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


N/A
18 Years
80 Years
Open (Enrolling)
Female
Endometrial Polyp., Malignant and Pre-malignant Changes in the Polyp

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of malignant and pre-malignant changes in polyps removed from symptomatic and asymptomatic post-menopausal women

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Arie Lissak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Carmel Medical Center

Authority:

Israel: Ministry of Health

Study ID:

CMC-08-0073 CTIL

NCT ID:

NCT01203176

Start Date:

September 2010

Completion Date:

August 2013

Related Keywords:

  • Endometrial Polyp.
  • Malignant and Pre-malignant Changes in the Polyp
  • Endometrial polyp
  • Endometrial carcinoma
  • Endometrial hyperplasia
  • Postmenopausal symptomatic women
  • Postmenopausal asymptomatic women
  • Polyps
  • Precancerous Conditions
  • Adenoma
  • Uterine Neoplasms

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