McMartin K
Ont Health Technol Assess Ser. 2013 Oct 1;13(21):1-35. eCollection 2013.
Hysteroscopic tubal sterilization is a minimally invasive alternative to laparoscopic tubal ligation for women who want permanent contraception. The procedures involves non-surgical placement of permanent microinserts into both fallopian tubes. Patients must use alternative contraception for at least 3 months postprocedure until tubal occlusion is confirmed. Compared to tubal ligation, potential advantages of the hysteroscopic procedure are that it can be performed in 10 minutes in an office setting without the use of general or even local anesthesia.
The objective of this analysis was to determine the effectiveness and safety of hysteroscopic tubal sterilization compared with tubal ligation for permanent female sterilization.
A standard systematic literature search was conducted for studies published from January 1, 2008, until December 11, 2012.
Observational studies, randomized controlled trials (RCTs), systematic reviews and meta-analyses with 1 month or more of follow-up were examined. Outcomes included failure/pregnancy rates, adverse events, and patient satisfaction.
No RCTs were identified. Two systematic reviews covered 22 observational studies of hysteroscopic sterilization. Only 1 (N = 93) of these 22 studies compared hysteroscopic sterilization to laparoscopic tubal ligation. Two other noncomparative case series not included in the systematic reviews were also identified. In the absence of comparative studies, data on tubal ligation were derived for this analysis from the CREST study, a large, multicentre, prospective, noncomparative observational study in the United States (GRADE low). Overall, hysteroscopic sterilization is associated with lower pregnancy rates and lower complication rates compared to tubal ligation. No deaths have been reported for hysteroscopic sterilization.
A lack of long-term follow-up for hysteroscopic sterilization and a paucity of studies that directly compare the two procedures limit this assessment. In addition, optimal placement of the microinsert at the time of hysteroscopy varied among studies.
Hysteroscopic sterilization is associated with: lower pregnancy rates compared to tubal ligation (GRADE very low); lower complication rates compared to tubal ligation (GRADE very low); no significant improvement in patient satisfaction compared to tubal ligation (GRADE very low).
Hysteroscopic tubal sterilization is a minimally invasive alternative to conventional tubal ligation for women who want a permanent method of contraception. Both approaches involve closing off the fallopian tubes, preventing the egg from moving down the tube and the sperm from reaching the egg. Tubal ligation is a surgical procedure to tie or seal the fallopian tubes, and it usually requires general anesthesia. In contrast, hysteroscopic tubal sterilization can be performed in 10 minutes in an office setting without general or even local anesthesia. A tiny device called a microinsert is inserted into each fallopian tube through the vagina, cervix, and uterus without surgery. An instrument called a hysteroscope allows the doctor to see inside the body for the procedure. Once the microinserts are in place, scar tissue forms around them and blocks the fallopian tubes. Health Quality Ontario conducted a review of the effectiveness and safety of hysteroscopic tubal sterilization compared to tubal ligation. This review indicates that hysteroscopic tubal sterilization is associated with: lower pregnancy rates compared to tubal ligation; lower complication rates compared to tubal ligation; no significant improvement in patient satisfaction compared to tubal ligation. However, we found a number of limitations to the studies available on hysteroscopic tubal sterilization. Among other concerns, most studies did not include long-term follow-up and only 1 study directly compared hysteroscopic tubal sterilization to tubal ligation.
对于希望采用永久避孕方法的女性而言,宫腔镜输卵管绝育术是腹腔镜输卵管结扎术的一种微创替代方法。该手术包括通过非手术方式将永久性微型植入物放置于双侧输卵管内。术后患者必须采用其他避孕措施至少3个月,直至确认输卵管已闭塞。与输卵管结扎术相比,宫腔镜手术的潜在优势在于可在诊室环境中10分钟内完成,无需使用全身麻醉甚至局部麻醉。
本分析的目的是确定与输卵管结扎术相比,宫腔镜输卵管绝育术用于女性永久性绝育的有效性和安全性。
对2008年1月1日至2012年12月11日发表的研究进行了标准的系统文献检索。
对随访时间为1个月或更长时间的观察性研究、随机对照试验(RCT)、系统评价和荟萃分析进行了审查。结局指标包括失败/妊娠率、不良事件和患者满意度。
未检索到RCT。两项系统评价涵盖了22项宫腔镜绝育术的观察性研究。这22项研究中仅有1项(N = 93)将宫腔镜绝育术与腹腔镜输卵管结扎术进行了比较。另外还识别出两项未纳入系统评价的非对照病例系列。由于缺乏比较性研究,本分析中输卵管结扎术的数据来自CREST研究,这是美国一项大型、多中心、前瞻性、非对照观察性研究(证据质量等级:低)。总体而言,与输卵管结扎术相比,宫腔镜输卵管绝育术的妊娠率和并发症发生率更低。宫腔镜绝育术尚无死亡报告。
宫腔镜绝育术缺乏长期随访,且直接比较两种手术的研究较少,限制了本评估。此外,不同研究中宫腔镜检查时微型植入物的最佳放置位置存在差异。
与输卵管结扎术相比,宫腔镜输卵管绝育术具有以下特点:妊娠率更低(证据质量等级:极低);并发症发生率更低(证据质量等级:极低);患者满意度无显著改善(证据质量等级:极低)。
对于希望采用永久性避孕方法的女性,宫腔镜输卵管绝育术是传统输卵管结扎术的一种微创替代方法。两种方法均涉及封闭输卵管,阻止卵子沿输卵管下行以及精子与卵子结合。输卵管结扎术是一种通过结扎或封闭输卵管的外科手术,通常需要全身麻醉。相比之下,宫腔镜输卵管绝育术可在诊室环境中10分钟内完成,无需全身麻醉甚至局部麻醉。一种名为微型植入物的微小装置通过阴道、宫颈和子宫,在无手术的情况下插入每条输卵管。一种名为宫腔镜的器械使医生能够在手术过程中观察体内情况。微型植入物就位后,周围会形成瘢痕组织并阻塞输卵管。安大略省卫生质量部对宫腔镜输卵管绝育术与输卵管结扎术的有效性和安全性进行了审查。该审查表明,与输卵管结扎术相比,宫腔镜输卵管绝育术具有以下特点:妊娠率更低;并发症发生率更低;患者满意度无显著改善。然而,我们发现现有关于宫腔镜输卵管绝育术的研究存在一些局限性。除其他问题外,大多数研究未包括长期随访,且仅有1项研究直接将宫腔镜输卵管绝育术与输卵管结扎术进行了比较。