Uniportal VATS Versus Chest Tube for Early Empyema

Not Applicable

Completed

• Conditions: Empyema, Pleural
• Interventions: Procedure: Tube thoracostomy; Procedure: Uniportal VATS

• Registration Number: NCT06325904
• Lead Sponsor: Minia University

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

Not available

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-12-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-16
• Study First Submitted QC: 2024-03-16
• Last Update Submitted: 2024-03-21
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	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.
1	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Minia University; 🇪🇬 Minya, Egypt