Uniportal VATS Versus Chest Tube for Early Empyema

Empyema, Pleural Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06325904
• Other study ID #: 9138930
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2024
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Empyema
• Empyema, Pleural

Intervention

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

Locations

Country	Name	City	State
Egypt	Minia University	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for further management	Need for further method for pleural fluid drainage or decortication.	6 months after inital treatment
Primary	Mortality	Postoperative in-hospital or follow-up death.	6 months after inital treatment