title: A novel flexible endoluminal stapling device for use in NOTES colotomy closure: a feasibility study using an ex vivo porcine model.
abstract: BACKGROUND
  With advances in endoscopic diagnosis of early-stage gastrointestinal pathology, the need to offer minimally invasive treatment is attracting significant interest. It is essential that secure and consistent closure of full-thickness colonic resections and colotomy access be provided in natural orifice translumenal surgery (NOTES). This ex vivo porcine study aimed to evaluate a novel prototype flexible endoscopic stapler device for use in closure of full-thickness colonic defects.
  
  
  METHODS
  A feasibility study using ex vivo porcine colon was undertaken to explore the potential of the prototype stapler to close and seal a colotomy. A standardized linear colotomy was created in 30 colons. The novel flexible endostapler was used to close 20, interrupted hand-sewn sutures to close 5, and a well-validated linear stapler to close 5 of these colotomies. The colons were subsequently subjected to leak pressure testing.
  
  
  RESULTS
  The colotomy closure using the prototype stapler endoluminally required a median time of 280 s. No statistically significant difference in leak pressures between the stapler and the other techniques was described. Although the endostapler without any colotomy was found to have the highest median leak pressures and the interrupted sutures the lowest pressures, no significant difference could be demonstrated (p = 0.52). Furthermore, no significant difference was demonstrated when the closure integrity created by the flexible stapler was compared with that created by the well-validated linear stapler.
  
  
  CONCLUSIONS
  The results suggest that the flexible endoscopic stapler is an effective device for the safe closure of a visceral defect, which in this feasibility study was equivalent to other well-established techniques. Further studies will focus on in vivo application of the prototype stapling device in the setting of full-thickness colonic resection.
authors.affiliation: Department of Biosurgery and Surgical Technology, St. Mary's Hospital, Imperial College, London, UK. m.sodergren@imperial.ac.uk
authors.forename: Mikael
authors.initials: M
authors.lastname: Sodergren
authors.forename: James
authors.initials: J
authors.lastname: Clark
authors.forename: John
authors.initials: J
authors.lastname: Beardsley
authors.forename: Ted
authors.initials: T
authors.lastname: Bryant
authors.forename: Kenneth
authors.initials: K
authors.lastname: Horton
authors.forename: Ara
authors.initials: A
authors.lastname: Darzi
authors.forename: Julian
authors.initials: J
authors.lastname: Teare
mesh_terms: D000818:Animals; D003106:Colon / Q000601:surgery*; D005240:Feasibility Studies; D066298:In Vitro Techniques; D023421:Models, Animal; D057605:Natural Orifice Endoscopic Surgery / Q000295:instrumentation*; D018709:Statistics, Nonparametric; D013528:Surgical Staplers; D013552:Swine