Empyema, PleuralNCT07137507
Comparison of Lung Expansion After Uniportal and Multiportal Video Assisted Thoracic Surgery for Stage II Post Pneumonic Bacterial Empyema Thoracis
A study testing Uniportal VATS and Multi-portal VATS in people with Empyema, Pleural and Thoracic Empyema, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
It was a parallel-armed randomized control study in which 160 participants admitted to the Thoracic Surgery Department, Services Hospital, Lahore were included. The participants were divided into two equal groups (80 in each group). Read more about this study
- Who is it for?
- Ages 18 to 73 years
- Conditions the study is for
- Empyema, Pleural, Thoracic Empyema
- What is being tested?
- Uniportal VATS and Multi-portal VATS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 31 May 2025
- 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 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stage II empyema
- More than 18 years old patients deemed fit for intervention.
- Both genders
- Unintubated patients
Who cannot join
- Patients with stages I and III empyema
- Patient with TB empyema
- Patient with Fungal empyema
- Patients unfit for general anesthesia.
- Unwilling to participate
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Services Institute Of Medical Sciences, Services Hospital
Lahore, Punjab Province
About this study
It was a parallel-armed randomized control study in which 160 participants admitted to the Thoracic Surgery Department, Services Hospital, Lahore were included. The participants were divided into two equal groups (80 in each group). Uniportal Group participants underwent uniportal video assisted thoracic surgery (VATS), while multiportal Group participants were treated with multiportal video assisted thoracic surgery(VATS). Simple consecutive sampling was carried out. Expansion of lung was evaluated postoperatively at the 1st, 3rd, 7th and 15th postoperative day by chest radiograph after uniportal and multiportal VATS.
Read the detailed description
Empyema is a problem that thoracic surgeons deal in everyday practice. The main goal of treatment is evacuating the pus and fibrin deposits in the thoracic cavity for complete lung expansion. Traditionally, the surgical approach was open thoracotomy; then the multiportal video assisted thoracic surgery (VATS) approach became more common. Recently, more surgeons are adopting the uniportal VATS approach, which has become a powerful surgical tool, for the treatment of stage II empyema.
Uniportal and multiportal VATS are a feasible technique in all patients with pleural empyema requiring surgery. In this study, the investigators observed comparable postoperative success rates, no need for conversion, and successful completion of decortication via both multiportal and uniportal approaches. This transition to a single-incision technique was associated with fewer chest tubes, minimal surgical trauma, and no compromise in clinical outcomes.
- Conditions
- Empyema, Pleural, Thoracic Empyema
- Being tested
- Uniportal VATS, Multi-portal VATS
- Keywords
- empyema thoracis, uniportal VATS, Multiportal VATS, Decortication, thoracotomy
- 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
Decortication of pleural empyema is done using single-port VATS
Multi-portal VATSProcedure or surgery
Decortication of pleural empyema is done using two or more ports with VATS
| Study group | Role | What they receive |
|---|---|---|
| Uniportal Group | Experimental | Uniportal Video Assisted Thoracic Surgery group Receives: Procedure: Uniportal VATS |
| Multiportal Group | Experimental | Multi-portal Video Assisted Thoracic Surgery group Receives: Procedure: Multi-portal VATS |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete lung expansion after decortication
Complete expansion of lung after Uniportal or Multiportal VATS was defined as, no residual pneumothorax or fluid collection on the chest radiograph, post - operatively. Lung expansion after surgery will be measured in percentages by calculating percentage of residual pneumothorax or fluid collection and was assessed using chest X-ray. Chest x-rays were performed on post-operative day 1, 3, 7 and 15. Physiologically normal and completely expanded lung is the set parameter for checking and comparing the expansion of operated lung after decortication.
Measured: 15 days
Secondary outcomes (1)
post-operative thoracotomy site pain
Recording of post-operative thoracotomy pain at the site of uniportal or multiportal VATS was also assessed on post-operative day 1, 3 and 7. The Visual Analogue Scale (VAS) is a simple, widely used tool for measuring pain intensity. It consists of a straight line, usually 10 cm in length, with two endpoints:
"0" = no pain "10" (or 100) = worst imaginable pain The patient marks a point on the line that best represents their perceived pain level. The score is then measured in millimeters or centimeters from the "no pain" end, giving a numerical value for pain intensity.
