Pediatric Video Assisted Thoracoscopic Surgery (VATS) in Management of Empyema
NCT ID: NCT06424457
Last Updated: 2024-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
73 participants
INTERVENTIONAL
2024-04-01
2026-04-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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group A (VATS)
(group A) will receive VATS decortication as their definite management
video assisted thoracoscopy (VATS)
the investigators compare the outcomes of intervention by VATS and doing complete decortication or open surgery thoracotomy
group B (open thoracotomy)
(group B) will be assigned to open thoracotomy
open thoracotomy
the investigators assess the outcomes of intervention by doing complete decortication through open surgery thoracotomy
Interventions
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video assisted thoracoscopy (VATS)
the investigators compare the outcomes of intervention by VATS and doing complete decortication or open surgery thoracotomy
open thoracotomy
the investigators assess the outcomes of intervention by doing complete decortication through open surgery thoracotomy
Eligibility Criteria
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Inclusion Criteria
* Patients with empyema due to pneumonia.
* Patients with empyema had lasted for fewer than 3 weeks.
Exclusion Criteria
* 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.
1 Year
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Ali zein elabdein abd elaleim
Principal investigator
Principal Investigators
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Mohamed Ayyad, prof.
Role: STUDY_DIRECTOR
professor
Mahmoud sallam, MD
Role: STUDY_DIRECTOR
doctor
Locations
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Assiut University Hospital
Asyut, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Arnold DT, Hamilton FW, Morris TT, Suri T, Morley A, Frost V, Vipond IB, Medford AR, Payne RA, Muir P, Maskell NA. Epidemiology of pleural empyema in English hospitals and the impact of influenza. Eur Respir J. 2021 Jun 17;57(6):2003546. doi: 10.1183/13993003.03546-2020. Print 2021 Jun.
Krenke K, Urbankowska E, Urbankowski T, Lange J, Kulus M. Clinical characteristics of 323 children with parapneumonic pleural effusion and pleural empyema due to community acquired pneumonia. J Infect Chemother. 2016 May;22(5):292-7. doi: 10.1016/j.jiac.2016.01.016. Epub 2016 Feb 23.
Shojaee S, Lee HJ. Thoracoscopy: medical versus surgical-in the management of pleural diseases. J Thorac Dis. 2015 Dec;7(Suppl 4):S339-51. doi: 10.3978/j.issn.2072-1439.2015.11.66.
Bedawi EO, Hassan M, McCracken D, Rahman NM. Pleural infection: a closer look at the etiopathogenesis, microbiology and role of antibiotics. Expert Rev Respir Med. 2019 Apr;13(4):337-347. doi: 10.1080/17476348.2019.1578212. Epub 2019 Feb 20.
Other Identifiers
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04-2024-100227
Identifier Type: -
Identifier Source: org_study_id
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