|- candidate number||13464|
|- NTR Number||NTR3673|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-okt-2012|
|- Secondary IDs||2012/247 MEC UZ Brussel|
|- Public Title||Management of Empyema in Children: A comparison of early and late Video-assisted Thoracoscopic Surgery (VATS) .|
|- Scientific Title||Management of Empyema in Children: A comparison of early and late Video-assisted Thoracoscopic Surgery (VATS).|
|- ACRONYM||VATS study|
|- hypothesis||It 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) studied||Pneumonia, Empyema, Video-assisted Thoracoscopic Surgery (VATS), Parapneumonic effusion|
|- Inclusion criteria||Children (6 months -15 years) with community-acquired pneumonia and parapneumonic effusion.|
|- Exclusion criteria||1. Children aged < 6 months;|
2. Trauma, thoracotomy, chronic lung disease (Cystic Fibrosis or Primary Ciliary Dyskinesia).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-okt-2012|
|- planned closingdate||1-sep-2014|
|- Target number of participants||50|
|- Interventions||Every 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 outcome||Morbidity.
|- Secondary outcome||1. Time to removal of drains;|
2. Duration of antibiotics;
3. Duration of stay in the hospital.
|- Timepoints||1. Hospitalization;|
2. Follow-up after 1 month;
3. Follow-up after 3 months if no complete recovery after 1 month.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. J. Willekens|
|- CONTACT for SCIENTIFIC QUERIES||MD. J. Willekens|
|- Sponsor/Initiator ||Universitair Ziekenhuis Brussel|
(Source(s) of Monetary or Material Support)
|Universitair Ziekenhuis Brussel|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||22-okt-2012 - 12-nov-2012|