Comparison of Lung Expansion After Uniportal and Multiportal Video Assisted Thoracic Surgery for Stage II Post Pneumonic Bacterial Empyema Thoracis

NCT ID: NCT07137507

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-05-31

Brief Summary

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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

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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

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Empyema, Pleural Thoracic Empyema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Allocation concealment was maintained using sealed, opaque envelopes prepared by an independent staff member not involved in patient recruitment or data collection. Blinding was applied at the outcome assessment stage, with the radiologists evaluating postoperative lung expansion unaware of the surgical approach used.

Study Groups

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Uniportal Group

Uniportal Video Assisted Thoracic Surgery group

Group Type EXPERIMENTAL

Uniportal VATS

Intervention Type PROCEDURE

Decortication of pleural empyema is done using single-port VATS

Multiportal Group

Multi-portal Video Assisted Thoracic Surgery group

Group Type EXPERIMENTAL

Multi-portal VATS

Intervention Type PROCEDURE

Decortication of pleural empyema is done using two or more ports with VATS

Interventions

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Uniportal VATS

Decortication of pleural empyema is done using single-port VATS

Intervention Type PROCEDURE

Multi-portal VATS

Decortication of pleural empyema is done using two or more ports with VATS

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with stage II empyema
* More than 18 years old patients deemed fit for intervention.
* Both genders
* Unintubated patients

Exclusion Criteria

* Patients with stages I and III empyema
* Patient with TB empyema
* Patient with Fungal empyema
* Patients unfit for general anesthesia.
* Unwilling to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

73 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Health Sciences Lahore

OTHER

Sponsor Role lead

Responsible Party

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Zeeshan Sarwar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammad Shoaib Nabi

Role: STUDY_CHAIR

SIMS, Services Hospital, Lahore

Locations

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Services Institute Of Medical Sciences, Services Hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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IRB/2021/873/SIMS

Identifier Type: -

Identifier Source: org_study_id

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