Lawrie Theresa A, Kulier Regina, Nardin Juan Manuel
Cochrane Gynaecological, Neuro-oncology and Orphan Cancer Group, Royal United Hospital, Education Centre, Bath, UK, BA1 3NG.
Cochrane Database Syst Rev. 2015 Sep 7(9):CD003034. doi: 10.1002/14651858.CD003034.pub3.
This is an update of a review that was first published in 2002. Female sterilisation is the most popular contraceptive method worldwide. Several techniques exist for interrupting the patency of fallopian tubes, including cutting and tying the tubes, damaging the tube using electric current, applying clips or silicone rubber rings, and blocking the tubes with chemicals or tubal inserts.
To compare the different tubal occlusion techniques in terms of major and minor morbidity, failure rates (pregnancies), technical failures and difficulties, and women's and surgeons' satisfaction.
For the original review published in 2002 we searched MEDLINE and the Cochrane Central Register of Controlled Trials (CENTRAL). For this 2015 update, we searched POPLINE, LILACS, PubMed and CENTRAL on 23 July 2015. We used the related articles feature of PubMed and searched reference lists of newly identified trials.
All randomized controlled trials (RCTs) comparing different techniques for tubal sterilisation, irrespective of the route of fallopian tube access or the method of anaesthesia.
For the original review, two review authors independently selected studies, extracted data and assessed risk of bias. For this update, data extraction was performed by one author (TL) and checked by another (RK). We grouped trials according to the type of comparison evaluated. Results are reported as odds ratios (OR) or mean differences (MD) using fixed-effect methods, unless heterogeneity was high, in which case we used random-effects methods.
We included 19 RCTs involving 13,209 women. Most studies concerned interval sterilisation; three RCTs involving 1632 women, concerned postpartum sterilisation. Comparisons included tubal rings versus clips (six RCTs, 4232 women); partial salpingectomy versus electrocoagulation (three RCTs, 2019 women); tubal rings versus electrocoagulation (two RCTs, 599 women); partial salpingectomy versus clips (four RCTs, 3827 women); clips versus electrocoagulation (two RCTs, 206 women); and Hulka versus Filshie clips (two RCTs, 2326 women). RCTs of clips versus electrocoagulation contributed no data to the review.One year after sterilisation, failure rates were low (< 5/1000) for all methods.There were no deaths reported with any method, and major morbidity related to the occlusion technique was rare.Minor morbidity was statistically significantly higher with the tubal ring than the clip (Peto OR 2.15, 95% CI 1.22 to 3.78; participants = 842; studies = 2; I² = 0%; high-quality evidence), as were technical failures (Peto OR 3.93, 95% CI 2.43 to 6.35; participants = 3476; studies = 3; I² = 0%; high-quality evidence).Major morbidity was significantly higher with the modified Pomeroy technique than electrocoagulation (Peto OR 2.87, 95% CI 1.13 to 7.25; participants = 1905; studies = 2; I² = 0%; low-quality evidence), as was postoperative pain (Peto OR 3.85, 95% CI 2.91 to 5.10; participants = 1905; studies = 2; I² = 0%; moderate-quality evidence).When tubal rings were compared with electrocoagulation, postoperative pain was reported significantly more frequently for tubal rings (OR 3.40, 95% CI 1.17 to 9.84; participants = 596; studies = 2; I² = 87%; low-quality evidence).When partial salpingectomy was compared with clips, there were no major morbidity events in either group (participants = 2198, studies = 1). The frequency of minor morbidity was low and not significantly different between groups (Peto OR 7.39, 95% CI 0.46 to 119.01; participants = 193; studies = 1, low-quality evidence). Although technical failure occurred more frequently with clips (Peto OR 0.18, 95% CI 0.08 to 0.40; participants = 2198; studies = 1; moderate-quality evidence); operative time was shorter with clips than partial salpingectomy (MD 4.26 minutes, 95% CI 3.65 to 4.86; participants = 2223; studies = 2; I² = 0%; high-quality evidence).We found little evidence concerning women's or surgeon's satisfaction. No RCTs compared tubal microinserts (hysteroscopic sterilisation) or chemical inserts (quinacrine) to other methods.
AUTHORS' CONCLUSIONS: Tubal sterilisation by partial salpingectomy, electrocoagulation, or using clips or rings, is a safe and effective method of contraception. Failure rates at 12 months post-sterilisation and major morbidity are rare outcomes with any of these techniques. Minor complications and technical failures may be more common with rings than clips. Electrocoagulation may be associated with less postoperative pain than the modified Pomeroy or tubal ring methods. Further research should include RCTs (for effectiveness) and controlled observational studies (for adverse effects) on sterilisation by minimally-invasive methods, i.e. tubal inserts and quinacrine.
