An interventional study of Uniportal VATS and Tube thoracostomy in Empyema, Pleural, sponsored by Minia University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-25.
Sponsored by Minia University · Not applicable, Interventional, and Treatment
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.
33 studies on the registry are indexed under Empyema, Pleural; 11 are open to participants now.
This study's enrollment of 70 is close to the median of 77 across 26 interventional studies indexed under Empyema, Pleural.
Browse Empyema, Pleural studies →Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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* 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.
Procedure: Uniportal VATS
* 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.
Procedure: Tube thoracostomy
* single port video-assisted thoracoscopic surgery in the 5th intercostal space * performed under general anesthesia. * pleural fluid/pus was drained * pleural adhesions was removed
* Chest tube is inserted in 5th mid-axillary line * performed under local anaesthesia
Also known as: Chest tube
Need for further management
Need for further method for pleural fluid drainage or decortication.
Time frame: 6 months after inital treatment
Mortality
Postoperative in-hospital or follow-up death.
Time frame: 6 months after inital treatment
Plan to share: No
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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