Fergusson Rosalie J, Lethaby Anne, Shepperd Sasha, Farquhar Cindy
Obstetrics and Gynaecology, Auckland City Hospital, Auckland District Health Board, Park Rd, Grafton, Auckland, New Zealand, 1023.
Cochrane Database Syst Rev. 2013 Nov 29(11):CD000329. doi: 10.1002/14651858.CD000329.pub2.
Heavy menstrual bleeding (HMB), which includes both menorrhagia and metrorrhagia, is an important cause of ill health in women. Surgical treatment of HMB often follows failed or ineffective medical therapy. The definitive treatment is hysterectomy, but this is a major surgical procedure with significant physical and emotional complications, as well as social and economic costs. Several less invasive surgical techniques (e.g. transcervical resection of the endometrium (TCRE), laser approaches) and various methods of endometrial ablation have been developed with the purpose of improving menstrual symptoms by removing or ablating the entire thickness of the endometrium.
The objective of this review is to compare the effectiveness, acceptability and safety of techniques of endometrial destruction by any means versus hysterectomy by any means for the treatment of heavy menstrual bleeding.
Electronic searches for relevant randomised controlled trials (RCTs) targeted but were not limited to the following: the Cochrane Menstrual Disorders and Subfertility Group Register of Trials, MEDLINE, EMBASE, PsycINFO and the Cochrane CENTRAL register of trials. Attempts were made to identify trials by examining citation lists of review articles and guidelines and by performing handsearching. Searches were performed in 2007, 2008 and 2013.
Included in the review were any RCTs that compared techniques of endometrial destruction by any means with hysterectomy by any means for the treatment of heavy menstrual bleeding in premenopausal women.
Two review authors independently searched for studies, extracted data and assessed risk of bias. Risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes were estimated from the data. Outcomes analysed included improvement in menstrual blood loss, satisfaction, change in quality of life, duration of surgery and hospital stay, time to return to work, adverse events and requirements for repeat surgery due to failure of the initial surgical treatment.
Eight RCTs that fulfilled the inclusion criteria for this review were identified. For two trials, the review authors identified multiple publications that assessed different outcomes at different postoperative time points for the same women.An advantage in favour of hysterectomy compared with endometrial ablation was observed in various measures of improvement in bleeding symptoms and satisfaction rates. A slightly lower proportion of women who underwent endometrial ablation perceived improvement in bleeding symptoms at one year (RR 0.89, 95% confidence interval (CI) 0.85 to 0.93, four studies, 650 women, I(2) = 31%), at two years (RR 0.92, 95% CI 0.86 to 0.99, two studies, 292 women, I(2) = 53%) and at four years (RR 0.93, 95% CI 0.88 to 0.99, two studies, 237 women, I(2) = 79%). The same group of women also showed improvement in pictorial blood loss assessment chart (PBAC) score at one year (MD 24.40, 95% CI 16.01 to 32.79, one study, 68 women) and at two years (MD 44.00, 95% CI 36.09 to 51.91, one study, 68 women). Repeat surgery resulting from failure of the initial treatment was more likely to be needed after endometrial ablation than after hysterectomy at one year (RR 14.9, 95% CI 5.2 to 42.6, six studies, 887 women, I(2) = 0%), at two years (RR 23.4, 95% CI 8.3 to 65.8, six studies, 930 women, I(2) = 0%), at three years (RR 11.1, 95% CI 1.5 to 80.1, one study, 172 women) and at four years (RR 36.4, 95% CI 5.1 to 259.2, one study, 197 women). Most adverse events, both major and minor, were significantly more likely after hysterectomy during hospital stay. Women who had a hysterectomy were more likely to experience sepsis (RR 0.2, 95% CI 0.1 to 0.3, four studies, 621 women, I(2) = 62%), blood transfusion (RR 0.2, 95% CI 0.1 to 0.6, four studies, 751 women, I(2) = 0%), pyrexia (RR 0.2, 95% CI 0.1 to 0.4, three studies, 605 women, I(2) = 66%), vault haematoma (RR 0.1, 95% CI 0.04 to 0.3, five studies, 858 women, I(2) = 0%) and wound haematoma (RR 0.03, 95% CI 0.00 to 0.5, one study, 202 women) before hospital discharge. After discharge from hospital, the only difference that was reported for this group was a higher rate of infection (RR 0.2, 95% CI 0.1 to 0.5, one study, 172 women).For some outcomes (such as a woman's perception of bleeding and proportion of women requiring further surgery for HMB), a low GRADE score was generated, suggesting that further research in these areas is likely to change the estimates.
