title: A prospective, randomized assessment of a spatial orientation device in natural orifice transluminal endoscopic surgery.
abstract: BACKGROUND
  One of the challenges in natural orifice transluminal endoscopic surgery (NOTES) is spatial orientation. The Queen's NOTES group has devised a novel method of orientation by using a magnetic device that passes within an endoscope channel allowing for 3-dimensional imaging of the shape and orientation of the endoscope.
  
  
  OBJECTIVE
  To assess the feasibility and utility of a novel orientation device.
  
  
  METHODS
  Randomized, controlled trial.
  
  
  METHODS
  Animal research laboratory study on four 25-kg pigs.
  
  
  METHODS
  The device was tested by 6 endoscopists and 6 laparoscopic surgeons. Starting at the gastrotomy, the time to identify 4 targets was recorded. Participants were required to identify and touch the gallbladder, the fallopian tube, a clip on the abdominal wall, and the liver edge. Use of the orientation device was randomized for each session.
  
  
  METHODS
  Time to identify targets with and without the device. Secondary analysis assessed differences between medical specialties and level of training.
  
  
  RESULTS
  The mean time to identify all 4 targets with the device was 75.08 ± 42.68 seconds versus 100.20 ± 60.70 seconds without the device (P <.001). The mean time to identify all 4 targets on the first attempt was 102.29 ± 61.36 seconds versus 72.99 ± 40.19 seconds on the second attempt (P <.001). No differences based on specialty or level of training were identified.
  
  
  CONCLUSIONS
  Small sample size and simplicity of tasks.
  
  
  CONCLUSIONS
  Regardless of randomization order, both groups were faster with the device. These encouraging results warrant further study using more complex scenarios.
authors.affiliation: Gastrointestinal Diseases Research Unit, Queen’s University, Kingston, Ontario, Canada.
authors.forename: Sharyle
authors.initials: S
authors.lastname: Fowler
authors.forename: Mohamed S
authors.initials: MS
authors.lastname: Hefny
authors.forename: Elvis C S
authors.initials: EC
authors.lastname: Chen
authors.forename: Randy E
authors.initials: RE
authors.lastname: Ellis
authors.forename: Dale
authors.initials: D
authors.lastname: Mercer
authors.forename: Diederick
authors.initials: D
authors.lastname: Jalink
authors.forename: Andrew
authors.initials: A
authors.lastname: Samis
authors.forename: Lawrence C
authors.initials: LC
authors.lastname: Hookey
mesh_terms: D000818:Animals; D019723:Endoscopes; D005260:Female; D005762:Gastroenterology; D006801:Humans; D057605:Natural Orifice Endoscopic Surgery / Q000295:instrumentation* / Q000379:methods*; D011446:Prospective Studies; D011897:Random Allocation; D013028:Space Perception; D013270:Stomach / Q000601:surgery; D013552:Swine; D013996:Time and Motion Studies