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Completed

NCT Number: NCT06325904

Uniportal VATS Versus Chest Tube for Early Empyema

This randomized controlled study compared uniportal video-assisted thoracoscopic surgery (U-VATS) versus chest tube drainage for initial (first-line) treatment of stage I (exudative) and stage II (fibrinopurulent) empyema in adult patients (>18 years old). The primary end-point of outcome was the overall success of treatment (no need for re-intervention or death). The main results demonstrated the safety of minimally invasive U-VATS procedure in the initial treatment of early stages of pleural empyema in comparison to traditional chest tube drainage. Initial use of U-VATS was safe and feasible due to postoperative freedom from complex or marked effusion, in addition to significant reduction in the need for additional intervention, postoperative complications, length of hospital stay, and total cost.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minia University

Minya, 61111, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed to have empyema and indicated for surgery.
  • Age above 18 years old

Exclusion criteria

  • Inability to tolerate single lung ventilation.
  • Contraindication for general anesthesia/ medically unfit

Treatment and study plan

Uniportal VATS

Procedure
  • single port video-assisted thoracoscopic surgery in the 5th intercostal space
  • performed under general anesthesia.
  • pleural fluid/pus was drained
  • pleural adhesions was removed

Tube thoracostomy

Procedure
  • Chest tube is inserted in 5th mid-axillary line
  • performed under local anaesthesia

Other names: Chest tube

Primary outcomes

  1. Need for further management

    Time frame: 6 months after inital treatment

    Need for further method for pleural fluid drainage or decortication.

  2. Mortality

    Time frame: 6 months after inital treatment

    Postoperative in-hospital or follow-up death.

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Uniportal Video Assisted Thoracoscopic Surgery (VATS) Debridement Versus Chest Tube Drainage in Early Stage Empyema

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 22, 2024
Registry last updated
Mar 25, 2024

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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