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

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

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

Study Overview

• Status: Unknown
• Conditions: Endometrial Polyp.; Malignant and Pre-malignant Changes in the Polyp
• Intervention / Treatment: Procedure: Hysteroscopic polypectomy

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 Type: Interventional
• Enrollment (Anticipated): 1400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Carmel Medical Center
    • Contact: Arie Lissak, MD; Phone Number: 97248250637; Email: lissak_arie@clalit.org.il
    • Principal Investigator: Arie Lissak, MD

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Rate of complications during or around the operation	3 years
Correlation between the sonographic characteristics and histopathological findings	3 years

Collaborators and Investigators

• Sponsor: Arie Lissak, MD
• Investigators: Principal Investigator: Arie Lissak, MD, Carmel Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): August 1, 2014
• Study Completion (Anticipated): August 1, 2014

Study Registration Dates

• First Submitted: August 31, 2010
• First Submitted That Met QC Criteria: September 15, 2010
• First Posted (Estimate): September 16, 2010

Study Record Updates

• Last Update Posted (Estimate): December 3, 2013
• Last Update Submitted That Met QC Criteria: December 2, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Endometrial carcinoma; Endometrial hyperplasia; Endometrial polyp; Postmenopausal symptomatic women; Postmenopausal asymptomatic women
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Pathological Conditions, Anatomical; Polyps; Precancerous Conditions; Uterine Neoplasms
• Other Study ID Numbers: CMC-08-0073 CTIL