用于子宫内膜癌的机器人辅助和常规腹腔镜手术：一项随机对照试验的长期结果

机器人辅助腹腔镜已成为一种在子宫内膜癌治疗中的最小侵入性手术的广泛使用的模态。由于其技术优势，机器人辅助的腹腔镜手术可提供优势，例如与常规腹腔镜相比，转化率较低。然而，在机器人辅助腹腔镜检查后长期肿瘤学结果的数据稀缺，仅基于回顾性队列研究，这项研究旨在评估整体生存，无进展的生存和长期手术并发症，并在子宫内膜癌中随机分配了随机分配的疾病，并将其随机分配给了随机疾病的传统laparoscopy。芬兰坦佩雷大学医院。在2010年至2013年之间，计划进行微创手术的101例低度子宫内膜癌患者术前随机分组1：1，以进行机器人辅助或常规的腹腔镜检查。所有患者均接受腹腔镜子宫切除术，双侧salpingo-嗜噬术和骨盆淋巴结清扫术。随访至少10年，共有97例患者（机器人辅助腹腔镜组为49例，常规腹腔镜组48例）。使用Kaplan-Meier曲线，对数秩检验和COX比例危害模型分析生存。二进制逻辑回归分析用于分析throcar部位疝的危险因素。在多变量回归分析中，与传统的laparoscoppy组相比，在机器人辅助组（危险比0.39; 95％置信区间[CI]，0.15-0.99，0.15-0.99，0.15-0.99，p = .047）中的总生存率很高。无进展生存期没有差异（对数秩检验，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机器人辅助组分别。与常规的腹腔镜检查组为18.2％vs 4.1％（优势比5.42，95％CI，1.11-26.59，p = .028）相比，机器人辅助组的疝疝频率更高。两组之间的淋巴细胞，淋巴水肿或其他长期并发症的发生率没有差异。这项随机对照试验的结果表明，与常规腹腔镜相比，在机器人辅助腹腔镜检查后，子宫内膜癌的总体生存率较小。因此，尽管需要更大的随机对照试验来确认任何潜在的生存益处，但使用机器人辅助技术来治疗子宫内膜癌似乎是安全的。在机器人辅助组中未检测到令人震惊的安全信号，因为长期并发症的发生率仅在trocar部位疝的发生率上有所不同。

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.