Uniportal VATS Versus Chest Tube for Early Empyema

NCT ID: NCT06325904

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

• 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.

Group Type: ACTIVE_COMPARATOR

Uniportal VATS

Intervention Type: 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

2

• 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.

Group Type: PLACEBO_COMPARATOR

Tube thoracostomy

Intervention Type: PROCEDURE

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

Interventions

Uniportal VATS

• single port video-assisted thoracoscopic surgery in the 5th intercostal space
• performed under general anesthesia.
• pleural fluid/pus was drained
• pleural adhesions was removed

Intervention Type: PROCEDURE

Tube thoracostomy

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

Intervention Type: PROCEDURE

Other Intervention Names

Chest tube

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Yasser Ali Kamal

Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mostafa M Elsayed, MD

Role: PRINCIPAL_INVESTIGATOR

Minia University

Locations

Minia University

Minya, , Egypt

Countries

Egypt

Other Identifiers

9138930

Identifier Type: -

Identifier Source: org_study_id