Claudia Marhuenda1, Concepció Barceló2, Inmaculada Fuentes3, Gabriela Guillén2, Indalecio Cano4, María López4, Francisco Hernández5, Eduardo G Pérez-Yarza6, José A Matute7, María A García-Casillas7, Víctor Alvarez8, Antonio Moreno-Galdó9. 1. Departments of Pediatric Surgery, claudia.marhuenda@ssib.es. 2. Departments of Pediatric Surgery. 3. Clinical Pharmacology, and. 4. Department of Pediatric Surgery, Hospital 12 de Octubre, Madrid, Spain; 5. Department of Pediatric Surgery, Hospital La Paz, Madrid, Spain; 6. Department of Pediatrics, University of the Basque Country, UPV/EHU, San Sebastian, Spain; Division of Pediatric Respiratory Medicine, Hospital Universitario Donostia-Instituto Biodonostia, San Sebastián, España; Biomedical Research Centre Network for Respiratory Diseases (CIBERES), San Sebastián, Spain; 7. Department of Pediatric Surgery, Hospital Gregorio Marañón, Madrid, Spain; and. 8. Department of Pediatric Surgery, Hospital Central de Asturias, Oviedo, Spain. 9. Pediatric Pulmonology, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona. Barcelona, Spain;
Abstract
BACKGROUND AND OBJECTIVE: Parapneumonic empyema (PPE) is a frequent complication of acute bacterial pneumonia in children. There is limited evidence regarding the optimal treatment of this condition. The aim of this study was to compare the efficacy of drainage plus urokinase versus video-assisted thoracoscopic surgery in the treatment of PPE in childhood. METHODS: This prospective, randomized, multicenter clinical trial enrolled patients aged <15 years and hospitalized with septated PPE. Study patients were randomized to receive urokinase or thoracoscopy. The main outcome variable was the length of hospital stay after treatment. The secondary outcomes were total length of hospital stay, number of days with the chest drain, number of days with fever, and treatment failures. The trial was approved by the ethics committees of all the participating hospitals. RESULTS: A total of 103 patients were randomized to treatment and analyzed; 53 were treated with thoracoscopy and 50 with urokinase. There were no differences in demographic characteristics or in the main baseline characteristics between the 2 groups. No statistically significant differences were found between thoracoscopy and urokinase in the median postoperative stay (10 vs 9 days), median hospital stay (14 vs 13 days), or days febrile after treatment (4 vs 6 days). A second intervention was required in 15% of children in the thoracoscopy group versus 10% in the urokinase group (P = .47). CONCLUSIONS:Drainage plus urokinase instillation is as effective as video-assisted thoracoscopic surgery as first-line treatment of septated PPE in children.
RCT Entities:
BACKGROUND AND OBJECTIVE:Parapneumonic empyema (PPE) is a frequent complication of acute bacterial pneumonia in children. There is limited evidence regarding the optimal treatment of this condition. The aim of this study was to compare the efficacy of drainage plus urokinase versus video-assisted thoracoscopic surgery in the treatment of PPE in childhood. METHODS: This prospective, randomized, multicenter clinical trial enrolled patients aged <15 years and hospitalized with septated PPE. Study patients were randomized to receive urokinase or thoracoscopy. The main outcome variable was the length of hospital stay after treatment. The secondary outcomes were total length of hospital stay, number of days with the chest drain, number of days with fever, and treatment failures. The trial was approved by the ethics committees of all the participating hospitals. RESULTS: A total of 103 patients were randomized to treatment and analyzed; 53 were treated with thoracoscopy and 50 with urokinase. There were no differences in demographic characteristics or in the main baseline characteristics between the 2 groups. No statistically significant differences were found between thoracoscopy and urokinase in the median postoperative stay (10 vs 9 days), median hospital stay (14 vs 13 days), or days febrile after treatment (4 vs 6 days). A second intervention was required in 15% of children in the thoracoscopy group versus 10% in the urokinase group (P = .47). CONCLUSIONS:Drainage plus urokinase instillation is as effective as video-assisted thoracoscopic surgery as first-line treatment of septated PPE in children.
Authors: Morgan K Richards; Jarod P Mcateer; Todd C Edwards; Lucas R Hoffman; Matthew P Kronman; Dennis W Shaw; Adam B Goldin Journal: Surg Infect (Larchmt) Date: 2016-11-29 Impact factor: 2.150
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Authors: Michael H Livingston; Sanjay Mahant; Felix Ratjen; Bairbre L Connolly; Kevin Thorpe; Muhammad Mamdani; Ian Maclusky; Sophie Laberge; Lucy Giglia; J Mark Walton; Connie L Yang; Ashley Roberts; Anna C Shawyer; Mary Brindle; Simon J Parsons; Cristina A Stoian; Eyal Cohen Journal: Trials Date: 2017-06-24 Impact factor: 2.279
Authors: Florian J Segerer; Karin Seeger; Anna Maier; Christine Hagemann; Christoph Schoen; Mark van der Linden; Andrea Streng; Markus A Rose; Johannes G Liese Journal: Pediatr Pulmonol Date: 2016-09-20