Uniportal VATS Versus Chest Tube for Early Empyema

NCT06325904 — Not applicable, Completed, 70 participants, Minia University

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

Registry	NCT06325904
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	70 (Actual)
Sponsor	Minia University (Other)
Conditions	Empyema, Pleural
Interventions	Uniportal VATS, Tube thoracostomy (Procedure)
Dates	start 2021-03-01, primary completion 2023-06-01, completion 2023-12-01, first posted 2024-03-22, last updated 2024-03-25
Locations	1 site in Egypt

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
1	Active comparator	Procedure: Uniportal VATS	* This group included 30 adult patients with stage I/II pleural empyema who operated initially by VATS. * All patients were subjected to the following: 1\. Full history taking. 2.Full clinical examination. 3-Routine Laboratory investigations and Pleural fluid sample analysis. 4- Radiological investigations: Chest X-ray , CT chest. * All patients will be managed by general anesthesia using double lumen endoteracheal tube to achieve single lung ventilation. * All patients were positioned in lateral decubitus position. * Single port skin incisions was made to pass the port through which the camera head and instruments were introduced into the chest . * One chest tubes ws inserted as drains.
2	Placebo comparator	Procedure: Tube thoracostomy	* This group included 30 adult patients with stage I/II pleural empyema who underwent conventional tube thoracotomy. * All patients were subjected to the following: 1\. Full history taking. 2.Full clinical examination. 3-Routine Laboratory investigations and Pleural fluid sample analysis. 4- Radiological investigations: Chest X-ray , CT chest. * The patient is placed in a supine position. * The intercostals pace is opened . * Chest tube is inserted in proper position regarding the site of fluid collection.

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), also known as Chest tube: * Chest tube is inserted in 5th mid-axillary line * performed under local anaesthesia

+Outcome measures

Primary outcomes

Need for further management [6 months after inital treatment]: Need for further method for pleural fluid drainage or decortication.
Mortality [6 months after inital treatment]: Postoperative in-hospital or follow-up death.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Minia University	Minya	Egypt

+Investigators

Mostafa M Elsayed, MD, Principal investigator, Minia University