Evaluation of Feasibility and Effectiveness of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device: a Cohort Study
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 主要终点
- Amenorrhoea
研究概览
简要总结
All women presenting to the gynaecology outpatient clinic with heavy menstrual bleeding (HMB) in the absence of recognizable pelvic pathology, as determined by one or all of a normal pelvic ultrasound, hysteroscopy and / or endometrial biopsy, refractory to medical therapy that persists despite treatment with recommended pharmacological agents(1,2), who have no desire to preserve their fertility and are willing to have an endometrial ablation will be invited to participate. Eligible women with HMB will undergo radiofrequency G4 endometrial ablation in either an inpatient or outpatient setting according to their preference.
Outcomes will be assessed by administering postal questionnaires to measure menstrual bleeding symptoms including rates of amenorrhoea, dysmenorrhoea and life quality at baseline and at 6, and 12 months after ablative treatment. After the main study, there will be an additional evaluation of the long-term effects of outpatient ablative treatments of the endometrium by postal survey at 5 years.
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with no desire to preserve their fertility who have heavy menstrual bleeding without organic pathology (DUB) of more than six months duration
- •Associated functional disability (negative impact on life quality).
- •Lack of response to medical treatment.
- •Prepared to undergo surgical treatment without general anaesthesia
排除标准
- •Women under 25 years
- •Suspected genital tract infection
- •Uterine pathology including endometrial pathology on endometrial biopsy (e.g. endometrial hyperplasia or carcinoma) and structural lesions (e.g. uterine malformations, adhesions, polyps, submucous fibroids or extracavity fibroids > 3cm in diameter) as identified on pelvic ultrasound and/or outpatient hysteroscopy.
- •Uterine cavity length >11cm
- •Adnexal pathology
- •Previous open myomectomy or endometrial ablation / resection and classical caesarian section
- •Patients considered vulnerable (e.g. current mental illness, emotionally labile, learning difficulties, immaturity)
结局指标
主要结局
Amenorrhoea
时间窗: 6 months
Two Likert-type ordinal scales will be used to assess the change in menstrual blood loss using the questions and following response categories: 'How would you describe your menstrual periods?': 'No bleeding', 'Spotting or discharge only', 'Light bleeding', 'Moderate bleeding', 'Heavy bleeding' and 'Compared to before treatment, would you say that your heavy menstrual bleeding is: 'Much better, 'A little better', 'Same', 'Worse'. These scales will be administered in our study at 6, 12 and 60 months after the intervention.
次要结局
- Disease specific health-related quality of life(6 months)
- Visual analogue scale for assessment of pain(6 months)
研究者
Thomas Justin Clark
Professor
Birmingham Women's NHS Foundation Trust