AUTHORS' CONCLUSIONS: Endometrial resection and ablation offers an alternative to hysterectomy as a surgical treatment for heavy menstrual bleeding. Both procedures are effective, and satisfaction rates are high. Although hysterectomy is associated with longer operating time (particularly for the laparoscopic route), a longer recovery period and higher rates of postoperative complications, it offers permanent relief from heavy menstrual bleeding. The initial cost of endometrial destruction is significantly lower than that of hysterectomy, but, because retreatment is often necessary, the cost difference narrows over time.
月经过多(HMB),包括月经量过多和子宫出血,是女性健康问题的一个重要原因。HMB的手术治疗通常在药物治疗失败或无效后进行。最终治疗方法是子宫切除术,但这是一项大型手术,会带来严重的身体和情感并发症,以及社会和经济成本。为了通过去除或消融子宫内膜的全层来改善月经症状,已经开发了几种侵入性较小的手术技术(如子宫内膜切除术(TCRE)、激光手术)和各种子宫内膜消融方法。
本综述的目的是比较通过任何手段进行子宫内膜破坏的技术与通过任何手段进行子宫切除术治疗月经过多的有效性、可接受性和安全性。
针对相关随机对照试验(RCT)进行电子检索,但不限于以下内容:Cochrane月经失调与生育力低下小组试验注册库、MEDLINE、EMBASE、PsycINFO和Cochrane临床试验中心注册库。试图通过检查综述文章和指南的引用列表以及进行手工检索来识别试验。检索在2007年、2008年和2013年进行。
纳入本综述的是任何将通过任何手段进行子宫内膜破坏技术与通过任何手段进行子宫切除术治疗绝经前女性月经过多的RCT。
两位综述作者独立检索研究、提取数据并评估偏倚风险。根据数据估计二分结果的风险比(RRs)和连续结果的平均差(MDs)。分析的结果包括月经失血改善情况、满意度、生活质量变化、手术时间和住院时间、恢复工作时间、不良事件以及因初始手术治疗失败而需要再次手术的情况。
确定了八项符合本综述纳入标准的RCT。对于两项试验,综述作者识别出多篇出版物,这些出版物评估了同一组女性在不同术后时间点的不同结果。在出血症状改善和满意度的各种衡量指标中,观察到子宫切除术相对于子宫内膜消融术具有优势。接受子宫内膜消融术的女性在一年时(RR 0.89,95%置信区间(CI)0.85至0.93,四项研究,650名女性,I² = 31%)、两年时(RR 0.92,95% CI 0.86至0.99,两项研究,292名女性,I² = 53%)和四年时(RR 0.93,95% CI 0.88至0.99,两项研究,237名女性,I² = 79%),认为出血症状有改善的比例略低。同一组女性在一年时(MD 24.40,95% CI 16.01至32.79,一项研究,68名女性)和两年时(MD 44.00,95% CI 36.09至51.91,一项研究,68名女性)的图像失血评估图(PBAC)评分也有改善。在一年时(RR 14.9,95% CI 5.2至42.6,六项研究,887名女性,I² = 0%)、两年时(RR 23.4,95% CI 8.3至65.8,六项研究,930名女性,I² = 0%)、三年时(RR 11.1,95% CI 1.5至80.1,一项研究,172名女性)和四年时(RR 36.4,95% CI 5.1至259.2,一项研究,197名女性),子宫内膜消融术后因初始治疗失败而需要再次手术的可能性比子宫切除术后更高。在住院期间,大多数不良事件,无论是重大还是轻微的,子宫切除术后发生的可能性明显更高。接受子宫切除术的女性在出院前更有可能发生败血症(RR 0.2,95% CI 0.1至0.3,四项研究,621名女性,I² = 62%)、输血(RR 0.2,95% CI 0.1至0.6,四项研究,751名女性,I² = 0%)、发热(RR 0.2,95% CI 0.1至0.4,三项研究,605名女性,I² = 66%)、穹窿血肿(RR 0.1,95% CI 0.04至0.3,五项研究,858名女性,I² = 0%)和伤口血肿(RR 0.03,95% CI 0.00至0.5,一项研究,202名女性)。出院后,该组报告的唯一差异是感染率较高(RR 0.2,95% CI 0.1至0.5,一项研究,172名女性)。对于一些结果(如女性对出血的感知以及因HMB需要进一步手术的女性比例),生成的GRADE评分较低,表明这些领域的进一步研究可能会改变估计值。
子宫内膜切除术和消融术可作为子宫切除术的替代方法用于治疗月经过多。两种手术都有效,且满意度高。尽管子宫切除术与更长的手术时间(特别是腹腔镜手术)、更长的恢复期和更高的术后并发症发生率相关,但它能永久性缓解月经过多。子宫内膜破坏的初始成本明显低于子宫切除术,但由于通常需要再次治疗,随着时间的推移成本差异会缩小。