Asymptomatic Women With Thick Endometrium: Hysteroscopic and Histopathological Report
Postmenopausal Asymptomatic Women With Thick Endometrium: Hysteroscopic and Histopathological Report
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Esraa Mohamed mohamed elsayed Mohamed elsayed, resident
- Numero di telefono: 01067310520
- Email: esraaelsherif3000@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion criteria:
Postmenopausal asymptomatic women ≥40 years with incidentally detected endometrial thickness ≥5 mm.
Exclusion criteria:
Postmenopausal bleeding , known endometrial pathology and contraindication to hysteroscopy.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: 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. |
2 weeks
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- Soh-Med-26-6-27MS
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .