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keyhole surgery for pus in chest versus chemical clearance of pus in the chest children

Prospective analysis to compare the outcome of primary surgery vs fibrinolytics in children with empyema Thoracis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012403
Enrollment
46
Registered
2018-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Children suffering from empyema thoracic Health Condition 2: J90- Pleural effusion, not elsewhere classified

Interventions

Intervention1: Video assisted Thoracoscopic Surgery for Empyema: This is the standard of care for children with stage II empyema in children Control Intervention1: Urokinase: This will be instilled th

Sponsors

Centre for advance Research Rajiv Gandhi University of Health Sciences Karnataka
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Diagnosis of Empyema with pleural fluid showing a)Frank pus appearance or b)organisms in grams stain and 2.Evidence of septations or loculations and pleural thickening on chest X-ray and Ultrasound thorax.

Exclusion criteria

Exclusion criteria: 1.Resolution of Empyema with initial intercostal drainage 2.Previous history of hypersensitivity to fibrinolytics 3.Complicated pneumonia (Organized empyema with thick peel, lung abscess, Necrotizing pneumonia, Bronchopleural fistula) 4.Bleeding diathesis 5.Immunocompromized status 6.Associated major co-morbid condition/s as determined by clinician 7.Air leak after ICD insertion

Design outcomes

Primary

MeasureTime frame
Success rate of each therapy Treatment efficacy of each arm of study in terms of duration for clinical recovery, ICD days, analgesia requirement, and intensive care requirements. Cost analysis Length of hospital stay Timepoint: Immediate post therapy 30 days 6 months

Secondary

MeasureTime frame
Microbiology of pleural fluid- yield and incidence of organisms Long term complications Determination of criteria for CT scan Antibiotic guidelines to institute for management of empyema Primary role of chest tube drainage only for empyema management. Need for blood transfusion Timepoint: 30 days

Countries

India

Contacts

Public ContactDr Gowri Shankar

Indira Gandhi Institute of Child Health Bangalore

bcgshankar@gmail.com9845804491

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026