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

• ClinicalTrials.gov Identifier: NCT01203176
• Recruitment Status: Unknown
• First Posted: September 16, 2010
• Last Update Posted: December 3, 2013
• Sponsor: Arie Lissak, MD
• Information provided by (Responsible Party): Arie Lissak, MD, Carmel Medical Center

Study Description

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

Condition or disease	Intervention/treatment	Phase
Endometrial Polyp.; Malignant and Pre-malignant Changes in the Polyp	Procedure: Hysteroscopic polypectomy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1400 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Incidence of Malignant and Pre-malignant Findings in Endometrial Polyp in Asymptomatic and Symptomatic Postmenopausal Women
• Study Start Date: September 2010
• Estimated Primary Completion Date: August 2014
• Estimated Study Completion Date: August 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Post-menopausal symptomatic women	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.
Experimental: Post-menopausal asymptomatic women	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.

Outcome Measures

Primary Outcome Measures :

1. Incidence of malignant and pre-malignant changes in polyps removed from symptomatic and asymptomatic post-menopausal women [ Time Frame: 3 years ]
2. Sonographic characteristics and histo-pathologic measures of endometrial polyp [ Time Frame: 3 years ]

Secondary Outcome Measures :

1. Rate of complications during or around the operation [ Time Frame: 3 years ]
2. Correlation between the sonographic characteristics and histopathological findings [ Time Frame: 3 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Israel

Carmel Medical Center; Recruiting

Haifa, Israel

Contact: Arie Lissak, MD 97248250637 lissak_arie@clalit.org.il

Principal Investigator: Arie Lissak, MD

Sponsors and Collaborators

Arie Lissak, MD

Investigators

• Principal Investigator: Arie Lissak, MD; Carmel Medical Center

More Information

• Responsible Party: Arie Lissak, MD, Head of gynecologic minimally invasive surgery unit, Carmel Medical Center., Carmel Medical Center
• ClinicalTrials.gov Identifier: NCT01203176
• Other Study ID Numbers: CMC-08-0073 CTIL
• First Posted: September 16, 2010
• Last Update Posted: December 3, 2013
• Last Verified: December 2013

Keywords provided by Arie Lissak, MD, Carmel Medical Center:

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

Additional relevant MeSH terms:

Uterine Neoplasms; Precancerous Conditions; Polyps; Pathological Conditions, Anatomical; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female