Incidence of Malignant and Premalignant Endometrial Polyp in Asymptomatic and Symptomatic Postmenopausal Women

Not Applicable

• Conditions: Endometrial Polyp.; Malignant and Pre-malignant Changes in the Polyp
• Interventions: Procedure: Hysteroscopic polypectomy

• Registration Number: NCT01203176
• Lead Sponsor: Arie Lissak, MD

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2010-08-31
• Study Start: 2010-09
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-02
• Last Update Posted: 2013-12-03
• Primary Completion: 2014-08
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1400

Inclusion Criteria

1. Postmenopausal symptomatic women with Ultrasonographic or other imaging findings that correlates with endometrial polyp.
2. Postmenopausal asymptomatic women with Ultrasonographic or other imaging findings that correlates with endometrial polyp
3. Women who can read and understand and sign consent form
4. Women between 18 and 80 years of age.
5. ASA (American Society of Anesthesiologist) physical status grade 1-3

Exclusion Criteria

1. Histological Evidence of endometrial malignancy

2. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-menopausal symptomatic women	Hysteroscopic polypectomy	-
Post-menopausal asymptomatic women	Hysteroscopic polypectomy	-

Primary Outcome Measures

Name	Time	Method
Incidence of malignant and pre-malignant changes in polyps removed from symptomatic and asymptomatic post-menopausal women	3 years
Sonographic characteristics and histo-pathologic measures of endometrial polyp	3 years

Secondary Outcome Measures

Name	Time	Method
Rate of complications during or around the operation	3 years
Correlation between the sonographic characteristics and histopathological findings	3 years

Trial Locations

Locations (1)

Carmel Medical Center; 🇮🇱 Haifa, Israel