Asymptomatic Women With Thick Endometrium: Hysteroscopic and Histopathological Report

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age40+
SponsorSohag University

About this trial

The primary objective of this study is to determine the histopathological diagnosis of endometrial tissue obtained from asymptomatic postmenopausal women with incidentally detected thickened endometrium, and to evaluate the diagnostic correlation between hysteroscopic findings and final histopathological results.

The secondary objectives are to describe the hysteroscopic findings in asymptomatic postmenopausal women with thickened endometrium. Estimate the prevalence of premalignant and malignant endometrial lesions in this population. Evaluate the diagnostic accuracy of hysteroscopy using histopathology as the gold standard. Assess the relationship between endometrial thickness and histopathological outcomes , create a structure risk assessment for predictors of pathological endometrium.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

sohag outpatient clinic patient

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Findings classified per ESGE criteria: normal, atrophic, polyp, fibroid, endometrial hyperplasia (regular or irregular thickening), or suspicious (friable, irregular vascularity, necrosis). All procedures will be video-recorded for offline blinded review

Findings classified per ESGE criteria: normal, atrophic, polyp, fibroid, endometrial hyperplasia (regular or irregular thickening), or suspicious (friable, irregular vascularity, necrosis). All procedures will be video-recorded for offline blinded review. Targeted biopsies will be performed from focal lesions using 3-mm grasping forceps. For diffuse thickening (\>50% cavity or uniform thickening ≥5 mm without focal lesion), systematic sampling using a 3-mm mechanical resector or Pipelle curette. Separate specimens from each uterine horn and lower segment. Histopathological evaluation will be performed blindly irrespective to results of ultrasonography and hysteroscopy. Specimens will be fixed in 10% neutral buffered formalin, paraffin-embedded, sectioned at 4 μm, H\&E-stained. Reviewed by two consultant pathologists blinded to hysteroscopy findings. In patients with inadequate biopsy with no risk factor or bleeding, ultrasonography will be repeated after 4 months.

Time frame
2 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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