Center for Women's Reproductive Health, Department of Obstetrics and Gynecology, and the Division of Gynecologic Oncology, University of Alabama at Birmingham, Birmingham, Alabama; the Division of Gynecologic Oncology, University of Minnesota, Minneapolis, Minnesota; and Ochsner Health System, New Orleans, Louisiana.
Obstet Gynecol. 2018 Jul;132(1):20-27. doi: 10.1097/AOG.0000000000002646.
To evaluate the feasibility of salpingectomy compared with standard bilateral tubal ligation at the time of cesarean delivery in women with undesired fertility.
We included women at 35 weeks of gestation or greater desiring permanent sterilization at the time of cesarean delivery. Patients were randomized after skin incision to bilateral salpingectomy or bilateral tubal ligation by a computer-generated scheme. If salpingectomy could not be completed on one or both sides, bilateral tubal ligation was attempted. Primary feasibility outcomes were total operative time and bilateral completion of the randomized procedure. Secondary outcomes included clinically estimated blood loss and surgical complications up to 6 weeks postpartum. We estimated that 80 patients (40 per group) would provide greater than 80% power to identify a 10-minute difference in the primary outcome (time) with a SD of 15 minutes and a two-sided α of 0.05. Analysis was by intent to treat.
Of 221 women screened from June 2015 to April 2017, 115 (52%) consented to the study; 80 were randomized-40 to salpingectomy and 40 to bilateral tubal ligation. Groups were similar at baseline. A total of 27 bilateral salpingectomies were successfully completed compared with 38 bilateral tubal ligations (68% compared with 95%, P=.002). Total operative time was on average 15 minutes longer for salpingectomies (75.4±29.1 compared with 60.0±23.3 minutes, P=.004). No adverse outcomes directly related to the sterilization procedure were noted in either group. Although estimated blood loss of only the sterilization procedure (surgeon estimate) was greater for the salpingectomy group (median 10 [interquartile range 5-25] compared with 5 [interquartile range 5-10] cc, P<.001), total estimated blood loss and safety outcomes were similar for both groups.
Adding 15 minutes to total operative times, salpingectomy can be successfully completed in approximately two thirds of women desiring permanent contraception with cesarean delivery.
Clinicaltrials.gov, NCT02374827.
评估在剖宫产时行输卵管切除术与标准双侧输卵管结扎术相比，对于有避孕需求的女性的可行性。
我们纳入了在 35 孕周或以上、有剖宫产时行永久性绝育需求的女性。在皮肤切开后，患者通过计算机生成的方案随机分为双侧输卵管切除术或双侧输卵管结扎术。如果一侧或双侧输卵管切除术无法完成，则尝试行双侧输卵管结扎术。主要可行性结局是总手术时间和随机程序的双侧完成情况。次要结局包括术后 6 周内临床估计的出血量和手术并发症。我们估计，80 例患者（每组 40 例）将有超过 80%的把握力识别出主要结局（时间）有 10 分钟的差异，其标准差为 15 分钟，双侧 α 值为 0.05。分析采用意向治疗。
在 2015 年 6 月至 2017 年 4 月期间，共有 221 名女性接受了筛查，其中 115 名（52%）同意参与该研究；80 名患者被随机分为输卵管切除术组（40 名）和双侧输卵管结扎术组（40 名）。两组基线情况相似。与 38 例双侧输卵管结扎术相比，27 例双侧输卵管切除术成功完成（68%比 95%，P=0.002）。输卵管切除术的总手术时间平均延长了 15 分钟（75.4±29.1 比 60.0±23.3 分钟，P=0.004）。两组均未出现与绝育手术直接相关的不良结局。尽管输卵管切除术组的绝育手术（外科医生估计）出血量仅稍多（中位数 10[四分位距 5-25]比 5[四分位距 5-10]cc，P<0.001），但两组的总出血量和安全性结局相似。
在剖宫产时行输卵管切除术可成功完成，总手术时间平均延长 15 分钟，约 2/3 有避孕需求的女性希望通过剖宫产术来实现永久性避孕。
Clinicaltrials.gov，NCT02374827。
