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RecruitingNCT06424457VATSUpdated May 23, 2024

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

An interventional study of video assisted thoracoscopy (VATS) and open thoracotomy in Thoracic Empyema, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2024-05-23.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Randomized
Ages
1 Year to 18 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Thoracic Empyema

Browse trials for

Keywords

  • pediatric empyema
  • VATS decortication
03

In context

Empyema, Pleural

33 studies on the registry are indexed under Empyema, Pleural; 11 are open to participants now.

This study's planned enrollment of 73 is close to the median of 77 across 26 interventional studies indexed under Empyema, Pleural.

Browse Empyema, Pleural studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Care provider)
Enrollment
73 participants (estimated)

Study arms

  • Experimental
    group A (VATS)

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

    Procedure: video assisted thoracoscopy (VATS)

  • Experimental
    group B (open thoracotomy)

    (group B) will be assigned to open thoracotomy

    Procedure: open thoracotomy

Interventions

  • Procedurevideo assisted thoracoscopy (VATS)

    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

06

What researchers measure

Primary outcomes

  1. wound size

    by centimeters

    Time frame: after 1week post operative

  2. wound infection

    which degree of infection or if there is a burst wound

    Time frame: during 1week post operative

  3. hospital stay

    by days post operative

    Time frame: 1week post operative

  4. air leak duration

    by days and takes how many days to stop air leakage

    Time frame: during 1week post operative

  5. pain score

    through pain score scale 0 No Pain 1-3 Mild Pain (nagging, annoying) 4-6 Moderate Pain 7-10 Severe Pain (disabling)

    Time frame: during 1week post operative.

  6. Early mobilization.

    how many days

    Time frame: during 1week post operative

Secondary outcomes

  1. chronic pain

    presented or not

    Time frame: after 1month post operative

  2. avoidance of scoliosis

    which degree

    Time frame: after 1month post operative

  3. shoulder muscle girdle weakness and deformity.

    yes or no

    Time frame: after 1month post operative

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 33334937 ↗
  • 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. PubMed 26919911 ↗
  • 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. PubMed 26807282 ↗
  • 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. PubMed 30707629 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2024 (actual). Primary completion is estimated for Apr 2025, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 17, 2024
First posted
May 22, 2024
StartActual
Apr 1, 2024
Primary completionEst.
Apr 1, 2025
CompletionEst.
Apr 1, 2026
Last update
May 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06424457
Lead sponsor
Assiut University
Responsible party
Ali zein elabdein abd elaleim (Principal investigator, Assiut University) — Principal investigator
First posted
May 22, 2024
Start date
Apr 1, 2024
Primary completion
Apr 1, 2025 (estimated)
Completion
Apr 1, 2026 (estimated)
Last update
May 23, 2024

Study contacts

ali zein eladein, Ass.Lect.
Contact
ali_zein@aun.edu.eg
+201014566896
hussein Elkhayat, Assoc. Prof.
Contact
elkhayat@aun.edu.eg
+201005549653
Mohamed Ayyad, prof.
study director · professor
Mahmoud sallam, MD
study director · doctor

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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