Zullo Fulvio, Palomba Stefano, Falbo Angela, Russo Tiziana, Mocciaro Rita, Tartaglia Eduardo, Tagliaferri Piersandro, Mastrantonio Pasquale
Department of Obstetrics and Gynecology, University Magna Graecia of Catanzaro, Catanzaro, Italy.
Am J Obstet Gynecol. 2009 Mar;200(3):296.e1-9. doi: 10.1016/j.ajog.2008.10.056. Epub 2009 Jan 24.
The purpose of the study was to compare the long-term safety and efficacy of laparoscopic surgery and laparotomy approaches to early stage endometrial cancer.
This was a prospective long-term extension study of a randomized controlled study that included 84 patients with clinical stage I endometrial cancer (laparoscopic surgery group, 40 women; laparotomy group, 38 women). Safety and efficacy data were evaluated and analyzed by the intention-to-treat principle.
After a follow-up period of 78 months (interquartile range, 7; range, 19-84 months) and 79 months (interquartile range, 6; range, 22-84 months) for laparoscopic surgery and laparotomy groups, respectively, no difference in the cumulative recurrence rates (8/40 [20.0%] and 7/38 [18.4%]; P = .860) and deaths (7/40 [17.5%] and 6/38 [15.8%] patients; P = .839) was detected between groups. No significant differences in overall (P = .535) and disease-free (P = .512) survival were observed.
The laparoscopic surgery approach to early stage endometrial cancer is as safe and effective a procedure as the laparotomy approach.
本研究旨在比较腹腔镜手术和剖腹手术治疗早期子宫内膜癌的长期安全性和疗效。
这是一项对一项随机对照研究的前瞻性长期扩展研究，该随机对照研究纳入了84例临床I期子宫内膜癌患者（腹腔镜手术组40例女性；剖腹手术组38例女性）。根据意向性分析原则对安全性和疗效数据进行评估和分析。
腹腔镜手术组和剖腹手术组的随访期分别为78个月（四分位间距为7；范围为19 - 84个月）和79个月（四分位间距为6；范围为22 - 84个月），两组间累积复发率（8/40 [20.0%]和7/38 [18.4%]；P = 0.860）和死亡率（7/40 [17.5%]和6/38 [15.8%]的患者；P = 0.839）均无差异。总生存期（P = 0.535）和无病生存期（P = 0.512）也未观察到显著差异。
早期子宫内膜癌的腹腔镜手术治疗方法与剖腹手术治疗方法一样安全有效。
