In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids: Impact on Size and Vascularization.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Bleeding
研究概览
简要总结
To evaluate feasibility and efficacy of in-office hysteroscopic ablation of submucous uterine fibroid using diode laser
详细描述
A pilot study was conducted between January 2018 and January 2019 in a tertiary care university hospital. Patients with at least one symptomatic, class 0-2 of FIGO classification, uterine fibroid of ≤ 7cm in size were eligible for inclusion. Evaluation of the changes in fibroid size and vascularity was performed using 3D Doppler ultrasonography. Vaporization of the fibroid core was conducted using a 1470nm wavelength diode laser inserted through the hysteroscope's working channel. Primary outcome was the evaluation of the fibroid volume before and at 2 months after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •symptomatic patients without desire of future fertility (symptoms included heavy menstrual bleeding, abdominal discomfort, bulk symptoms such as urinary frequency, pelvic pressure and constipation),
- •grade 0-2 (FIGO classification) ≤ 7cm fibroids with evident vascularity seen by 3D-DS compared to its adjacent myometrial tissue
排除标准
- •intramural fibroids (FIGO class 3 or more),
- •>2 submucosal fibroids,
- •pelvic inflammatory disease,
- •known gynecologic malignancy,
- •severe cervical stenosis,
- •pregnancy
- •desire of future fertility,
- •previous cervical surgery
研究组 & 干预措施
Symptomatic submucosal myoma
patients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy with laser ablation of the myoma.
干预措施: hysteroscopic ablation of submucous uterine fibroid using diode laser (Device)
结局指标
主要结局
Bleeding
时间窗: before the procedure and at 3 months follow up visit
improvement of the heavy menstrual bleeding
次要结局
- fibroid volume reduction(before the procedure and at 3 months follow up visit)
- changes on the myoma vascularity(before the procedure and at 3 months follow up visit)
研究者
Sergio Haimovich
Director of the Gynecology Department at the Laniado Hospital
Ariel University