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Clinical Trial NCT06424457 (VATS) for Thoracic Empyema is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Pediatric Video Assisted Thoracoscopic Surgery (VATS) in Management of Empyema 73 Pediatric

Recruiting
Clinical Trial NCT06424457 (VATS) is an interventional study for Thoracic Empyema that is recruiting. It started on April 1, 2024 with plans to enroll 73 participants. Led by Assiut University, it is expected to complete by April 1, 2026. The latest data from ClinicalTrials.gov was last updated on May 23, 2024.
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 s...

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Detailed Description
comparison between VATS decortication and open thoracotomy in cases of pediatric empyema
Official Title

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

Conditions
Thoracic Empyema
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • VATS
  • 04-2024-100227
NCT ID Number
NCT06424457
Start Date (Actual)
2024-04-01
Last Update Posted
2024-05-23
Completion Date (Estimated)
2026-04-01
Enrollment (Estimated)
73
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
pediatric empyema
VATS decortication
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimentalgroup 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
Experimentalgroup 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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
wound size
by centimeters
after 1week post operative
wound infection
which degree of infection or if there is a burst wound
during 1week post operative
hospital stay
by days post operative
1week post operative
air leak duration
by days and takes how many days to stop air leakage
during 1week post operative
pain score
through pain score scale 0 No Pain 1-3 Mild Pain (nagging, annoying) 4-6 Moderate Pain 7-10 Severe Pain (disabling)
during 1week post operative.
Early mobilization.
how many days
during 1week post operative
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
chronic pain
presented or not
after 1month post operative
avoidance of scoliosis
which degree
after 1month post operative
shoulder muscle girdle weakness and deformity.
yes or no
after 1month post operative
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult
Minimum Age
1 Year
Eligible Sexes
All
  • pediatric patients 1 yrs. : ≤ 18 yrs.
  • Patients with empyema due to pneumonia.
  • Patients with empyema had lasted for fewer than 3 weeks.

  • 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.
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Study Responsible Party
Ali zein elabdein abd elaleim, Principal Investigator, Principal investigator, Assiut University
Study Central Contact
Contact: ali zein eladein, Ass.Lect., +201014566896, [email protected]
Contact: hussein Elkhayat, Assoc. Prof., +201005549653, [email protected]
1 Study Locations in 1 Countries
Assiut University Hospital, Asyut, +2088, Egypt
ali zein elabdein, MD, Contact, +201014566896, [email protected]
hussein Elkhayat, prof., Contact, +201005549653, [email protected]
Recruiting