METHODS: Multicenter, prospective, randomized controlled trial.
METHODS: University hospitals.
METHODS: 80 adult women undergoing office hysteroscopic polypectomy between January 2023 and March 2024 were randomized to intervention (n = 40) or control (n = 40). Exclusion criteria included the presence of endouterine pathology other than endometrial polyps solely.
METHODS: Subjects in the intervention group were treated with oral nomegestrol acetate/estradiol 1.5 mg/2.5 mg/day started taking the drug from an indefinite time in the menstrual cycle (random start) for 14 days. Subjects in the control group did not receive any pharmaceutical treatment and underwent polypectomy between days 8 and 11 of the menstrual cycle.
RESULTS: On the day of the procedure, the difference in pre- and post-office hysteroscopic polypectomy endometrial ultrasound thickness was statistically significant between the two groups, with endometrial thickness in both measurements being thinner for the intervention group (p < 0.001). In the nomegestrol acetate/estradiol-treated group, compared with the control, there was also a statistically significant difference in the physician\'s assessment of the quality of endometrial preparation (p < 0.001), the quality of visualization of the uterine cavity (p < 0.001), and satisfaction with the performance of the procedure (p < 0.001). Finally, all surgical outcomes analyzed were better in the treatment group.
CONCLUSIONS: Treatment with nomegestrol acetate/estradiol could provide rapid, satisfactory and low-cost preparation of the endometrium before office polypectomy, thus improving surgical performance and woman\'s compliance.
BACKGROUND: ClinicalTrials.gov NCT06316219.
方法:多中心,prospective,随机对照试验。
方法:大学医院。
方法:在2023年1月至2024年3月期间接受宫腔镜息肉切除术的80名成年女性被随机分为干预(n=40)或对照组(n=40)。排除标准包括仅存在子宫内膜息肉以外的内膜病理学。
方法:干预组受试者口服醋酸诺美孕酮/雌二醇1.5mg/2.5mg/天,从月经周期的无限期开始服用药物(随机开始),持续14天。对照组中的受试者未接受任何药物治疗,并在月经周期的第8天至第11天进行了息肉切除术。
结果:在手术当天,术前、术后子宫内膜超声厚度差异有统计学意义,干预组的子宫内膜厚度均较薄(p<0.001)。在醋酸诺美孕酮/雌二醇治疗组中,与对照组相比,医生对子宫内膜准备质量的评估也有统计学上的显著差异(p<0.001),子宫腔的可视化质量(p<0.001),以及对程序性能的满意度(p<0.001)。最后,治疗组的所有手术结局分析均较好.
结论:用醋酸诺美孕酮/雌二醇治疗可提供快速,在办公室息肉切除术前对子宫内膜进行令人满意且低成本的准备,从而提高手术性能和妇女的依从性。
背景:ClinicalTrials.govNCT06316219。