Efficacy Evaluation of Laparoscopic Sonoguided-microwave Uterine Myoma Ablation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Uterine myoma ablation
研究概览
简要总结
This study mainly evaluates the resolution of uterine fibroids by microwave ablation. The medical equipment used is Ke Hui. "The Ampening ablation system is a percutaneous surgery. During laparoscopic surgery, it is directly ablated and soft, including problems that cannot be solved by partial or complete tissue ablation. "Hydrogen is used. If the expected range of ablation can be found, there is no need to wait for 3 to 6 months for ablation slowly like Haifu surgery. A fast, small, high-quality treatment that provides reference for medical treatment and helps doctors choose the most suitable treatment.
详细描述
A collection of 20 women suffering from uterine fibroids were treated with microwave fibroids ablation for symptoms of uterine fibroids, and they could be discharged the next day or two days after surgery. Schedule return visits and routine blood tests according to clinical needs, and follow up with ultrasound and questionnaires during routine return visits (1, 3, and 6 months) after surgery. In the third month after surgery, there will be another imaging report. Magnetic resonance imaging and blood tests are used to compare the changes of patients' fibroids, their physiological recovery status, and the degree of improvement in their quality of life.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who have reached the age of 20 and have not yet menopause.
- •Myoma size≧4cm.
- •Patients with submucosal fmyoma or intramural myoma of the uterus.
排除标准
- •Patients with subserosal myoma.
- •Pregnant, breastfeeding or have menopause.
- •Pelvic infections, vaginitis, cervicitis or endometritis and have not been cured.
- •Malignant diseases of the cervix and uterus.
- •Abnormal reports of clinical significance in Pap smear or thin-layer cell test.
- •Abnormal blood coagulation function or liver and kidney function, with bleeding tendency.
- •There is no safe puncture treatment route.
- •Those who have installed intrauterine contraceptive device or Pacemaker.
- •Those who cannot perform vaginal ultrasound, such as those who have no sexual experience and do not accept hymen repair.
结局指标
主要结局
Uterine myoma ablation
时间窗: 1 momth
The ablation range of fibroids can be reduced by 50%, measured by MRI cubic centimeter volume.
Improve bleeding
时间窗: 3 momths
The hemoglobin changes before and 3 months after the operation are used to evaluate the improvement of patients' bleeding problems.
次要结局
- Reduce days in hospital(6 momths)