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Uniportal VATS Versus Chest Tube for Early Empyema

NCT06325904 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-03-25

No results posted yet for this study

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.

Conditions

  • Empyema, Pleural

Interventions

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

PROCEDURE

Tube thoracostomy

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

Sponsors & Collaborators

  • Minia University

    lead OTHER

Principal Investigators

  • Mostafa M Elsayed, MD · Minia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-06-01
Completion
2023-12-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06325904 on ClinicalTrials.gov