Design: To evaluate the tool's practical applicability in a surgical context, we have conducted a Randomized Controlled Trial study involving preoperative planning and intraoperative guidance of laparoscopic and robotic myomectomy procedures for 18 patients.

Setting: Academic Hospital

Patients or Participants: Patients with 3 or more uterine myomas were selected within 6 months of their surgery date. The study participants were randomly assigned into two groups of 9 (control group) and 9 (test group).

Interventions: The control group received standard pre-operative planning based on 2D MRI imaging, while the test group were assigned to undergo enhanced preoperative planning and an intraoperative procedure with our smart 3D MRI visualization tool.

Measurements and Main Results: We measured the procedure time, the blood loss, and rate of repeat operations. The mean operating time for the control group was 221.8 (± 48.3) minutes vs. 222.7(± 45.8) minutes for the intervention group. The blood loss was 343.7(± 233) vs. 506.2(± 267.8) mL for control and intervention group, respectively. None of these variables showed any significant difference. However, three of the patients in the control group had to return for a second procedure vs none for the intervention group. In surgeon survey results, all agree that the SmartHER 3D visualization provides a clearer understanding of patient anatomy, number, precise location and spatial relationship of fibroids.

Conclusion: Our pilot study did not indicate significant reductions in EBL or surgery time, likely due to confounding factors and sample size, however it revealed a decrease in the need for repeat operations. Most of these were due to either missed myomas or misinterpretations of myoma locations. SmartHer 3D visualization could help avoid cases by providing a better holistic visualization of the fibroids and anatomies.