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

NCT ID: NCT06424457

Last Updated: 2024-05-23

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-04-01

Brief Summary

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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

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

Conditions

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Thoracic Empyema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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group A (VATS)

(group A) will receive VATS decortication as their definite management

Group Type EXPERIMENTAL

video assisted thoracoscopy (VATS)

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

open thoracotomy

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

open thoracotomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ali zein elabdein abd elaleim

Principal investigator

Responsibility Role 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

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ali zein eladein, Ass.Lect.

Role: CONTACT

+201014566896

hussein Elkhayat, Assoc. Prof.

Role: CONTACT

+201005549653

Facility Contacts

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ali zein elabdein, MD

Role: primary

+201014566896

hussein Elkhayat, prof.

Role: backup

+201005549653

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.

Reference Type BACKGROUND
PMID: 33334937 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26919911 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26807282 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30707629 (View on PubMed)

Other Identifiers

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04-2024-100227

Identifier Type: -

Identifier Source: org_study_id

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