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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2013 by Carmel Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Arie Lissak, MD, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01203176
First received: August 31, 2010
Last updated: December 2, 2013
Last verified: December 2013
History of Changes
  Purpose

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 Intervention
Endometrial Polyp.
Malignant and Pre-malignant Changes in the Polyp
 Procedure: Hysteroscopic polypectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Incidence of Malignant and Pre-malignant Findings in Endometrial Polyp in Asymptomatic and Symptomatic Postmenopausal Women

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • Incidence of malignant and pre-malignant changes in polyps removed from symptomatic and asymptomatic post-menopausal women [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Sonographic characteristics and histo-pathologic measures of endometrial polyp [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of complications during or around the operation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Correlation between the sonographic characteristics and histopathological findings [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Estimated Enrollment: 1400
Study Start Date: September 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203176

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     History of Changes
Other Study ID Numbers: CMC-08-0073 CTIL 
Study First Received: August 31, 2010
Last Updated: December 2, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Carmel Medical Center:
Endometrial polyp
Endometrial carcinoma
Endometrial hyperplasia
Postmenopausal symptomatic women
Postmenopausal asymptomatic women

Additional relevant MeSH terms:
Polyps
Uterine Neoplasms
Precancerous Conditions
Pathological Conditions, Anatomical
Genital Neoplasms, Female
 Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 23, 2016