An International Prospective, Non-Randomized Comparative Study with Articulating Laparoscopic Instruments in Benign Adnexal Gynecologic Surgery

Articulated laparoscopic instruments such as Artisential® offer enhanced dexterity compared with conventional tools, but evidence for their use in benign gynecologic surgery remains limited. This multicenter, prospective, non-randomized comparative study evaluated the feasibility and perioperative safety of Artisential® instruments using contemporaneous controls. Consecutive patients undergoing laparoscopic surgery for benign adnexal disease between December 2022 and August 2024 were enrolled in Korea, Taiwan, and Japan. Patients who consented underwent surgery using Artisential®, while those who declined were treated with conventional laparoscopic instruments and included as retrospectively collected controls. Propensity score matching was performed based on age, body mass index, history of previous abdominal surgery, and type of surgery. Outcomes included operation time, estimated blood loss, postoperative hospital stay, and Clavien–Dindo–graded complications. A total of 184 patients were analyzed, and 112 matched patients were included after matching. No significant differences were observed between groups in operative outcomes. No conversions or transfusions occurred, and postoperative complications were infrequent and limited to grade I superficial port-site issues. These findings support the feasibility and short-term safety of Artisential® instruments in benign adnexal surgery, although randomized trials are needed to further evaluate ergonomic and economic benefits.相较于传统手术器械，Artisential®等铰接式腹腔镜器械（articulated laparoscopic instruments）具备更优异的操作灵活性，但目前其在良性妇科手术中应用的相关临床证据仍较为有限。本项多中心、前瞻性非随机对照比较研究以同期对照患者为参照，评估了Artisential®器械应用的可行性与围手术期安全性。2022年12月至2024年8月期间，韩国、中国台湾地区及日本的所有因良性附件疾病接受腹腔镜手术的连续性患者均被纳入本研究。签署知情同意的患者将接受使用Artisential®器械的手术，未同意的患者则采用传统腹腔镜器械完成手术，并作为回顾性收集的对照样本纳入研究。研究基于患者年龄、体重指数、既往腹部手术史及手术类型开展了倾向性评分匹配（propensity score matching）。本次研究的结局指标包括手术时长、估算失血量、术后住院时长以及Clavien-Dindo分级并发症情况。本研究共纳入184例患者进行分析，经倾向性评分匹配后，最终纳入112例匹配成功的患者。两组患者的手术相关结局指标均无显著差异。本研究未出现手术中转或输血情况，术后并发症发生率极低，且仅表现为I级浅表穿刺孔相关问题。上述研究结果证实了Artisential®器械在良性附件手术中应用的可行性与短期安全性，但仍需开展随机对照试验以进一步评估其人机工效学与经济效益。