Salehi Sahar, Åvall-Lundqvist Elisabeth, Legerstam Berit, Carlson Joseph W, Falconer Henrik
Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden; Division of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden.
Department of Oncology, Linköping University, Linköping, Sweden; Department of Clinical Experimental Medicine, Linköping University, Linköping, Sweden; Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.
Eur J Cancer. 2017 Jul;79:81-89. doi: 10.1016/j.ejca.2017.03.038. Epub 2017 Apr 29.
To investigate if robot-assisted laparoscopic surgery (RALS) was non-inferior to laparotomy (LT) in harvesting infrarenal paraaortic lymph nodes in patients with presumed stage I-II high-risk endometrial cancer.
Patients with histologically proven endometrial cancer, presumed stage I-II with high-risk tumour features, were randomised to hysterectomy, bilateral salpingo-oophorectomy, pelvic and paraaortic lymphadenectomy by either RALS or LT. Primary outcome was paraaortic lymph node count. Secondary outcomes were perioperative events, postoperative complications and total health care cost.
Overall 120 patients were randomised and 96 patients were included in the per protocol analysis. Demographic, clinical and tumour characteristics were evenly distributed between groups. Mean (±SD) paraaortic lymph node count was 20.9 (±9.6) for RALS and 22 (±11, p = 0.45) for LT. The difference of means was within the non-inferiority margin (-1.6, 95% CI -5.78, 2.57). Mean pelvic node count was lower after RALS (28 ± 10 versus 22 ± 8, p < 0.001). There was no difference in perioperative complications or readmissions between the groups. Operation time was longer (p < 0.001) but total blood loss less (<0.001) and hospital stay shorter (<0.001) in RALS group than LT group. Health care costs for RALS was significantly lower (mean difference $1568 USD/€1225 Euro, p < 0.05).
Our results demonstrate non-inferiority in paraaortic lymph node count, comparable complication rates, shorter hospital length and lower total cost for RALS over laparotomy. Generalisability of the latter finding requires a high-volume setting and high surgical proficiency. In women with high-risk endometrial cancer confined to the uterus, RALS is a valid treatment modality.
ClinicalTrials.govNCT01847703.
探讨在假定为I-II期高危子宫内膜癌患者中，机器人辅助腹腔镜手术（RALS）在获取肾下主动脉旁淋巴结方面是否不劣于剖腹手术（LT）。
组织学确诊为子宫内膜癌、假定为具有高危肿瘤特征的I-II期患者，被随机分为接受RALS或LT进行子宫切除术、双侧输卵管卵巢切除术、盆腔及主动脉旁淋巴结清扫术。主要结局指标为主动脉旁淋巴结计数。次要结局指标为围手术期事件、术后并发症及总医疗费用。
共120例患者被随机分组，96例患者纳入符合方案分析。人口统计学、临床及肿瘤特征在两组间分布均衡。RALS组主动脉旁淋巴结平均（±标准差）计数为20.9（±9.6），LT组为22（±11，p = 0.45）。均值差异在非劣效界值内（-1.6，95%可信区间-5.78，2.57）。RALS术后盆腔淋巴结平均计数更低（28 ± 10对22 ± 8，p < 0.001）。两组间围手术期并发症或再入院情况无差异。RALS组手术时间更长（p < 0.001），但总失血量更少（<0.001），住院时间更短（<0.001）。RALS的医疗费用显著更低（平均差异1568美元/1225欧元，p < 0.