这是对2002年首次发表的一篇综述的更新。女性绝育是全球最常用的避孕方法。存在多种中断输卵管通畅的技术,包括切断并结扎输卵管、用电损伤输卵管、应用夹子或硅橡胶环,以及用化学物质或输卵管插入物阻塞输卵管。
比较不同输卵管阻塞技术在严重和轻微发病率、失败率(妊娠)、技术失败和困难以及女性和外科医生满意度方面的差异。
对于2002年发表的原始综述,我们检索了MEDLINE和Cochrane对照试验中央注册库(CENTRAL)。对于此次2015年更新,我们于2015年7月23日检索了POPLINE、LILACS、PubMed和CENTRAL。我们使用了PubMed的相关文章功能,并检索了新确定试验的参考文献列表。
所有比较不同输卵管绝育技术的随机对照试验(RCT),无论输卵管进入途径或麻醉方法如何。
对于原始综述,两位综述作者独立选择研究、提取数据并评估偏倚风险。对于此次更新,数据提取由一位作者(TL)进行,并由另一位作者(RK)检查。我们根据评估的比较类型对试验进行分组。结果以比值比(OR)或均值差(MD)表示,采用固定效应方法,除非异质性很高,在这种情况下我们采用随机效应方法。
我们纳入了19项RCT,涉及13209名女性。大多数研究涉及非孕期绝育;三项涉及1632名女性的RCT涉及产后绝育。比较包括输卵管环与夹子(六项RCT,4232名女性);部分输卵管切除术与电凝术(三项RCT,2019名女性);输卵管环与电凝术(两项RCT,599名女性);部分输卵管切除术与夹子(四项RCT,3827名女性);夹子与电凝术(两项RCT,206名女性);以及Hulka夹与Filshie夹(两项RCT,2326名女性)。夹子与电凝术的RCT未为该综述提供数据。绝育后一年,所有方法的失败率都很低(<5/1000)。没有任何方法报告有死亡病例,与阻塞技术相关的严重发病率很少见。输卵管环导致的轻微发病率在统计学上显著高于夹子(Peto比值比2.15,95%置信区间1.22至3.78;参与者 = 842;研究 = 2;I² = 0%;高质量证据),技术失败也是如此(Peto比值比3.93,95%置信区间2.43至6.35;参与者 = 3476;研究 = 3;I² = 0%;高质量证据)。改良Pomeroy技术导致的严重发病率显著高于电凝术(Peto比值比2.87,95%置信区间1.13至7.25;参与者 = 1905;研究 = 2;I² = 0%;低质量证据),术后疼痛也是如此(Peto比值比3.85,95%置信区间2.91至5.10;参与者 = 1905;研究 = 2;I² = 0%;中等质量证据)。当比较输卵管环与电凝术时,输卵管环术后疼痛的报告频率显著更高(比值比3.40,95%置信区间1.17至9.84;参与者 = 596;研究 = 2;I² = 87%;低质量证据)。当比较部分输卵管切除术与夹子时,两组均未发生严重发病事件(参与者 = 2198,研究 = 1)。轻微发病率的频率较低,两组之间无显著差异(Peto比值比7.39,95%置信区间0.46至119.01;参与者 = 193;研究 = 1,低质量证据)。尽管夹子导致的技术失败更频繁(Peto比值比0.18,95%置信区间0.08至0.40;参与者 = 2198;研究 = 1;中等质量证据);但夹子的手术时间比部分输卵管切除术短(均值差4.26分钟,95%置信区间3.65至4.86;参与者 = 2223;研究 = 2;I² = 0%;高质量证据)。我们几乎没有发现关于女性或外科医生满意度的证据。没有RCT比较输卵管微插入物(宫腔镜绝育)或化学插入物(奎纳克林)与其他方法。
通过部分输卵管切除术、电凝术或使用夹子或环进行输卵管绝育是一种安全有效的避孕方法。绝育后12个月的失败率和严重发病率在这些技术中均很少见。轻微并发症和技术失败在使用环时可能比使用夹子更常见。电凝术可能比改良Pomeroy或输卵管环方法导致的术后疼痛更少。进一步的研究应包括关于微创方法(即输卵管插入物和奎纳克林)绝育的RCT(用于有效性)和对照观察性研究(用于不良反应)。