Correlation Between Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination

NCT03917147CompletedOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

University of Campania Luigi Vanvitelli

Enrollment

435

Start Date

2018-01-08

Completion Date

2018-10-18

Study Type

OBSERVATIONAL

Official Title

Correlation Between Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination: a Prospective Cohort Study

Interventions

Office Hysteroscopy

Conditions

Endometrial HyperplasiaEndometrial Neoplasms

Eligibility

Age Range

18 Years – 60 Years

Sex

FEMALE

Inclusion Criteria:

* abnormal uterine bleeding in post-menopause
* ultrasonographic detection of endometrial thickening in pre-menopause
* ultrasonographic detection of endometrial thickening in post-menopause
* follow-up after Tamoxifen-based therapy regimens

Exclusion Criteria:

* severe urinary symptoms
* history of severe comorbidities (autoimmune disorders, chronic diseases and severe cardiac disease)

Outcome Measures

Primary Outcomes

Sensitivity For Endometrial Hyperplasia

Time frame: 12 months

Correlation between histopathological and cllinical diagnosis for Endometrial Hyperplasia

Time frame: 12 months

Secondary Outcomes

Negative Predictive value

Time frame: 12 months

Positive Predictive value

Time frame: 12 months

Likelihood ratio

Time frame: 12 months

Positive and negative post test probability

Time frame: 12 months

Locations

Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli", Naples, Italy

Correlation Between Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination