title: Infection during natural orifice transluminal endoscopic surgery: a randomized, controlled study in a live porcine model.
abstract: BACKGROUND
  Currently reported natural orifice transluminal endoscopic surgery (NOTES) procedures in animals have been done in heterogeneous milieus ranging from nonsterile to sterile procedures, with mixed results, including no infection in those performed in nonsterile settings.
  
  
  OBJECTIVE
  To establish the potential frequency of infection during NOTES, comparing sterile to nonsterile approaches.
  
  
  METHODS
  Survival experiments on sixteen 50-kg pigs.
  
  
  METHODS
  From pilot data (100% infection frequency after nonsterile procedures), sample size (8 animals in each group) was calculated by using a power of 95% and an alpha risk of 0.05. The animals were randomly assigned to two groups: In the transgastric peritoneoscopy study group, liver and ovarian biopsies were performed with sterile overtubes, endoscopes, and accessories and the use of preoperative intravenous antibiotics and antiseptic gastric lavage. In the nonsterile (control) group, the same procedures were performed with nonsterile endoscopes and accessories without the use of gastric lavage and preoperative antibiotics. Complete transmural closure of the transgastric access site was made in all animals. After a 1-week survival time, all animals were killed for necropsy, which included Gram staining and peritoneal cultures.
  
  
  METHODS
  Intraperitoneal infection on necropsy.
  
  
  RESULTS
  All necropsies revealed intraperitoneal infection (abscesses, fibrinopurulent exudates, and adhesions) in the control group (frequency of infection 100%). Peritoneal bacterial culture grew various aerobic and anaerobic organisms. No gross or bacteriological evidence of infection was seen in the sterile group (frequency of infection 0%, P value = <.0002).
  
  
  CONCLUSIONS
  Animal experiments.
  
  
  CONCLUSIONS
  Nonsterile conditions invariably lead to intraperitoneal infection. Aseptic techniques during NOTES can prevent intra-abdominal infection. Future studies will determine which infection prevention steps are mandatory and which can be omitted during NOTES procedures.
authors.affiliation: Division of Gastroenterology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
authors.forename: Samuel A
authors.initials: SA
authors.lastname: Giday
authors.forename: Xavier
authors.initials: X
authors.lastname: Dray
authors.forename: Priscilla
authors.initials: P
authors.lastname: Magno
authors.forename: Jonathan M
authors.initials: JM
authors.lastname: Buscaglia
authors.forename: Eun Ji
authors.initials: EJ
authors.lastname: Shin
authors.forename: Vihar C
authors.initials: VC
authors.lastname: Surti
authors.forename: Lia
authors.initials: L
authors.lastname: Assumpcao
authors.forename: Michael R
authors.initials: MR
authors.lastname: Marohn
authors.forename: Dawn
authors.initials: D
authors.lastname: Ruben
authors.forename: Andrew
authors.initials: A
authors.lastname: Zhigalin
authors.forename: Laurie J
authors.initials: LJ
authors.lastname: Pipitone
authors.forename: Sergey V
authors.initials: SV
authors.lastname: Kantsevoy
mesh_terms: D000818:Animals; D001207:Asepsis / Q000379:methods*; D001706:Biopsy; D005260:Female; D010535:Laparoscopy / Q000379:methods*; D008099:Liver / Q000473:pathology; D010053:Ovary / Q000473:pathology; D010538:Peritonitis / Q000209:etiology* / Q000473:pathology; D013530:Surgical Wound Infection / Q000209:etiology* / Q000473:pathology; D013552:Swine