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Completed

NCT Number: NCT02014077

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

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.

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Key information

Conditions

Haemothorax Empyema Hemorrhage Hemothorax Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Diseases Respiratory Tract Diseases Suppuration

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trauma Center, Groote Schuur Hospital,University of Cape Town

Cape Town, Western Cape, 7925, South Africa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VATS ( Video-Assisted Thoracoscopy )

Procedure

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

Thoracostomy Tube reinsertion

Procedure

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

Primary outcomes

  1. duration of hospitalization

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

    number of days spent in hospital

Secondary outcomes

  1. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Cape Town

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Dec 17, 2013
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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