Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Patient satisfaction after using PDAs
研究概览
简要总结
With the younger patients diagnosed with asymptomatic leiomyoma, delay in the reproductive age of women, the advancement of medical technology, and the rapid development of treatment methods, there are many choices between gynecologists, gynecologists and patients because of experience and knowledge. It is not easy to make the most favorable choice for patients. This study is mainly led by a committee composed of designers, doctors, nurses and patients, and based on clinical guidelines and evidence-based medicine. Co-operating with patients with asymptomatic small leiomyoma, we want to find the influencing factors of clinical decision-making, and to establish a patient decision aid tool. We use prospective trial to verify that the use of this tool can improve patients' decision-making efficacy and further improve patient-reported outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of leiomyoma: patients with leiomyoma diagnosed by imaging examinations (ultrasound and MRI) have no clinical symptoms;
- •Female with age in 18-55 years old;
- •The maximum diameter of a single leiomyoma is less than 5m, and the number does not exceed 10 by MRI;
- •No contraindications for sedation and analgesia;
- •Patients and their families agree to join this study, and can follow up on time.
排除标准
- •History of myomectomy, including transabdominal, laparoscopic, hysteroscopy, etc.;
- •History of connective tissue diseases or radiotherapy, especially abdominal radiotherapy;
- •With pregnancy, acute inflammation of the reproductive tract, or other gynecological benign and malignant diseases such as endometriosis and ovarian tumors;
- •The maximum diameter of leiomyoma is greater than or equal to 5cm;
- •Suspected malignant tumor, such as sarcoma;
- •Those with language communication barriers and unable to cooperate with sedative and analgesic programs;
- •Abdominal scarring, when diagnosed by ultrasound transabdominal scan, has obvious sound attenuation (more than 10mm range).
结局指标
主要结局
Patient satisfaction after using PDAs
时间窗: 6-12 months
The patients in PDAs will undertake the treatment by PDAs. And we will collect the satisfaction after 12 months.
次要结局
未报告次要终点
研究者
Yu Dai
Associate Professor
Shenzhen Maternity & Child Healthcare Hospital