title: Endolumenal colon occlusion device for transanal and transrectal surgery--a porcine feasibility study.
abstract: OBJECTIVE
  Although several studies have demonstrated the feasibility of transrectal natural orifice translumenal endoscopic surgery (NOTES), its clinical application has been hindered by concerns regarding potential infectious complications. The aim of this study was to evaluate the feasibility of a newly developed device for endolumenal colon occlusion (ColoShield) in an acute porcine model.
  
  
  METHODS
  The principle of the ColoShield device is based on two balloons, with negative pressure in between. The ColoShield device and a gauze tamponade as a control group were evaluated in a non-survival study on 16 pigs. The efficacy of the occlusion system in establishing a leak-proof pneumorectum and in sealing the colon from proximal (watertight sealing) was tested by a standardized study course. Finally, the colon/rectum was explanted for macroscopic and microscopic examination.
  
  
  RESULTS
  A 20-mmHg leak-proof pneumorectum over a period of 10 min could be achieved in seven of eight (87 %) animals with the ColoShield device and in none of eight (0 %) animals with gauze tamponade (p < 0.001). In the watertight sealing test, mean intracolonic pressures of 23.5 ± 18.1 (0-53) mmHg using the ColoShield device and 0 ± 1.1 (0-3) mmHg using gauze tamponade (p = 0.003) were documented proximal to the occlusion system before a leakage occurred. Macroscopic and histopathological examinations revealed no significant impairment of the colon specimen in either group.
  
  
  CONCLUSIONS
  ColoShield proved to be a safe and effective device for a reversible endolumenal colon occlusion. Further studies should evaluate its impact on procedural sterility during transrectal NOTES.
authors.affiliation: Department of General, Visceral and Transplant Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany. georg.linke@med.uni-heidelberg.de
authors.forename: Georg R
authors.initials: GR
authors.lastname: Linke
authors.forename: Benedict
authors.initials: B
authors.lastname: Carstensen
authors.forename: Georg
authors.initials: G
authors.lastname: Kähler
authors.forename: Andreas
authors.initials: A
authors.lastname: Zerz
authors.forename: Maxym
authors.initials: M
authors.lastname: Shevchenko
authors.forename: Rene
authors.initials: R
authors.lastname: Warschkow
authors.forename: Felix
authors.initials: F
authors.lastname: Lasitschka
authors.forename: Hannes G
authors.initials: HG
authors.lastname: Kenngott
authors.forename: Jonas
authors.initials: J
authors.lastname: Senft
authors.forename: Beat P
authors.initials: BP
authors.lastname: Müller-Stich
mesh_terms: D000818:Animals; D021721:Balloon Occlusion / Q000295:instrumentation*; D003106:Colon / Q000473:pathology / Q000601:surgery*; D004867:Equipment Design; D004869:Equipment Safety; D005240:Feasibility Studies; D057605:Natural Orifice Endoscopic Surgery / Q000295:instrumentation*; D012007:Rectum / Q000473:pathology / Q000601:surgery*; D013530:Surgical Wound Infection / Q000517:prevention & control*; D013552:Swine