Uniportal VATS Versus Chest Tube for Early Empyema

Minia University

Status: Completed

Conditions: Empyema, Pleural

Treatments: Procedure: Tube thoracostomy; Procedure: Uniportal VATS

Study type: Interventional

Funder types: Other

Identifiers

NCT06325904

9138930

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

* 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.

Treatment:

Procedure: Uniportal VATS

2

Placebo Comparator group

Description:

* 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.

Treatment:

Procedure: Tube thoracostomy