Department of Obstetrics and Gynaecology, Máxima Medical Centre, Postbox 7777, 5500 MB, Veldhoven, The Netherlands.
Research School Grow, Maastricht University, Maastricht, The Netherlands.
BMC Womens Health. 2022 Jun 27;22(1):257. doi: 10.1186/s12905-022-01843-6.
It is estimated that between 12 to 25% of women who undergo an endometrial ablation for heavy menstrual bleeding (HMB) are dissatisfied after two years because of recurrent menstrual bleeding and/or cyclical pelvic pain, with around 15% of these women ultimately having a hysterectomy. The insertion of a levonorgestrel-releasing intrauterine system (LNG-IUS) immediately after endometrial ablation may inactivate residual untreated endometrium and/or inhibit the regeneration of endometrial tissue. Furthermore, the LNG-IUS may prevent agglutination of the uterine walls preventing intrauterine adhesion formation associated with endometrial ablation. In these ways, insertion of an LNG-IUS immediately after endometrial ablation might prevent subsequent hysterectomies because of persisting uterine bleeding and cyclical pelvic pain or pain that arises de novo. Hence, we evaluate if the combination of endometrial ablation and an LNG-IUS is superior to endometrial ablation alone in terms of reducing subsequent rates of hysterectomy at two years following the initial ablative procedure.
METHODS/DESIGN: We perform a multicentre randomised controlled trial in 35 hospitals in the Netherlands. Women with heavy menstrual bleeding, who opt for treatment with endometrial ablation and without contraindication for an LNG-IUS are eligible. After informed consent, participants are randomly allocated to either endometrial ablation plus LNG-IUS or endometrial ablation alone. The primary outcome is the hysterectomy rate at 24 months following endometrial ablation. Secondary outcomes include women's satisfaction, reinterventions, complications, side effects, menstrual bleeding patterns, quality of life, societal costs.
The results of this study will help clinicians inform women with HMB who opt for treatment with endometrial ablation about whether concomitant use of the LNG-IUS is beneficial for reducing the need for hysterectomy due to ongoing bleeding and/or pain symptoms. Trial registration Dutch Trial registration: NL7817. Registered 20 June 2019, https://www.trialregister.nl/trial/7817 .
据估计，有 12%至 25%的因月经过多而行子宫内膜消融术的女性在两年后会因再次出现月经出血和/或周期性盆腔疼痛而感到不满，其中约 15%的女性最终行子宫切除术。在子宫内膜消融术后立即放置左炔诺孕酮宫内节育系统（LNG-IUS）可使未治疗的子宫内膜失活和/或抑制子宫内膜组织再生。此外，LNG-IUS 可防止子宫壁粘连，防止与子宫内膜消融相关的宫腔粘连形成。通过这些方式，在子宫内膜消融术后立即放置 LNG-IUS 可能会预防因持续子宫出血和周期性盆腔疼痛或新出现的疼痛而导致的后续子宫切除术。因此，我们评估了子宫内膜消融术联合 LNG-IUS 是否优于单纯子宫内膜消融术，以降低初始消融术后两年内的子宫切除术后续发生率。
方法/设计：我们在荷兰的 35 家医院进行了一项多中心随机对照试验。选择行子宫内膜消融术且无 LNG-IUS 禁忌证的月经过多女性符合入组条件。在获得知情同意后，参与者被随机分配至子宫内膜消融术+LNG-IUS 组或单纯子宫内膜消融术组。主要结局是子宫内膜消融术后 24 个月的子宫切除术率。次要结局包括女性满意度、再次干预、并发症、副作用、月经出血模式、生活质量、社会成本。
本研究的结果将帮助临床医生向选择行子宫内膜消融术治疗的 HMB 女性提供信息，了解是否联合使用 LNG-IUS 是否有助于减少因持续出血和/或疼痛症状而需要行子宫切除术。
荷兰试验注册：NL7817。注册日期：2019 年 6 月 20 日，https://www.trialregister.nl/trial/7817。
