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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Hysteroscopic polypectomy
Sponsored by
Arie Lissak, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometrial Polyp. focused on measuring Endometrial polyp, Endometrial carcinoma, Endometrial hyperplasia, Postmenopausal symptomatic women, Postmenopausal asymptomatic women

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Carmel Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Post-menopausal symptomatic women

Post-menopausal asymptomatic women

Arm Description

Outcomes

Primary Outcome Measures

Incidence of malignant and pre-malignant changes in polyps removed from symptomatic and asymptomatic post-menopausal women
Sonographic characteristics and histo-pathologic measures of endometrial polyp

Secondary Outcome Measures

Rate of complications during or around the operation
Correlation between the sonographic characteristics and histopathological findings

Full Information

First Posted
August 31, 2010
Last Updated
December 2, 2013
Sponsor
Arie Lissak, MD
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1. Study Identification

Unique Protocol Identification Number
NCT01203176
Brief Title
Incidence of Malignant and Premalignant Endometrial Polyp in Asymptomatic and Symptomatic Postmenopausal Women
Official Title
Incidence of Malignant and Pre-malignant Findings in Endometrial Polyp in Asymptomatic and Symptomatic Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Arie Lissak, MD

4. Oversight

Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Polyp., Malignant and Pre-malignant Changes in the Polyp
Keywords
Endometrial polyp, Endometrial carcinoma, Endometrial hyperplasia, Postmenopausal symptomatic women, Postmenopausal asymptomatic women

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Post-menopausal symptomatic women
Arm Type
Active Comparator
Arm Title
Post-menopausal asymptomatic women
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Hysteroscopic polypectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of malignant and pre-malignant changes in polyps removed from symptomatic and asymptomatic post-menopausal women
Time Frame
3 years
Title
Sonographic characteristics and histo-pathologic measures of endometrial polyp
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Rate of complications during or around the operation
Time Frame
3 years
Title
Correlation between the sonographic characteristics and histopathological findings
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postmenopausal symptomatic women with Ultrasonographic or other imaging findings that correlates with endometrial polyp. Postmenopausal asymptomatic women with Ultrasonographic or other imaging findings that correlates with endometrial polyp Women who can read and understand and sign consent form Women between 18 and 80 years of age. ASA (American Society of Anesthesiologist) physical status grade 1-3 Exclusion Criteria: Histological Evidence of endometrial malignancy 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arie Lissak, MD
Organizational Affiliation
Carmel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carmel Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arie Lissak, MD
Phone
97248250637
Email
lissak_arie@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Arie Lissak, MD

12. IPD Sharing Statement

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

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