Department of Obstetrics and Gynecology, University of Insubria, Del Ponte Hospital, Varese, Italy.
Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
Am J Obstet Gynecol. 2017 Jun;216(6):592.e1-592.e11. doi: 10.1016/j.ajog.2017.01.027. Epub 2017 Jan 29.
Although widely adopted, the use of a uterine manipulator during laparoscopic treatment of endometrial cancer represents a debated issue, and some authors hypothesize that it potentially may cause an increased risk of relapse, particularly at specific sites.
Our aim was to evaluate the risk and site of disease recurrence, overall survival, and disease-specific survival in women who had laparoscopic surgery with and without the use of a uterine manipulator.
Data were reviewed from consecutive patients who had laparoscopic surgery for endometrial cancer staging in 7 Italian centers. Subjects were stratified according to whether a uterine manipulator was used during surgery; if so, the type of manipulator was identified. Multivariable analysis to correct for possible confounders and propensity score that matched the minimize selection bias were utilized. The primary outcome was the risk of disease recurrence. Secondary outcomes were disease-specific and overall survival and the site of recurrence, according to the use or no use of the uterine manipulator and to the different types of manipulators used.
We included 951 patients: 579 patients in the manipulator group and 372 patients in the no manipulator group. After a median follow-up period of 46 months (range,12-163 months), the rate of recurrence was 13.5% and 11.6% in the manipulator and no manipulator groups, respectively (P=.37). Positive lymph nodes and myometrial invasion of >50% were associated independently with the risk of recurrence after adjustment for possible confounders. The use of a uterine manipulator did not affect the risk of recurrence, both at univariate (odds ratio, 1.18; 95% confidence interval, 0.80-1.77) and multivariable analysis (odds ratio, 1.00; 95% confidence interval, 0.60-1.70). Disease-free, disease-specific, and overall survivals were similar between groups. Propensity-matched analysis confirmed these findings. The site of recurrence was comparable between groups. In addition, the type of uterine manipulator and the presence or not of a balloon at the tip of the device were not associated significantly with the risk of recurrence.
The use of a uterine manipulator during laparoscopic surgery does not affect the risk of recurrence and has no impact on disease-specific or overall survival and on the site of recurrence in women affected by endometrial cancer.
尽管被广泛采用,但在腹腔镜治疗子宫内膜癌过程中使用子宫操纵器仍是一个存在争议的问题,一些作者假设它可能会增加复发的风险,尤其是在特定部位。
我们旨在评估在使用和不使用子宫操纵器的腹腔镜手术中,妇女的疾病复发风险和部位、总生存率和疾病特异性生存率。
对意大利 7 个中心接受腹腔镜手术分期治疗子宫内膜癌的连续患者的数据进行了回顾。根据手术中是否使用子宫操纵器将患者分层;如果使用了,识别操纵器的类型。使用多变量分析来校正可能的混杂因素和倾向评分,以最小化选择偏倚。主要结局是疾病复发的风险。次要结局是疾病特异性和总生存率以及根据使用或不使用子宫操纵器以及使用的不同类型的操纵器的复发部位。
我们纳入了 951 名患者:579 名患者在操纵器组,372 名患者在无操纵器组。中位随访时间为 46 个月(范围 12-163 个月),操纵器组和无操纵器组的复发率分别为 13.5%和 11.6%(P=.37)。在调整可能的混杂因素后,阳性淋巴结和肌层浸润>50%与复发风险独立相关。在单变量(比值比 1.18;95%置信区间 0.80-1.77)和多变量分析(比值比 1.00;95%置信区间 0.60-1.70)中,使用子宫操纵器均不影响复发风险。无复发生存、疾病特异性生存和总生存率在两组之间相似。倾向评分匹配分析证实了这些发现。两组的复发部位相似。此外,子宫操纵器的类型以及器械末端是否有气球与复发风险无显著相关性。
在腹腔镜手术中使用子宫操纵器不会影响复发风险,对子宫内膜癌患者的疾病特异性或总生存率以及复发部位没有影响。