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

Endometrial Polyp. Clinical Trial

Official title:

Incidence of Malignant and Pre-malignant Findings in Endometrial Polyp in Asymptomatic and Symptomatic Postmenopausal Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01203176
• Other study ID #: CMC-08-0073 CTIL
• Status: Recruiting
• Phase: N/A
• First received: August 31, 2010
• Last updated: December 2, 2013
• Start date: September 2010
• Est. completion date: August 2014

Study information

• Verified date: December 2013
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Endometrial Polyp.
• Malignant and Pre-malignant Changes in the Polyp
• Polyps
• Precancerous Conditions
• Uterine Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Arie Lissak, MD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of malignant and pre-malignant changes in polyps removed from symptomatic and asymptomatic post-menopausal women		3 years	No
Primary	Sonographic characteristics and histo-pathologic measures of endometrial polyp		3 years	No
Secondary	Rate of complications during or around the operation		3 years	No
Secondary	Correlation between the sonographic characteristics and histopathological findings		3 years	No