Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Endometrial thickness (measured using a scale)
研究概览
简要总结
- The study primarily aims to evaluate the post ablative endometrium and uterus using transvaginal ultrasound to provide descriptive information as to what may be expected in the 12 months after a NovaSure ablation. Investigators believe this knowledge will help them to determine when to proceed with further evaluation postoperatively or when to counsel patients on expectant management based on ultrasonographic findings.
- Secondary aims include correlation of ultrasonographic findings to demographic patient data.
详细描述
Heavy and irregular menses affects 9-14% of gynecologic patients. Surgical can be employed intervention is sought when medical management fails. Endometrial ablation or desiccation of the endometrium using minimally invasive instruments has been utilized in this scenario. The current mainstay intervention is non-resectoscopic radio frequency ablation. These procedures have high satisfaction rates (81 to 93%) similar to hysterectomy and leave up to 47% of patients amenorrheic. Post operative complications, both short and long term, and failure rates have been well studied. A limited number of studies have been performed to assess the histologic state of the post ablative endometrium and fewer assessing the radiographic appearance of the endometrium. Therefore, this current study aims to describe the ultrasonographic appearance of the post ablative endometrium and uterus.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women of premenopausal age
- •18 years and older
- •intended ablative management of menorrhagia
排除标准
- •uterine cavity anatomic abnormality
- •previous uterine ablation procedure
- •previous cervical procedure
- •presence of submucosal fibroids
- •tissue diagnosis of endometrial hyperplasia/endometrial carcinoma
- •pregnancy and delivery less than 1 year before ablation.
结局指标
主要结局
Endometrial thickness (measured using a scale)
时间窗: 2 months
次要结局
未报告次要终点