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

NCT07137507 | Completed

• 1 other identifier: IRB/2021/873/SIMS
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Empyema, Pleural; Thoracic Empyema

Keywords

empyema thoracis; uniportal VATS; Multiportal VATS; Decortication; thoracotomy

Outcome Measures

Primary Outcomes (1)

• 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.

  15 days

Secondary Outcomes (1)

• post-operative thoracotomy site pain

  07 days

Study Arms (2)

Uniportal Group

EXPERIMENTAL

Uniportal Video Assisted Thoracic Surgery group

Procedure: Uniportal VATS

Multiportal Group

EXPERIMENTAL

Multi-portal Video Assisted Thoracic Surgery group

Procedure: Multi-portal VATS

Interventions

Uniportal VATS PROCEDURE

Decortication of pleural empyema is done using single-port VATS

Uniportal Group

Multi-portal VATS PROCEDURE

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

Multiportal Group

Eligibility Criteria

• Age: 18 Years - 73 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with stages I and III empyema
• Patient with TB empyema
• Patient with Fungal empyema
• Patients unfit for general anesthesia.
• Unwilling to participate

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

Study Sites (1)

Services Institute Of Medical Sciences, Services Hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Empyema, Pleural; Empyema

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Suppuration; Pleural Diseases; Respiratory Tract Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Muhammad Shoaib Nabi

  SIMS, Services Hospital, Lahore

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 22, 2025
• Study Start: April 1, 2023
• Primary Completion: March 31, 2025
• Study Completion: May 31, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

PA (1)