Measured: 07 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Apr 2023
- Primary completion31 Mar 2025
- Study completion31 May 2025
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 University of Health Sciences LahoreThe 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
- Model description
- This study was designed as a parallel-arm randomized controlled trial to compare the effectiveness of uniportal versus multiportal video-assisted thoracic surgery (VATS) in achieving postoperative lung expansion in patients with stage II empyema
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeeshan Sarwar, University of Health Sciences Lahore
- Investigators
- Muhammad Shoaib Nabi, Study chair, SIMS, Services Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137507
- Sponsor's protocol ID
- IRB/2021/873/SIMS
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lung Expansion After Uniportal and Multiportal Video Assisted Thoracic Surgery for Stage II Post Pneumonic Bacterial Empyema Thoracis
- ClinicalTrials.gov ID
- NCT07137507
- Acronym / sponsor ID
- IRB/2021/873/SIMS
- Conditions
- Empyema, Pleural, Thoracic Empyema
- Keywords
- empyema thoracis, uniportal VATS, Multiportal VATS, Decortication, thoracotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 22 Aug 2025 (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.
It was a parallel-armed randomized control study in which 160 participants admitted to the Thoracic Surgery Department, Services Hospital, Lahore were included. The participants were divided into two equal groups (80 in each group). Uniportal Group participants underwent uniportal video assisted thoracic surgery (VATS), while multiportal Group participants were treated with multiportal video assisted thoracic surgery(VATS). Simple consecutive sampling was carried out. Expansion of lung was evaluated postoperatively at the 1st, 3rd, 7th and 15th postoperative day by chest radiograph after uniportal and multiportal VATS.
Detailed description
Empyema is a problem that thoracic surgeons deal in everyday practice. The main goal of treatment is evacuating the pus and fibrin deposits in the thoracic cavity for complete lung expansion. Traditionally, the surgical approach was open thoracotomy; then the multiportal video assisted thoracic surgery (VATS) approach became more common. Recently, more surgeons are adopting the uniportal VATS approach, which has become a powerful surgical tool, for the treatment of stage II empyema.
Uniportal and multiportal VATS are a feasible technique in all patients with pleural empyema requiring surgery. In this study, the investigators observed comparable postoperative success rates, no need for conversion, and successful completion of decortication via both multiportal and uniportal approaches. This transition to a single-incision technique was associated with fewer chest tubes, minimal surgical trauma, and no compromise in clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This study was designed as a parallel-arm randomized controlled trial to compare the effectiveness of uniportal versus multiportal video-assisted thoracic surgery (VATS) in achieving postoperative lung expansion in patients with stage II empyema
| Arm | Type | Receives |
|---|---|---|
| Uniportal Group | Experimental | Procedure: Uniportal VATSUniportal Video Assisted Thoracic Surgery group |
| Multiportal Group | Experimental | Procedure: Multi-portal VATSMulti-portal Video Assisted Thoracic Surgery group |
Who may qualify
- Ages
- 18 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with stage II empyema
- More than 18 years old patients deemed fit for intervention.
- Both genders
- Unintubated patients
Key exclusion criteria (5 listed)
- Patients with stages I and III empyema
- Patient with TB empyema
- Patient with Fungal empyema
- Patients unfit for general anesthesia.
- Unwilling to participate
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 VATSDecortication of pleural empyema is done using single-port VATS | Procedure or surgery | Uniportal Group |
| Multi-portal VATSDecortication of pleural empyema is done using two or more ports with VATS | Procedure or surgery | Multiportal Group |
Primary outcome
complete lung expansion after decortication
Time frame: 15 days
Complete expansion of lung after Uniportal or Multiportal VATS was defined as, no residual pneumothorax or fluid collection on the chest radiograph, post - operatively. Lung expansion after surgery will be measured in percentages by calculating percentage of residual pneumothorax or fluid collection and was assessed using chest X-ray. Chest x-rays were performed on post-operative day 1, 3, 7 and 15. Physiologically normal and completely expanded lung is the set parameter for checking and comparing the expansion of operated lung after decortication.
1 secondary outcome
post-operative thoracotomy site pain
Time frame: 07 days
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 22 Aug 2025.
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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.
Muhammad Shoaib Nabi study chair
SIMS, Services Hospital, Lahore
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 Multi-portal VATS in people with Empyema, Pleural and Thoracic Empyema, run by University of Health Sciences Lahore at 1 site in Pakistan.
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 4 inclusion and 5 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 22 Aug 2025. 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 Pakistan. 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. 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?
complete lung expansion after decortication (time frame: 15 days). 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 22 Aug 2025.