机器人辅助与传统腹腔镜手术治疗子宫内膜癌：一项随机对照试验的长期结果

机器人辅助腹腔镜已成为治疗子宫内膜癌的广泛且日益采用的微创手术方式。由于其技术优势，机器人辅助腹腔镜手术提供了诸如较低的转换率等益处，优于传统腹腔镜。然而，关于机器人辅助腹腔镜术后长期肿瘤学结局的数据仍然稀少，且仅基于回顾性队列研究。本研究旨在评估子宫内膜癌患者随机分配至机器人辅助或传统腹腔镜组后的总生存率、无进展生存率以及长期手术相关并发症。本随机对照试验在芬兰坦佩雷大学医院妇产科进行。2010年至2013年期间，101名低级别子宫内膜癌患者在术前随机分配，1:1比例，接受机器人辅助或传统腹腔镜手术。所有患者均接受腹腔镜子宫切除术、双侧输卵管卵巢切除术及盆腔淋巴清扫术。共有97名患者（机器人组49例，传统组48例）随访至少10年。生存率通过Kaplan-Meier曲线、Log-rank检验和Cox比例风险模型进行分析。二元逻辑回归分析用于分析 trocar位疝的危险因素。在多变量回归分析中，机器人辅助组的总生存率优于传统腹腔镜组（风险比0.39；95%置信区间[CI]，0.15-0.99，P=0.047）。无进展生存率无差异（Log-rank检验，P=0.598）。3年、5年和10年总生存率分别为：传统腹腔镜组98.0%（95% CI，94.0-100）与97.9%（93.8-100），91.8%（84.2-99.4）与93.7%（86.8-100），以及75.5%（64.5-87.5）与85.4%（75.4-95.4），分别对应传统和机器人组。机器人组 trocar位疝发生率较传统组高，为18.2%对4.1%（优势比5.42，95% CI，1.11-26.59，P=0.028）。淋巴囊肿、淋巴水肿或其他长期并发症在两组间无差异。结果显示，机器人辅助腹腔镜在子宫内膜癌治疗中可能带来微小的总生存优势，尽管需更大规模的随机对照试验以确认潜在的生存获益。机器人组未检测到明显的安全性信号，主要原因是长期并发症发生率差异仅在 trocar位疝方面。

Robotic-assisted laparoscopy has become a widely and increasingly used modality of minimally invasive surgery in the treatment of endometrial cancer. Due to its technical advantages, robotic-assisted laparoscopic surgery offers benefits, such as a lower rate of conversions compared to conventional laparoscopy. Yet, data on long-term oncological outcomes after robotic-assisted laparoscopy is scarce and based on retrospective cohort studies only.This study aimed to assess overall survival, progression-free survival, and long-term surgical complications in patients with endometrial cancer randomly assigned to robotic-assisted or conventional laparoscopy.This randomized controlled trial was conducted at the Department of Gynecology and Obstetrics of Tampere University Hospital, Finland. Between 2010 and 2013, 101 patients with low-grade endometrial cancer scheduled for minimally invasive surgery were randomized preoperatively 1:1 either to robotic-assisted or conventional laparoscopy. All patients underwent laparoscopic hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy. A total of 97 patients (49 in the robotic-assisted laparoscopy group and 48 in the conventional laparoscopy group) were followed up for a minimum of 10 years. Survival was analyzed using Kaplan-Meier curves, log-rank test, and Cox proportional hazard models. Binary logistic regression analysis was used to analyze risk factors for trocar site hernia.In the multivariable regression analysis, overall survival was favorable in the robotic-assisted group (hazard ratio 0.39; 95% confidence interval [CI], 0.15-0.99, P=.047) compared to the conventional laparoscopy group. There was no difference in progression-free survival (log-rank test, P=.598). The 3-, 5-, and 10-year overall survival were 98.0% (95% CI, 94.0-100) vs 97.9% (93.8-100), 91.8% (84.2-99.4) vs 93.7% (86.8-100), and 75.5% (64.5-87.5) vs 85.4% (75.4-95.4) for the conventional laparoscopy and the robotic-assisted groups, respectively. Trocar site hernia developed more often for the robotic-assisted group compared to the conventional laparoscopy group 18.2% vs 4.1% (odds ratio 5.42, 95% CI, 1.11-26.59, P=.028). The incidence of lymphocele, lymphedema, or other long-term complications did not differ between the groups.The results of this randomized controlled trial suggest a minor overall survival benefit in endometrial cancer after robotic-assisted laparoscopy compared to conventional laparoscopy. Hence, the use of robotic-assisted technique in the treatment of endometrial cancer seems safe, though larger randomized controlled trials are needed to confirm any potential survival benefit. No alarming safety signals were detected in the robotic-assisted group since the rate of long-term complications differed only in the incidence of trocar site hernia.