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.