The Role of Decortication in Complex Empyema Cases: Multidrug Resistance and Tuberculosis at the Forefront

NCT07167823 | Completed DMC

• 1 other identifier: IRB/2025/1546/SIMS
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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. This study aims to report a detailed microbiological profile of patients operated for empyema thoracis and also correlate it with perioperative clinical outcomes. Patients who underwent surgery for empyema thoracis between January 2022 to June 2025 were included in the study. This study was carried out at two centers; Thoracic Surgery Department, Services Hospital Lahore. Patients were taken up for surgery after thorough preoperative evaluation. Perioperative outcomes were correlated with the results of microbiological analysis to evaluate their effect on clinical outcomes. This study highlights the emergence of Gram-negative organisms in bacterial empyema and emergence of multidrug resistance in tubercular empyema. Clinical outcome correlation revealed increased complications in culture-positive cases in both tubercular and nontubercular empyemas

Conditions

Pleural Empyema; Tuberculosis (TB); Bacterial Sepsis

Keywords

Multi-drug resistance; Decortication; Bacterial empyema thoracis; tuberculous empyema thoracis

Outcome Measures

Primary Outcomes (1)

• expansion of lung

  After decortication, complete re-expansion is defined as ≥90% of the ipsilateral hemithorax occupied by aerated lung on standardized postero-anterior chest radiograph, assessed at full inspiration. Results will be reported as the proportion of participants meeting the ≥90% threshold and units of measurement is percent of hemithorax.

  post-operative day 03 and day 30.

Secondary Outcomes (1)

• Post-operative pain

  post-operative day 01, day 3, day 07 and day 30

Study Arms (2)

Bacterial empyema thoracis

all participants that were diagnosed as having empyema thoracis due to bacterial organisms, also included multi-drug resistant organisms.

Procedure: Decortication

Tuberculous Empyema Thoracis

all participants that were diagnosed as having empyema thoracis due to mycobacterium tuberculosis, also included multi-drug resistant organisms.

Procedure: Decortication

Interventions

Decortication PROCEDURE

removal of fibrinous infected material from pleural cavity and thick fibrous entrapping peel over the lung resulting in full expansion of lung.

Bacterial empyema thoracis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with pleural empyema (MDR bacterial and tuberculous) who underwent surgical decortication (VATS or open thoracotomy) and admitted in thoracic surgery unit of Services hospital Lahore.

You may qualify if:

• Patients diagnosed with pleural empyema based on clinical, radiological, and microbiological confirmation.
• Patients who underwent surgical decortication for complicated or refractory empyema.

You may not qualify if:

• Patients with non-infectious pleural effusions (e.g., malignant pleural effusion, hemothorax, or chylothorax).
• Empyema cases resolved with medical management alone (antibiotics and/or chest tube drainage) without requiring surgical intervention.
• Patients with severe systemic conditions (e.g., end-stage organ failure, terminal malignancy) where empyema management was not the primary therapeutic focus.

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

Study Sites (1)

Services Institute of Medical Sciences (SIMS), Services Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Empyema, Pleural; Tuberculosis

Interventions

Cerebral Decortication

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Empyema; Suppuration; Pleural Diseases; Respiratory Tract Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Muhammad Shoaib Nabi, Professor of Thoracic Surgery

  Services Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 11, 2025
• Study Start: January 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

PA (1)