Uniportal VATS Versus Chest Tube for Early Empyema

March 21, 2024 updated by: Yasser Ali Kamal, Minia University

Uniportal Video Assisted Thoracoscopic Surgery (VATS) Debridement Versus Chest Tube Drainage in Early Stage Empyema

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 61111
        • Minia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: 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
Placebo Comparator: 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.
Procedure: Tube thoracostomy
  • Chest tube is inserted in 5th mid-axillary line
  • performed under local anaesthesia
Other Names:
  • Chest tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for further management
Time Frame: 6 months after inital treatment
Need for further method for pleural fluid drainage or decortication.
6 months after inital treatment
Mortality
Time Frame: 6 months after inital treatment
Postoperative in-hospital or follow-up death.
6 months after inital treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Principal Investigator: Mostafa M Elsayed, MD, Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

March 16, 2024

First Submitted That Met QC Criteria

March 16, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9138930

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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