Risk Factors and A Prediction Model of Recurrence of Uterine Fibroids
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,200
- 试验地点
- 1
- 主要终点
- The performance of the prediction model for recurrence of uterine fibroids as assessed by AUC
研究概览
简要总结
To research risk factors for recurrence of uterine fibroids and build a prediction model of recurrence of uterine fibroids to facilitate the early detection as well as the early intervention for patients who are prone to recur.
详细描述
Uterine fibroids are the most common benign tumors of female reproductive organs during childbearing age. With the emphasis on fertility preservation and the pursuit of the physical integrity, about 46% of patients prefer the conservative surgery which preserves the uterus. However, the high recurrence rate of uterine fibroids after conservative surgery does cause formidable clinical problems.
According to the literature, the recurrence rate is about 11.7% at one year after myomectomy and would increase steadily. At the eighth year of myomectomy, the recurrence rate is as high as 84.4%. During the long-term follow-up, about one-third of patients eventually require reoperation.
Recurrence not only leads to the recurrence of fibroid-related symptoms such as anemia, abdominal and pelvic pain, frequent urination and urgency, abnormal stool, etc., but also increases the burden of economic and national medical insurance, besides, it even causes serious problems such as psychological disorders, infertility, adverse pregnancy outcomes and malignant transformation, which affecting physical and mental health as well as destroying family happiness and threatening national population security.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age:18-50 years
- •Diagnosed with uterine fibroids (by ultrasound or pathology)
- •Accept myomectomy.
- •Complete clinical data.
排除标准
- •Severe infectious disease
- •Previous history of malignant tumors
- •Incomplete clinical data.
结局指标
主要结局
The performance of the prediction model for recurrence of uterine fibroids as assessed by AUC
时间窗: through study completion, about June.2025
Complete the follow-up, and compare the actual recurrence population with the predicted recurrence population to judge the performance of the prediction model. Use the AUC (Area Under Curve)
次要结局
- The fertility rate after myomectomy(about Febrary.2024)
- The degree of abdominal pain after myomectomy will be assessed by VAS(visual analogue scale, VAS)(through study completion, about June.2025)
- Numbers of risk factors of recurrent uterine fibroids as certained by statistic analysis(about June.2024)
- The recurrence rate of uterine fibroids yearly(about Febrary.2024)
- The quality of life after myomectomy will be assessed by UFS-QOL,(uterine fibroid symptom and health-related quality of life, UFS-QOL)(through study completion, about June.2025)
- The blood loss will be assessed by PBLAC (Pictorial Blood Loss Assessment Chart (PBLAC)(through study completion, about June.2025)
研究者
Wenwen Wang
Professor
Tongji Hospital
