Uniportal VATS Versus Chest Tube for Early Empyema

NCT06325904 | Completed

• 1 other identifier: 9138930
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Empyema, Pleural

Keywords

Video-assisted thoracoscopic surgery; Pleura; Empyema

Outcome Measures

Primary Outcomes (2)

• Need for further management

  Need for further method for pleural fluid drainage or decortication.

  6 months after inital treatment

• Mortality

  Postoperative in-hospital or follow-up death.

  6 months after inital treatment

Study Arms (2)

1

ACTIVE COMPARATOR

* 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

2

PLACEBO COMPARATOR

* 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

Interventions

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

1

Tube thoracostomy PROCEDURE

* Chest tube is inserted in 5th mid-axillary line * performed under local anaesthesia

Also known as: Chest tube

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed to have empyema and indicated for surgery.
• Age above 18 years old

You may not qualify if:

• Inability to tolerate single lung ventilation.
• Contraindication for general anesthesia/ medically unfit

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University

Minya, 61111, Egypt

Location

MeSH Terms

Conditions

Empyema, Pleural; Empyema

Interventions

Chest Tubes

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Suppuration; Pleural Diseases; Respiratory Tract Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Mostafa M Elsayed, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: March 22, 2024
• Study Start: March 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)