Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-30 @ 5:06 AM
Study NCT ID:
NCT06325904
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2024-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uniportal VATS Versus Chest Tube for Early Empyema
Sponsor:
Minia University
Organization:
Study Overview
Official Title:
Uniportal Video Assisted Thoracoscopic Surgery (VATS) Debridement Versus Chest Tube Drainage in Early Stage Empyema
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: