An interventional study of Hysteroscopic polypectomy in Endometrial Polyp. and Malignant and Pre-malignant Changes in the Polyp, sponsored by Arie Lissak, MD. Status unknown at 1 site in Israel. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-12-03.
Sponsored by Arie Lissak, MD · Not applicable, Interventional, and Diagnostic
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
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
255 studies on the registry are indexed under Uterine Neoplasms; 64 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 49 across 181 interventional studies indexed under Uterine Neoplasms.
Browse Uterine Neoplasms studies →This is the only study on the registry with Arie Lissak, MD as lead sponsor.
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Exclusion Criteria:
Asymptomatic woman with endometrial polyps smaller than 4 mm with no risk factors that fulfills one of the following conditions:
Procedure: Hysteroscopic polypectomy
Procedure: Hysteroscopic polypectomy
Hysteroscopy is a well established minimally invasive surgery method for diagnostic and intervention operations inside the uterine cavity. Using this method one can observe the endometrium and remove polyps.
Incidence of malignant and pre-malignant changes in polyps removed from symptomatic and asymptomatic post-menopausal women
Time frame: 3 years
Sonographic characteristics and histo-pathologic measures of endometrial polyp
Time frame: 3 years
Rate of complications during or around the operation
Time frame: 3 years
Correlation between the sonographic characteristics and histopathological findings
Time frame: 3 years
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