Empyema, PleuralNCT06325904
Uniportal VATS Versus Chest Tube for Early Empyema
A study testing Uniportal VATS and Tube thoracostomy in people with Empyema, Pleural, run by Minia University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Empyema, Pleural
- What is being tested?
- Uniportal VATS and Tube thoracostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed to have empyema and indicated for surgery.
- Age above 18 years old
Who cannot join
- Inability to tolerate single lung ventilation.
- Contraindication for general anesthesia/ medically unfit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Empyema, Pleural
- Being tested
- Uniportal VATS, Tube thoracostomy
- Keywords
- Video-assisted thoracoscopic surgery, Pleura, Empyema
- Medical subject headings
- Empyema, Pleural, Empyema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uniportal VATSProcedure or surgery
- single port video-assisted thoracoscopic surgery in the 5th intercostal space
- performed under general anesthesia.
- pleural fluid/pus was drained
- pleural adhesions was removed
Tube thoracostomyProcedure or surgery
Also called Chest tube
- Chest tube is inserted in 5th mid-axillary line
- performed under local anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Tube thoracostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for further management
Need for further method for pleural fluid drainage or decortication.
Measured: 6 months after inital treatment
Mortality
Postoperative in-hospital or follow-up death.
Measured: 6 months after inital treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Mar 2021
- Primary completion1 Jun 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Empyema, PleuralStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Ali Kamal, Minia University
- Investigators
- Mostafa M Elsayed, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325904
- Sponsor's protocol ID
- 9138930
- Status last verified
- Mar 2024
- First submitted
- 16 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uniportal Video Assisted Thoracoscopic Surgery (VATS) Debridement Versus Chest Tube Drainage in Early Stage Empyema
- ClinicalTrials.gov ID
- NCT06325904
- Acronym / sponsor ID
- 9138930
- Conditions
- Empyema, Pleural
- Keywords
- Video-assisted thoracoscopic surgery, Pleura, Empyema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: 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. |
| 2 | Placebo comparator | Procedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed to have empyema and indicated for surgery.
- Age above 18 years old
Key exclusion criteria (2 listed)
- Inability to tolerate single lung ventilation.
- Contraindication for general anesthesia/ medically unfit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | 1 |
| Tube thoracostomyAlso: Chest tube* Chest tube is inserted in 5th mid-axillary line * performed under local anaesthesia | Procedure or surgery | 2 |
Primary outcome
Need for further management
Time frame: 6 months after inital treatment
Need for further method for pleural fluid drainage or decortication.
Mortality
Time frame: 6 months after inital treatment
Postoperative in-hospital or follow-up death.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mostafa M Elsayed, MD principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uniportal VATS and Tube thoracostomy in people with Empyema, Pleural, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for further management (time frame: 6 months after inital treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.