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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06424457
Acronym
VATS
Enrollment
73
Registered
2024-05-22
Start date
2024-04-01
Completion date
2026-04-01
Last updated
2024-05-23

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

Conditions

Thoracic Empyema

Keywords

pediatric empyema, VATS decortication

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

Interventions

the investigators compare the outcomes of intervention by VATS and doing complete decortication or open surgery thoracotomy

PROCEDUREopen thoracotomy

the investigators assess the outcomes of intervention by doing complete decortication through open surgery thoracotomy

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Early mobilization.during 1week post operativehow many days
hospital stay1week post operativeby days post operative
air leak durationduring 1week post operativeby days and takes how many days to stop air leakage
pain scoreduring 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)
wound sizeafter 1week post operativeby centimeters
wound infectionduring 1week post operativewhich degree of infection or if there is a burst wound

Secondary

MeasureTime frameDescription
avoidance of scoliosisafter 1month post operativewhich degree
shoulder muscle girdle weakness and deformity.after 1month post operativeyes or no
chronic painafter 1month post operativepresented or not

Countries

Egypt

Contacts

Primary Contactali zein eladein, Ass.Lect.
ali_zein@aun.edu.eg+201014566896
Backup Contacthussein Elkhayat, Assoc. Prof.
elkhayat@aun.edu.eg+201005549653

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026