Clinical trial NCT06424457: Pediatric Video Assisted Thoracoscopic Surgery (VATS) in Management of Empyema
Official title: Video Assisted Thoracoscopic Surgery (VATS) Versus Thoracotomy in Management of Empyema in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracic Empyema
Keywords: pediatric empyema
VATS decortication
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 73
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: wound size
timeFrame: after 1week post operative
measure: wound infection
timeFrame: during 1week post operative
measure: hospital stay
timeFrame: 1week post operative
measure: air leak duration
timeFrame: during 1week post operative
measure: pain score
timeFrame: during 1week post operative.
measure: Early mobilization.
timeFrame: during 1week post operative
Secondary outcomes:
measure: chronic pain
timeFrame: after 1month post operative
measure: avoidance of scoliosis
timeFrame: after 1month post operative
measure: shoulder muscle girdle weakness and deformity.
timeFrame: after 1month post operative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: professor
name: Mohamed Ayyad, prof.
role: STUDY_DIRECTOR
affiliation: doctor
name: Mahmoud sallam, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.