Kang Ok-Ju, Kim Kidong, Lee Keun Ho, Kim Min Kyu, Hwang Jong Ha, Kim Taehun, Lee Nak Woo, Chun Kyoung Chul, Seong Seok Ju, Kim Tae-Joong, Oh Dasol, Park Jeong-Yeol
Department of Obstetrics and Gynecology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Department of Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seoul, South Korea.
Gynecol Minim Invasive Ther. 2024 Oct 21;13(4):253-259. doi: 10.4103/gmit.gmit_3_24. eCollection 2024 Oct-Dec.
The objective is to evaluate the feasibility and safety of ArtiSential for performing minimally invasive surgeries for gynecological cancers.
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.
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.
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.
评估ArtiSential用于妇科癌症微创手术的可行性和安全性。
2021年11月至2022年4月期间,我们在韩国的10家三级医疗机构进行了一项前瞻性观察研究。符合条件的患者年龄在18岁及以上,计划接受妇科癌症微创手术。我们收集了基线特征、手术信息和术后结果。主要终点是比较使用ArtiSential进行妇科癌症手术所需的手术时间与使用传统腹腔镜器械或机器人进行手术报告的手术时间。次要终点是评估与传统腹腔镜器械或机器人相比,使用ArtiSential进行妇科癌症手术的手术结果,并收集手术过程中操作人员对设备改进方面的反馈。
本研究共纳入40例患者,其中子宫内膜癌19例,宫颈癌15例,卵巢癌6例。平均手术时间为187.0±49.2分钟,手术过程中未出现并发症。34例患者进行了盆腔淋巴结评估,其中22例(64.7%)患者使用了ArtiSential设备,平均评估时间为40.3±19.4分钟。大多数使用ArtiSential设备的外科医生报告称,其性能略优于传统腹腔镜器械。
已证明在早期妇科癌症治疗中,使用ArtiSential设备进行微创手术是可行且安全的。