title: Multicenter prospective evaluation of a new articulating 5-mm endoscopic linear stapler.
abstract: BACKGROUND
  The objective of this study was to evaluate the safety and efficacy of a novel 5-mm laparoscopic linear stapler in clinical gastrointestinal surgical applications.
  
  
  METHODS
  A prospective, single-arm study with an open enrollment of subjects requiring stapling of the gastrointestinal (GI) tract was performed. The study endpoints were the number of complications and technical failures associated with the use of a novel stapler when compared to similar events with conventional staplers as described in the medical literature.
  
  
  RESULTS
  Seven centers enrolled 160 subjects, 150 of which were followed up to at least 30 days postoperatively. Intraoperative success: In 423 deployments, there were two staple line leaks and five staple line bleeds, all of which were intraoperatively resolved. In addition, incomplete staple lines were noted as a result of user error (n = 15) or device-related issues (n = 22), all of which were immediately resolved and none of which resulted in a complication or a change of the surgical procedure. Late outcomes: A total of 13 surgical complications in 160 patients were related to a GI transection or anastomosis, 12 of which related to a hand-sewn anastomosis or use of other commercially available staplers. One event (1/153, 0.065 %) on POD 1, involving bleeding of the staple line, was felt to be related to the use of the new stapler.
  
  
  CONCLUSIONS
  The study confirmed that the new device was user-friendly (9 % incidence of problems firing the device), reliable (3 % device failures) and safe (<1 % complication rate related to the stapler). Based on these results, it would seem that this new 5-mm stapler is a safe and effective alternative to standard 12-mm staplers.
authors.affiliation: DRK-Krankenhaus Clementinenhaus, Allgemein-, Viszeral- und Unfallchirurgie, Lützerodestr. 1, 30161, Hannover, Germany. akuthe@clementinenhaus.de.
authors.forename: Andreas
authors.initials: A
authors.lastname: Kuthe
authors.affiliation: Sana Klinikum Hameln-Pyrmont, Klinik für Allgemein- und Visceralchirurgie, Saint-Maur-Platz 1, 31785, Hameln, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Haemmerle
authors.affiliation: Klinikum Suedstadt Rostock, Klinik für Allgemein- und Visceralchirurgie, Sudring 81, 18059, Rostock, Germany.
authors.forename: Kaja
authors.initials: K
authors.lastname: Ludwig
authors.affiliation: Asklepios Klinik Barmbek, Allgemein-, Viszeralchirurgie, Rübenkamp 220, 22291, Hamburg, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Falck
authors.affiliation: Klinikum Lippe, Allgemein- und Viszeralchirurgie Detmold, Röntgenstraße 18, 32756, Detmold, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Hiller
authors.affiliation: DRK-Krankenhaus Clementinenhaus, Allgemein-, Viszeral- und Unfallchirurgie, Lützerodestr. 1, 30161, Hannover, Germany.
authors.forename: Frederick
authors.initials: F
authors.lastname: Mainik
authors.affiliation: DIAKO Ev. Diakonie-Krankenhaus, Klinik für Allgemein-und Visceralchirurgie, Gröpelinger Heerstraße 406 - 408, 28239, Bremen, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Freys
authors.affiliation: Henriettenstiftung Hannover, Klinik für Allgemein- und Visceralchirurgie, Marienstraße 72-90, 30171, Hannover, Germany.
authors.forename: Lev
authors.initials: L
authors.lastname: Dubovoy
authors.affiliation: Henriettenstiftung Hannover, Klinik für Allgemein- und Visceralchirurgie, Marienstraße 72-90, 30171, Hannover, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Jaehne
authors.affiliation: Asklepios Klinik Barmbek, Allgemein-, Viszeralchirurgie, Rübenkamp 220, 22291, Hamburg, Germany.
authors.forename: Karl
authors.initials: K
authors.lastname: Oldhafer
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D005767:Gastrointestinal Diseases / Q000601:surgery*; D041981:Gastrointestinal Tract / Q000601:surgery*; D006801:Humans; D010535:Laparoscopy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011446:Prospective Studies; D013528:Surgical Staplers; D017792:Surgical Stapling / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*
keywords: Anastomosis; Laparoscopic surgery; Laparoscopy; Staples; Surgical stapler