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Management of Empyema in Children: A comparison of early and late Video-assisted Thoracoscopic Surgery (VATS) .


- candidate number13464
- NTR NumberNTR3673
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-okt-2012
- Secondary IDs2012/247 MEC UZ Brussel
- Public TitleManagement of Empyema in Children: A comparison of early and late Video-assisted Thoracoscopic Surgery (VATS) .
- Scientific TitleManagement of Empyema in Children: A comparison of early and late Video-assisted Thoracoscopic Surgery (VATS).
- ACRONYMVATS study
- hypothesisIt has been demonstrated that VATS is a good alternative treatment option for chest drainage in children with parapneumonic effusion. Clinical improvement even seems to occur faster after VATS, indicating that when VATS is performed in an early stage it might fasten clinical improvement.
In this prospective study we want to compare the clinical outcomes after early versus late VATS.
- Healt Condition(s) or Problem(s) studiedPneumonia, Empyema, Video-assisted Thoracoscopic Surgery (VATS), Parapneumonic effusion
- Inclusion criteriaChildren (6 months -15 years) with community-acquired pneumonia and parapneumonic effusion.
- Exclusion criteria1. Children aged < 6 months;
2. Trauma, thoracotomy, chronic lung disease (Cystic Fibrosis or Primary Ciliary Dyskinesia).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2012
- planned closingdate1-sep-2014
- Target number of participants50
- InterventionsEvery child with pneumonia and parapneumonic effusion will be hospitalized and treated according to hospital protocol. If there is no clinical improvement 48 hours after starting intravenous antibiotics or insertion of chest drain, CT will be done, and, if needed, VATS will be performed.
- Primary outcomeMorbidity.
- Secondary outcome1. Time to removal of drains;
2. Duration of antibiotics;
3. Duration of stay in the hospital.
- Timepoints1. Hospitalization;
2. Follow-up after 1 month;
3. Follow-up after 3 months if no complete recovery after 1 month.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. J. Willekens
- CONTACT for SCIENTIFIC QUERIESMD. J. Willekens
- Sponsor/Initiator Universitair Ziekenhuis Brussel
- Funding
(Source(s) of Monetary or Material Support)
Universitair Ziekenhuis Brussel
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD22-okt-2012 - 12-nov-2012


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