Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Theme Cancer, Karolinska University Hospital, Stockholm, Sweden
Department of Oncology and Department of Clinical Experimental Medicine, Linköping University, Linköping, Sweden.
Int J Gynecol Cancer. 2019 Jan;29(1):86-93. doi: 10.1136/ijgc-2018-000019.
In the Robot Assisted Surgery for High Risk Endometrial Cancer (RASHEC) trial, patients with high-risk endometrial cancer were randomly assigned to robot-assisted laparoscopic surgery (RALS) or laparotomy for pelvic and infrarenal para-aortic lymph node dissection. We here report on self-reported lower limb lymphedema (LLL), lymphocyst formation, ascites, and long-term serious adverse events 12 months after surgery.
Patients were enrolled between 2013 and 2016, and 96 patients were included in the per protocol analysis, evenly distributed between RALS and laparotomy. Self-reported LLL was recorded using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for endometrial cancer-EN24, assessed before and 12 months after surgery. Computed tomography was assessed at baseline, 3, and 12 months. Medical charts were reviewed for serious adverse events and hospital admissions 31 to 365 days after surgery.
At 12 months after laparotomy and RALS, 61% and 50% patients, respectively, reported LLL (p = 0.31). In univariate analysis, the mean score of LLL at 12 months was significantly higher for laparotomy than for RALS (p < 0.05) and for those without abdominal drainage (p = 0.02), but was not independently associated with LLL in the multivariate analysis. Imaging showed no significant difference in lymphocyst formation or ascites between surgical modalities. No difference was found in serious adverse events and admissions to hospital for any reason. There was no agreement between lymphocyst formation or ascites and self-reported LLL.
Follow-up 1 year after comprehensive surgical staging for high-risk endometrial cancer showed no differences in self-reported LLL, findings on imaging, or SAE between laparotomy and robot-assisted surgery.
在机器人辅助高危子宫内膜癌手术（RASHEC）试验中，高危子宫内膜癌患者被随机分为机器人辅助腹腔镜手术（RALS）或剖腹手术进行盆腔和肾下主动脉旁淋巴结清扫术。我们在此报告手术后 12 个月时自我报告的下肢淋巴水肿（LLL）、淋巴囊肿形成、腹水和长期严重不良事件。
患者于 2013 年至 2016 年期间入组，并进行了方案分析，共纳入 96 例患者，平均分配至 RALS 和剖腹手术组。自我报告的 LLL 使用欧洲癌症研究与治疗组织生活质量问卷子宫内膜癌-EN24 进行记录，在手术前和手术后 12 个月进行评估。基线、3 个月和 12 个月时进行计算机断层扫描评估。手术后 31 至 365 天，审查医疗记录以确定严重不良事件和住院情况。
手术后 12 个月，剖腹手术组和 RALS 组分别有 61%和 50%的患者报告 LLL（p=0.31）。单因素分析显示，剖腹手术组的 LLL 平均评分在手术后 12 个月时显著高于 RALS 组（p<0.05）和无腹部引流组（p=0.02），但在多因素分析中与 LLL 无独立关联。影像学检查显示两种手术方式的淋巴囊肿形成或腹水无显著差异。严重不良事件和因任何原因住院治疗的差异均无统计学意义。淋巴囊肿形成或腹水与自我报告的 LLL 之间无一致性。
高危子宫内膜癌综合外科分期手术后 1 年的随访显示，剖腹手术和机器人辅助手术之间在自我报告的 LLL、影像学检查结果或 SAE 方面均无差异。
