机器人辅助腹腔镜手术（RALS）已成为子宫内膜癌（EC）治疗中广泛且越来越多使用的微创手术方式。由于其技术优势，RALS 具有诸多优势，例如与传统腹腔镜检查 (CLS) 相比，转换率较低。然而，关于 RALS 后长期肿瘤学结果的数据很少，并且仅基于回顾性队列研究。本研究旨在随机评估 EC 患者的总生存期 (OS)、无进展生存期 (PFS) 和长期手术并发症分配至 RALS 或 CLS。这项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 年间，101 名计划接受微创手术的低级别 EC 患者在术前按 1:1 随机分配至 RALS 或 CLS。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和盆腔淋巴结切除术。共有 97 名患者（RALS 组 49 名，CLS 组 48 名）接受了至少 10 年的随访。使用 Kaplan-Meier 曲线、对数秩检验和 Cox 比例风险模型对生存进行分析。采用二元逻辑回归分析来分析套管针部位疝气的危险因素。在多变量回归分析中，与 CLS 组相比，RALS 组的 OS 较好（HR 0.39；95% CI，0.15-0.99，p=.047） 。 PFS 没有差异（对数秩检验，p=.598）。三年、五年和十年的 OS 分别为 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)、 CLS 组和 RALS 组分别为 75.5% (64.5-87.5) 和 85.4% (75.4-95.4)。与 CLS 组相比，RALS 组更常发生套管针部位疝，分别为 18.2% 和 4.1%（OR 5.42，95% CI，1.11-26.59，p=.028）。各组之间淋巴囊肿、淋巴水肿或其他长期并发症的发生率没有差异。该随机对照试验的结果表明，与 CLS 相比，RALS 后 EC 的 OS 略有改善。因此，使用 RALS 治疗 EC 似乎是安全的，但需要更大的随机对照试验来证实 RALS 的潜在生存获益。 RALS 组中没有检测到令人担忧的安全信号，因为长期并发症的发生率仅在套管针部位疝气的发生率上有所不同。版权所有 © 2024 作者。由爱思唯尔公司出版。保留所有权利。

Robotic-assisted laparoscopic surgery (RALS) has become a widely and increasingly used modality of minimally invasive surgery in the treatment of endometrial cancer (EC). Due to its technical advantages, RALS offers benefits, such as a lower rate of conversions compared to conventional laparoscopy (CLS). Yet, data on long-term oncological outcomes after RALS is scarce and based on retrospective cohort studies only.This study aimed to assess overall survival (OS), progression-free survival (PFS), and long-term surgical complications in EC patients randomly assigned to RALS or CLS.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 EC scheduled for minimally invasive surgery were randomized preoperatively 1:1 either to RALS or CLS. All patients underwent laparoscopic hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy. A total of 97 patients (49 in the RALS group and 48 in the CLS 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, OS was favorable in the RALS group (HR 0.39; 95% CI, 0.15-0.99, p=.047) compared to the CLS group. There was no difference in PFS (log-rank test, p=.598). The three-, 5- and 10-year OS 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) in the CLS and the RALS group, respectively. Trocar site hernia developed more often in the RALS group compared to the CLS group 18.2% vs. 4.1% (OR 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 RCT suggest a minor OS benefit in EC after RALS compared to CLS. Hence, the use of RALS in the treatment of EC seems safe, but larger RCTs are needed to confirm the potential survival benefit of RALS. No alarming safety signals were detected in the RALS group since the rate of long-term complications differed only in the incidence of trocar site hernia.Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.