Incidence of Malignant and Pre-malignant Findings in Endometrial Polyp in Asymptomatic and Symptomatic Postmenopausal Women
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Incidence of malignant and pre-malignant changes in polyps removed from symptomatic and asymptomatic post-menopausal women
研究概览
简要总结
The prevalence of endometrial polyp is 24% in the general population but is much higher in postmenopausal women. The incidence of malignant or pre-malignant findings in endometrial polyps ranges from 2 to 10% in menopausal women.
Removal of endometrial polyps in postmenopausal symptomatic women is the standard of care, same goes for asymptomatic women with risk factors for endometrial malignancy, however treatment of asymptomatic postmenopausal women with endometrial polyp but no risk factors is disputable.
In light of ambiguity in literature regarding the rate of malignant and pre-malignant findings in polyps in asymptomatic post-menopausal women, the investigators are asking to conduct a prospective study in order to evaluate and compare the incidence of malignant and pre-malignant changes in symptomatic and asymptomatic postmenopausal women with endometrial polyp
详细描述
Endometrial polyp is a common finding in postmenopausal women. The prevalence of endometrial polyps is 24% in the general population, but is much higher in postmenopausal in compare to premenopausal women. The incidence of malignant or pre-malignant findings in endometrial polyps ranges from 0.5 to 4.8% in the general population and from 2 to 10% in menopausal women. There is an increased risk for malignant or pre-malignant polyp in postmenopausal women and it correlates with age.
Removal of endometrial polyps in postmenopausal symptomatic (bleeding, pain, vaginal discharge) women is the standard of care, same goes for asymptomatic women with risk factors (e.g., hypertension, history of breast, ovary, endometrial or colon cancer, Tamoxifen or estrogen treatment, over-weight, no ovulation, previous endometrial hyperplasia) due to a relatively high risk for malignancy. However treatment of asymptomatic postmenopausal women endometrial polyp but no risk factors is disputable.
Article published in the recent years introduced a similar rate of involvement of malignant and pre-malignant changes in polyps removed from post-menopausal women, symptomatic and asymptomatic (3.2% versus 3.9%, respectively).
In light of ambiguity in literature regarding the rate of malignant and pre-malignant findings in polyps in asymptomatic post-menopausal women, and in light of the fact that all major studies in this field were made retrospectively, we are asking to conduct a prospective study in order to evaluate and compare the incidence of malignant and pre-malignant changes in symptomatic and asymptomatic postmenopausal women with endometrial polyp
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal symptomatic women with Ultrasonographic or other imaging findings that correlates with endometrial polyp.
- •Postmenopausal asymptomatic women with Ultrasonographic or other imaging findings that correlates with endometrial polyp
- •Women who can read and understand and sign consent form
- •Women between 18 and 80 years of age.
- •ASA (American Society of Anesthesiologist) physical status grade 1-3
排除标准
- •Histological Evidence of endometrial malignancy
- •Asymptomatic woman with endometrial polyps smaller than 4 mm with no risk factors that fulfills one of the following conditions:
- •Immune depressed or terminal illness.
- •Women under anticoagulant treatment that its discontinuation, as a precondition for medical surgical intervention, could endanger their health.
结局指标
主要结局
Incidence of malignant and pre-malignant changes in polyps removed from symptomatic and asymptomatic post-menopausal women
时间窗: 3 years
Sonographic characteristics and histo-pathologic measures of endometrial polyp
时间窗: 3 years
次要结局
- Rate of complications during or around the operation(3 years)
- Correlation between the sonographic characteristics and histopathological findings(3 years)
研究者
Arie Lissak, MD
Head of gynecologic minimally invasive surgery unit, Carmel Medical Center.
Carmel Medical Center
