Mäenpää Minna M, Nieminen Kari, Tomás Eija I, Laurila Marita, Luukkaala Tiina H, Mäenpää Johanna U
Department of Gynecology and Obstetrics, Tampere University Hospital, Tampere, Finland.
Department of Gynecology and Obstetrics, Tampere University Hospital, Tampere, Finland.
Am J Obstet Gynecol. 2016 Nov;215(5):588.e1-588.e7. doi: 10.1016/j.ajog.2016.06.005. Epub 2016 Jun 8.
Previous studies comparing robotic-assisted laparoscopic surgery to traditional laparoscopic or open surgery in gynecologic oncology have been retrospective. To our knowledge, no prospective randomized trials have thus far been performed on endometrial cancer.
We sought to prospectively compare traditional and robotic-assisted laparoscopic surgery for endometrial cancer.
This was a randomized controlled trial. From December 2010 through October 2013, 101 endometrial cancer patients were randomized to hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy either by robotic-assisted laparoscopic surgery or by traditional laparoscopy. The primary outcome measure was overall operation time. The secondary outcome measures included total time spent in the operating room, and surgical outcome (number of lymph nodes harvested, complications, and recovery). The study was powered to show at least a 25% difference in the operation time using 2-sided significance level of .05. The differences between the traditional laparoscopy and the robotic surgery groups were tested by Pearson χ test, Fisher exact test, or Mann-Whitney test.
In all, 99 patients were eligible for analysis. The median operation time in the traditional laparoscopy group (n = 49) was 170 (range 126-259) minutes and in the robotic surgery group (n = 50) was 139 (range 86-197) minutes, respectively (P < .001). The total time spent in the operating room was shorter in the robotic surgery group (228 vs 197 minutes, P < .001). In the traditional laparoscopy group, there were 5 conversions to laparotomy vs none in the robotic surgery group (P = .027). There were no differences as to the number of lymph nodes removed, bleeding, or the length of postoperative hospital stay. Four (8%) vs no (0%) patients (P = .056) had intraoperative complications and 5 (10%) vs 11 (22%) (P = .111) had major postoperative complications in the traditional and robotic surgery groups, respectively.
In patients with endometrial cancer, robotic-assisted laparoscopic surgery was faster to perform than traditional laparoscopy. Also total time spent in the operation room was shorter in the robotic surgery group and all conversions to laparotomy occurred in the traditional laparoscopy group. Otherwise, the surgical outcome was similar between the groups. Robotic surgery offers an effective and safe alternative in the surgical treatment of endometrial cancer.
以往比较机器人辅助腹腔镜手术与传统腹腔镜手术或开放手术在妇科肿瘤学中的应用的研究均为回顾性研究。据我们所知,迄今为止尚未对子宫内膜癌进行前瞻性随机试验。
我们旨在前瞻性比较传统腹腔镜手术与机器人辅助腹腔镜手术治疗子宫内膜癌的效果。
这是一项随机对照试验。从2010年12月至2013年10月,101例子宫内膜癌患者被随机分为接受机器人辅助腹腔镜手术或传统腹腔镜手术进行子宫切除术、双侧输卵管卵巢切除术和盆腔淋巴结清扫术。主要观察指标为总手术时间。次要观察指标包括在手术室的总时长以及手术结果(获取的淋巴结数量、并发症和恢复情况)。该研究旨在使用双侧显著性水平0.05显示手术时间至少有25%的差异。传统腹腔镜手术组与机器人手术组之间的差异通过Pearson χ检验、Fisher精确检验或Mann-Whitney检验进行分析。
共有99例患者符合分析条件。传统腹腔镜手术组(n = 49)的中位手术时间为170(范围126 - 259)分钟,机器人手术组(n = 50)为139(范围86 - 197)分钟(P < 0.001)。机器人手术组在手术室的总时长更短(228分钟对197分钟,P < 0.001)。传统腹腔镜手术组有5例转为开腹手术,而机器人手术组无(P = 0.027)。在切除的淋巴结数量、出血量或术后住院时长方面无差异。传统手术组和机器人手术组分别有4例(8%)和0例(0%)患者发生术中并发症(P = 0.056),分别有5例(10%)和11例(22%)患者发生术后严重并发症(P = 0.111)。
对于子宫内膜癌患者,机器人辅助腹腔镜手术的实施速度比传统腹腔镜手术更快。机器人手术组在手术室的总时长也更短,且所有转为开腹手术的情况均发生在传统腹腔镜手术组。除此之外,两组的手术结果相似。机器人手术为子宫内膜癌的手术治疗提供了一种有效且安全的替代方案。