape Town

Locations

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Trauma Center, Groote Schuur Hospital,University of Cape Town

Cape Town, Western Cape, South Africa

Site Status

Countries

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South Africa

Other Identifiers

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119/2013

Identifier Type: -

Identifier Source: org_study_id

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