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

January 27, 2020 updated by: Sorin Edu, University of Cape Town

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Trauma Center, Groote Schuur Hospital,University of Cape Town

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Thoracostomy Tube
patients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube for traumatic haemothorax
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
the patients were randomized to a Video-Assisted thoracoscopy( VATS )for retained haemothorax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of hospitalization
Time Frame: patients will be followed during their hospital stay, average 5-14 days
number of days spent in hospital
patients will be followed during their hospital stay, average 5-14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients that develop empyema
Time Frame: 2 months form initial injury
each arm of the study will be monitored for septic complications , specifically empyema of the pleural cavity
2 months form initial injury

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients requiring thoracotomy
Time Frame: 2 months from initial injury
the patients that develop empyema will require a thoracotomy for clearance of the pleural cavity
2 months from initial injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

November 1, 2019

Study Completion (ACTUAL)

November 1, 2019

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (ESTIMATE)

December 17, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 29, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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