A prospective, randomized assessment of a spatial orientation device in natural orifice transluminal endoscopic surgery.

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.

DESIGN

Randomized, controlled trial.

SETTING

Animal research laboratory study on four 25-kg pigs.

INTERVENTION: 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.

MAIN OUTCOME MEASUREMENTS: 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.

LIMITATIONS: Small sample size and simplicity of tasks.

CONCLUSION

Regardless of randomization order, both groups were faster with the device. These encouraging results warrant further study using more complex scenarios.