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

NCT ID: NCT01203176

Last Updated: 2013-12-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2014-08-31

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

Conditions

Endometrial Polyp.; Malignant and Pre-malignant Changes in the Polyp

Keywords

Endometrial polyp; Endometrial carcinoma; Endometrial hyperplasia; Postmenopausal symptomatic women; Postmenopausal asymptomatic women

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Post-menopausal symptomatic women

Group Type: ACTIVE_COMPARATOR

Hysteroscopic polypectomy

Intervention Type: PROCEDURE

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.

Post-menopausal asymptomatic women

Group Type: EXPERIMENTAL

Hysteroscopic polypectomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Arie Lissak, MD

OTHER

Sponsor Role: lead

Responsible Party

Arie Lissak, MD

Head of gynecologic minimally invasive surgery unit, Carmel Medical Center.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Arie Lissak, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Locations

Carmel Medical Center

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Facility Contacts

Arie Lissak, MD

Role: primary

Other Identifiers

CMC-08-0073 CTIL

Identifier Type: -

Identifier Source: org_study_id