Feasibility and Safety of ArtiSential for Minimally Invasive Surgery in Early-stage Gynecologic Cancer: Results from the KGOG 4002/GYANT Study.

Abstract

Objectives: The objective is to evaluate the feasibility and safety of ArtiSential for performing minimally invasive surgeries for gynecological cancers.

Materials and methods: We conducted a prospective observational study at 10 Tertiary Institutional Hospitals in Korea between November 2021 and April 2022. Eligible patients were 18 years or older and planned to undergo minimally invasive surgery for gynecologic cancer. We collected baseline characteristics, surgical information, and postoperative outcomes. The primary endpoint was to compare the operation time required for gynecologic cancer surgery using ArtiSential with the reported operation time for surgery using conventional laparoscopic instruments or robots. The secondary endpoints were to evaluate the surgical outcomes of gynecologic cancer surgery using ArtiSential compared to conventional laparoscopic instruments or robots and collect operator feedback on equipment improvements during surgery.

Results: Forty patients were enrolled in this study, including 19 with endometrial cancer, 15 with cervical cancer, and 6 with ovarian cancer. The average operation time was 187.0 ± 49.2 min, with no complications encountered during surgery. Pelvic lymph nodes were assessed in 34 patients, with the ArtiSential device utilized in 22 (64.7%) of these patients, at an average assessment time of 40.3 ± 19.4 min. Most surgeons using the ArtiSential device reported that it performed slightly better than conventional laparoscopic instruments.

Conclusion: The use of the ArtiSential device in minimally invasive surgery has been demonstrated to be both feasible and safe for the treatment of early-stage gynecologic cancer.