Randomized Prospective Study of the Effectiveness of the Truclear Device for Hysteroscopic Myomectomy on Patient Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Quality of life score
研究概览
简要总结
This study aims to evaluate the quality of life in patients treated for submucosal leiomyomas using the Truclear hysteroscopic morcellator compared to women managed medically. Study population includes women age 18 and older with symptomatic submucosal myomas. Patients will be asked to complete the Uterine Myoma Symptom and Health-related Quality of Life Questionnaire (UFS-QOL) at enrollment and at 1, 3, and 6 months after treatment.
详细描述
Submucosal myomas are a common cause of pelvic complaints and abnormal uterine bleeding (AUB) and there are many available modalities for treatment. Hysteroscopic myomectomy is a minimally invasive approach for removal of submucosal leiomyomas. Alternatively, medical management can be attempted. This study aims to evaluate the quality of life in patients treated for submucosal leiomyomas using the Truclear hysteroscopic morcellator compared to women managed medically. Study population includes women age 18 and older with symptomatic submucosal myomas. Patients will be asked to complete the Uterine Myoma Symptom and Health-related Quality of Life Questionnaire (UFS-QOL) at enrollment and at 1, 3, and 6 months after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with abnormal uterine bleeding and submucosal fibroid(s) undergoing hysteroscopic myomectomy or medical therapy with oral contraceptive pills
- •Patients with Type 0, 1 or 2 submucosal myomas
排除标准
- •Pregnant women
- •Patients with suspicion of uterine malignancy
- •Patients without submucosal fibroid seen during planned hysteroscopic myomectomy
- •Patients with active vaginal infection
- •Patients with contraindication to hysteroscopic myomectomy
- •Patients with cognitive impairment who are unable to provide consent and adequately complete the questionnaire.
研究组 & 干预措施
Study group: surgical arm
Hysteroscopic myomectomy with Truclear done on patients with abnormal uterine bleeding and submucosal fibroid(s).
干预措施: Hysteroscopic myomectomy with Truclear (Procedure)
Control group: medical arm
Medical therapy for patients with abnormal uterine bleeding/ heavy menses and submucosal fibroids
干预措施: Medical therapy (Drug)
结局指标
主要结局
Quality of life score
时间窗: Two years
Primary outcome is the health-related quality of life (HR-QOL) as reflected from UFS-QOL scores.
次要结局
- Secondary surgical outcomes(Two years)