title: Adverse events of NOTES mediastinoscopy compared to conventional video-assisted mediastinoscopy: a randomized survival study in a porcine model.
abstract: BACKGROUND
  Safety is a concern in natural orifice transluminal endoscopic surgery (NOTES) mediastinoscopy. The objective of this study was to compare the safety of NOTES mediastinoscopy with video-assisted mediastinoscopy (VAM).
  
  
  METHODS
  Twenty-four pigs were randomly assigned to NOTES or VAM. Thirty-minute mediastinoscopies were performed with the identification of seven predetermined structures. The animals were euthanized after 7 days and necropsy was performed.
  
  
  RESULTS
  Mediastinoscopy was not possible in one animal in each group. There were more intraoperative adverse events with NOTES than VAM (7 vs. 2, P = 0.04); hemorrhage was the most frequent adverse event (4 and 1, respectively). At necropsy, pathological findings were observed in 13 animals (9 NOTES and 4 VAM; P = 0.03). Inflammatory parameters were not different between groups and were not related to adverse events.
  
  
  CONCLUSIONS
  Systematic NOTES mediastinoscopy is possible and comparable to VAM in terms of number of organs identified and inflammatory impact. However, the safety profile of NOTES mediastinoscopy has to be improved before it can be adopted in a clinical setting.
authors.affiliation: Department of Gastroenterology, Hospital Clínic, University of Barcelona, Barcelona, Spain.
authors.forename: Henry
authors.initials: H
authors.lastname: Córdova
authors.affiliation: Anesthesiology Department, Hospital Clínic, University of Barcelona, Barcelona, Spain.
authors.forename: Georgina
authors.initials: G
authors.lastname: Cubas
authors.affiliation: Department of Thoracic Surgery, Hospital Clínic, University of Barcelona, Barcelona, Spain.
authors.forename: Marc
authors.initials: M
authors.lastname: Boada
authors.affiliation: Department of Gastroenterology, Hospital Clínic, University of Barcelona, Barcelona, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Rodríguez de Miguel
authors.affiliation: Anesthesiology Department, Hospital Clínic, University of Barcelona, Barcelona, Spain.
authors.forename: Graciela
authors.initials: G
authors.lastname: Martínez-Pallí
authors.affiliation: Department of Thoracic Surgery, Hospital Clínic, University of Barcelona, Barcelona, Spain.
authors.forename: Josep M
authors.initials: JM
authors.lastname: Gimferrer
authors.affiliation: Department of Gastroenterology, Hospital Clínic, University of Barcelona, Barcelona, Spain.
authors.forename: Gloria
authors.initials: G
authors.lastname: Fernández-Esparrach