Correlation Between Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination
Condition: Endometrial Hyperplasia; Endometrial Neoplasms
MeSH terms: Endometrial Neoplasms; Endometrial Hyperplasia; Hyperplasia
Study type: Observational

Summary: 
      A prospective cohort study at a Tertiary University Hospital. From January to December 2018,
      we enrolled women with the following criteria: abnormal uterine bleeding in post-menopause,
      endometrial thickening in pre-or post-menopause; tamoxifen usage. Patients underwent office
      hysteroscopy with a 5-mm continuous-flow hysteroscope and endometrial biopsies were taken
      using miniaturized instruments. Senior operators had to foresee histopathological diagnosis
      using a questionnaire. Histopathological examination was conducted to confirm the diagnosis.
    

Detailed description: 
      Patient underwent the procedure after the menstrual phase (day 6 to 10) of a spontaneous
      menstrual cycle. All the procedures were performed by means of a continuous flow
      small-diameter hysteroscope with oval profile (maximum diameter 5 mm, minimum diameter 3.9
      mm) (Bettocchi Office Hysteroscope size 5, Karl Storz GmbH & Co., Tuttlingen, Germany) fitted
      with a 30-degree telescope of 2.9 mm gauge, using the vaginoscopic approach, without
      tenaculum and speculum, and using saline solution as distending medium at 90-100 mmHg
      pressure generated by a pneumatic cuff and measured by means of a manometer; the biopsies
      were performed with the "punch" or "grasp" technique using a 5 Fr grasping forceps inserted
      through the operating channel of the hysteroscope. In case of small intrauterine pathologies,
      they were easily removed by means of a straight bipolar electrode active by an
      electrosurgical generator (Versapoint II; Gynecare, Ethicon) used to provide a 50W power for
      the mildest vapour cutting mode (VC3).

      The hysteroscopic diagnosis of hyperplasia was based on one or more of the following
      findings: (1) focal or diffuse, papillary or polypoid, endometrial thickening, (2) Abnormal
      vascular patterns; (3) evidence of glandular cysts; (4) abnormal architecture features of
      glandular outlets (thickening, irregular gland density, dilatation). Although no consensus or
      RCTs showed agreement in describing objective criteria for EH, several trials agreed on the
      previous morphologic evaluation. [8].

      The procedures were taken by three senior gynaecologists (P.D.F, L.C., N.C) whose expertise
      and skills were equivalent. After every procedure, surgeons were asked to propose a
      suggestive histological categorization of the clinical diagnosis by means of a questionnaire,
      in order to standardize the assessment. The questionnaire was made of a progressive number
      which identified the biopsy and a multiple-choice question. Operators were asked to choose
      one from the following answers: Benign (including atrophic endometrium, proliferative
      endometrium, endometrial polyp/s); Endometrial Hyperplasia (simple or complex hyperplasia);
      Atypical Hyperplasia/Carcinoma (including atypical endometrial hyperplasia and
      adenocarcinoma) Biopsied histological samples were sent for histopathological analysis. The
      histopathological examination of all the specimens was performed at the Pathology Unit of
      University of Campania "Luigi Vanvitelli". Three senior gynecopathologists (INS), with the
      same skills and expertise, were addressed to evaluate all the biopsies
    

Intervention name(s): Office Hysteroscopy
Intervention type(s): Procedure
Intervention description(s): Patients underwent office hysteroscopy with a 5-mm continuous-flow hysteroscope and endometrial biopsies were taken using miniaturized instruments. Histopathological examination was conducted to confirm the diagnosis.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women included in this study are referred by gynaecologists of the general outpatient rooms
        of the institution's hospital
      
Biospecimen description: 
      Endometrial Biopsy
    
Keywords: Endometrial Hyperplasia; Office Hysteroscopy; Predictive values; Sensitivity