Cooper K G, Bain C, Parkin D E
Department of Obstetrics and Gynaecology, Aberdeen Royal Infirmary, UK.
Lancet. 1999 Nov 27;354(9193):1859-63. doi: 10.1016/S0140-6736(99)04101-X.
Various new endometrial ablation techniques have emerged for the treatment of menorrhagia. We undertook a randomised controlled trial comparing one new technique, microwave endometrial ablation (MEA), with a proven procedure, transcervical resection of the endometrium (TCRE), for women with heavy menstrual loss.
263 eligible and consenting women, referred for endometrial ablative surgery, were randomly assigned MEA (Microsulis plc, Waterlooville, Hampshire, UK; n=129) or TCRE (n=134). 230 participants were needed to give 80% power of demonstrating a 15% difference in satisfaction with treatment. All procedures were done under general anaesthesia 5 weeks after endometrial thinning with goserelin 3.6 mg. Questionnaires were completed at recruitment and at 12 months' follow-up. The primary outcome measures were patients' satisfaction with and the acceptability of treatment. Analysis was by intention to treat among women followed up to 12 months (n=116 MEA, n=124 TCRE).
At 12 months, 89 (77%) women in the MEA group and 93 (75%) in the TCRE group were totally or generally satisfied with their treatment (95% CI for difference -12 to 17) and 109 (94%) versus 112 (90%) found it acceptable (-11 to 35). Mean operating times were shorter for MEA than for TCRE (11.4 vs 15.0 min, p=0.001) and the postoperative stay slightly but not significantly shorter. One blunt perforation occurred in each study group resulting in one immediate hysterectomy (TCRE group). Of eight health-related quality of life dimensions, all were improved after MEA (six significantly) and seven were improved after TCRE (all significantly).
Both techniques achieved high rates of satisfaction and acceptability and both improved quality of life after 1 year. However, we cannot exclude a difference in satisfaction between the groups of less than 15%. MEA seems a suitable alternative to TCRE.
各种新的子宫内膜去除技术已出现用于治疗月经过多。我们进行了一项随机对照试验,比较一种新技术——微波子宫内膜去除术(MEA)与一种已证实的手术——经宫颈子宫内膜切除术(TCRE),用于治疗月经过多的女性。
263名符合条件并同意参与的因子宫内膜去除手术前来就诊的女性被随机分配接受MEA(英国汉普郡滑铁卢市Microsulis plc公司;n = 129)或TCRE(n = 134)。需要230名参与者才能有80%的把握证明治疗满意度有15%的差异。所有手术均在使用3.6毫克戈舍瑞林使子宫内膜变薄5周后在全身麻醉下进行。在招募时和随访12个月时完成问卷调查。主要结局指标是患者对治疗的满意度和可接受性。分析是在意向性治疗基础上对随访至12个月的女性进行(MEA组n = 116,TCRE组n = 124)。
在12个月时,MEA组89名(77%)女性和TCRE组93名(75%)女性对其治疗完全或总体满意(差异的95%置信区间为 -12至17),109名(94%)与112名(90%)认为治疗可接受(-11至35)。MEA的平均手术时间比TCRE短(11.4对15.0分钟,p = 0.001),术后住院时间稍短但无显著差异。每个研究组均发生1例钝性穿孔,导致1例立即行子宫切除术(TCRE组)。在八个与健康相关的生活质量维度中,MEA后所有维度均有改善(六个维度显著改善),TCRE后七个维度均有改善(均显著改善)。
两种技术均实现了高满意度和可接受率,且在1年后均改善了生活质量。然而,我们不能排除两组之间满意度差异小于15%的情况。MEA似乎是TCRE的合适替代方法。