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

NCT01203176 | Unknown

• 1 other identifier: CMC-08-0073 CTIL
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Rate of complications during or around the operation

  3 years

• Correlation between the sonographic characteristics and histopathological findings

  3 years

Study Arms (2)

Post-menopausal symptomatic women

ACTIVE COMPARATOR

Procedure: Hysteroscopic polypectomy

Post-menopausal asymptomatic women

EXPERIMENTAL

Procedure: Hysteroscopic polypectomy

Interventions

Hysteroscopic polypectomy PROCEDURE

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.

Post-menopausal asymptomatic women; Post-menopausal symptomatic women

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arie Lissak, MD: lead

Study Sites (1)

Carmel Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms; Endometrial Hyperplasia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Arie Lissak, MD

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of gynecologic minimally invasive surgery unit, Carmel Medical Center.

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 16, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 3, 2013

Record last verified: 2013-12

Locations

IL (1)