Robotic-assisted versus conventional laparoscopic surgery for endometrial cancer: long-term results of a randomized controlled trial.

IF 8.7 1区 医学 Q1 OBSTETRICS & GYNECOLOGY American journal of obstetrics and gynecology Pub Date : 2024-08-23 DOI:10.1016/j.ajog.2024.08.028
Elina Kivekäs, Synnöve Staff, Heini S A Huhtala, Johanna U Mäenpää, Kari Nieminen, Eija I Tomás, Minna M Mäenpää
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Abstract

Background: 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.

Objective: 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.

Study design: 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.

Results: 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.

Conclusion: 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.

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机器人辅助与传统腹腔镜手术治疗子宫内膜癌:随机对照试验的长期结果。
背景:机器人辅助腹腔镜手术(RALS)已成为治疗子宫内膜癌(EC)的一种微创手术方式,且应用越来越广泛。与传统腹腔镜手术(CLS)相比,机器人辅助腹腔镜手术(RALS)具有技术优势,例如转换率较低。然而,有关RALS术后长期肿瘤治疗效果的数据很少,且仅基于回顾性队列研究:本研究旨在评估随机分配接受RALS或CLS治疗的EC患者的总生存期(OS)、无进展生存期(PFS)和长期手术并发症: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位EC患者在术前按1:1随机分配到RALS或CLS。所有患者均接受了腹腔镜子宫切除术、双侧输卵管切除术和盆腔淋巴结切除术。共对97名患者(RALS组49人,CLS组48人)进行了至少10年的随访。采用卡普兰-梅耶曲线、对数秩检验和考克斯比例危险模型对生存率进行了分析。二元逻辑回归分析用于分析套管部位疝的风险因素: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=0.047)。PFS没有差异(对数秩检验,P=.598)。CLS组和RALS组的3年、5年和10年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)和75.5% (64.5-87.5) vs. 85.4% (75.4-95.4)。与CLS组相比,RALS组的套管部位疝发生率更高,为18.2%对4.1%(OR 5.42,95% CI,1.11-26.59,P=0.028)。两组淋巴囊肿、淋巴水肿或其他长期并发症的发生率没有差异:本研究结果表明,与CLS相比,RALS术后EC的OS获益较小。因此,使用RALS治疗EC似乎是安全的,但还需要更大规模的RCT研究来证实RALS的潜在生存获益。在RALS组中没有发现令人担忧的安全信号,因为长期并发症的发生率仅在套管部位疝的发生率上存在差异。
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来源期刊
CiteScore
15.90
自引率
7.10%
发文量
2237
审稿时长
47 days
期刊介绍: The American Journal of Obstetrics and Gynecology, known as "The Gray Journal," covers the entire spectrum of Obstetrics and Gynecology. It aims to publish original research (clinical and translational), reviews, opinions, video clips, podcasts, and interviews that contribute to understanding health and disease and have the potential to impact the practice of women's healthcare. Focus Areas: Diagnosis, Treatment, Prediction, and Prevention: The journal focuses on research related to the diagnosis, treatment, prediction, and prevention of obstetrical and gynecological disorders. Biology of Reproduction: AJOG publishes work on the biology of reproduction, including studies on reproductive physiology and mechanisms of obstetrical and gynecological diseases. Content Types: Original Research: Clinical and translational research articles. Reviews: Comprehensive reviews providing insights into various aspects of obstetrics and gynecology. Opinions: Perspectives and opinions on important topics in the field. Multimedia Content: Video clips, podcasts, and interviews. Peer Review Process: All submissions undergo a rigorous peer review process to ensure quality and relevance to the field of obstetrics and gynecology.
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