Postmenopausal Asymptomatic Women With Thick Endometrium: Hysteroscopic and Histopathological Report
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
Patients who are fulfilling the eligible criteria of the current study after signing informed consent will undergo complete history taking, examination, and investigations such as (CBC-PT-PC-INR-LFTs-KFTs-electrolytes).
Transvaginal sonography will be performed with an expert gynaecologist using a 5-9 MHz probe (Vulson S8). Endometrial thickness will be measured in sagittal plane as double-layer thickness. Thickest point will be recorded in addition to assessment of echogenicity, patteren and vascularity.
Then operative hysteroscopy (Storze,) will be performed under regional anesthesia (spinal/epidural). Uterine cavity systematically examined using a 5-mm, 30° scope with continuous flow. 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal asymptomatic women ≥40 years with incidentally detected endometrial thickness ≥5 mm.
排除标准
- •Postmenopausal bleeding , known endometrial pathology and contraindication to hysteroscopy.
结局指标
主要结局
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
时间窗: 2 weeks
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.
次要结局
未报告次要终点
研究者
Esraa Mohamed Mohamed Elsayed
Esraa Mohamed Mohamed ELsayed
Sohag University