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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06325904
Other study ID # 9138930
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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