Pediatric Video Assisted Thoracoscopic Surgery (VATS) in Management of Empyema

Not Applicable

Recruiting

• Conditions: Thoracic Empyema
• Interventions: Procedure: video assisted thoracoscopy (VATS); Procedure: open thoracotomy

• Registration Number: NCT06424457
• Lead Sponsor: Assiut University

Brief Summary

Thoracic surgeons have developed a thoracoscopic procedure which is less intrusive method allows complete evacuation and washing of the debris from the pleural cavity. This approach may also have the benefit of less invasive maneuver, a shorter hospital stay and a decreased rate of postoperative complications.

The aim of this study is to evaluate the advantages and disadvantages of the video-assisted thoracoscopic surgery (VATS) approach in comparison with thoracotomy in management of empyema in pediatric patients.

Detailed Description

comparison between VATS decortication and open thoracotomy in cases of pediatric empyema

Study Timeline

• Study Start: 2024-04-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Study First Posted: 2024-05-22
• Last Update Posted: 2024-05-23
• Primary Completion: 2025-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• pediatric patients 1 yrs. : ≤ 18 yrs.
• Patients with empyema due to pneumonia.
• Patients with empyema had lasted for fewer than 3 weeks.

Exclusion Criteria

• Patients < 1 yrs. old.
• Patients with whom pleural empyema had lasted for more than 3 weeks.
• Patients with empyema had been caused by trauma.
• Patients whose parents refuse to be included in the study.
• Patients with empyema due to ruptured lung abscess.
• Patients with empyema due to chest wall abscess.
• Patients with empyema due to rib osteomyelitis.
• Patients with bronchopleural fistula.
• Patients with post-surgical empyema.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
group A (VATS)	video assisted thoracoscopy (VATS)	(group A) will receive VATS decortication as their definite management
group B (open thoracotomy)	open thoracotomy	(group B) will be assigned to open thoracotomy

Primary Outcome Measures

Name	Time	Method
wound size	after 1week post operative	by centimeters
wound infection	during 1week post operative	which degree of infection or if there is a burst wound
air leak duration	during 1week post operative	by days and takes how many days to stop air leakage
Early mobilization.	during 1week post operative	how many days
hospital stay	1week post operative	by days post operative
pain score	during 1week post operative.	through pain score scale 0 No Pain 1-3 Mild Pain (nagging, annoying) 4-6 Moderate Pain 7-10 Severe Pain (disabling)

Secondary Outcome Measures

Name	Time	Method
chronic pain	after 1month post operative	presented or not
avoidance of scoliosis	after 1month post operative	which degree
shoulder muscle girdle weakness and deformity.	after 1month post operative	yes or no

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt