NCT02014077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

5.8 years

First QC Date

December 5, 2013

Last Update Submit

January 27, 2020

Conditions

HaemothoraxEmpyema

Keywords

VATS( Video-Assisted Thoracoscopy )Thoracostomy TubeEmpyemaThoracotomy

Outcome Measures

Primary Outcomes (1)

  • duration of hospitalization

    number of days spent in hospital

    patients will be followed during their hospital stay, average 5-14 days

Secondary Outcomes (1)

  • number of patients that develop empyema

    2 months form initial injury

Other Outcomes (1)

  • number of patients requiring thoracotomy

    2 months from initial injury

Study Arms (2)

Thoracostomy Tube

ACTIVE COMPARATOR

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

Procedure: Thoracostomy Tube reinsertion

VATS

ACTIVE COMPARATOR

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 )

Interventions

VATS ( Video-Assisted Thoracoscopy )PROCEDURE

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

VATS
Thoracostomy Tube reinsertionPROCEDURE

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

Thoracostomy Tube

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical and radiological diagnosis of retained haemothorax
  • Thoracostomy tube blockage or failure to drain

You may not qualify if:

  • more than one attempt at thoracostomy tube drainage
  • unable to consent to trial
  • coexisting pathology requiring other interventions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trauma Center, Groote Schuur Hospital,University of Cape Town

Cape Town, Western Cape, 7925, South Africa

Location

MeSH Terms

Conditions

HemothoraxEmpyema

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSuppurationInfectionsInflammation

Intervention Hierarchy (Ancestors)

ThoracoscopyEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisVideo-Assisted SurgeryMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Sorin Edu, MD,FCS

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 5, 2013

First Posted

December 17, 2013

Study Start

January 1, 2014

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

January 29, 2020

Record last verified: 2020-01

Locations

ZA(1)