Relation Between Human Epididymis Protein 4 (HE4) and Endometrial Pathology in Patients With Postmenopausal Bleeding
Condition: Postmenopausal Bleeding
MeSH terms: Uterine Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      All patients included in the study had single or multiple episodes of postmenopausal bleeding
      with an endometrial thickness of more than 5mm.

      full history, general and local examination were done. Transvaginal ultrasound (TVS) was
      performed .The uterus was scanned in the sagittal plane. The double-layer ET was measured at
      the widest point between the endometrial-myometrial interfaces.the level of HE4 was measured.
      All women underwent hystrospopic guided endometrial biopsy. Definitive management was later
      performed in the form of total abdominal hysterectomy, bilateral salpingo oophrectomy, with
      or without pelvic lymph nodal dissection and histopathological examination.
    

Detailed description: 
      All patients included in the study had single or multiple episodes of postmenopausal bleeding
      with an endometrial thickness of more than 5mm.

      Full history was taken , the number of episodes of postmenopausal bleeding, and previous
      investigations and current medications), general examination was performed and local
      examination was performed for all patients.

      Transvaginal ultrasound (TVS) was performed .The uterus was scanned in the sagittal plane.
      The double-layer ET was measured at the widest point between the endometrial-myometrial
      interfaces by using electronic calipers. If there was fluid in the uterine cavity it was
      recorded. Suspected polyp was also recorded.

      For the level of HE4: 5 ml of venous blood were withdrawn from all patients. The samples were
      left to clot. The separated sera were stored at -20˚ until all samples were obtained. Frozen
      samples were allowed to reach room temperature prior to use. Samples were then mixed
      thoroughly by gently inverting multiple times before analysis. HE4 was quantitatively assayed
      using the enzyme immunoassay (EIA) method (Fujirebio Diagnostics, Inc. Göteborg, Sweden). The
      functional sensitivity of the HE4 EIA is ≤ 25pM. The analytical specificity is 100 ± 15%.

      All patients were then submitted to hysteroscopy under general anesthesia and endometrial
      biopsy.

      After hysteroscopy and biopsy, 2 patient proved to have cervical malignancy, 2 patients were
      unfit for open surgery, and another 6 patients did not show up after. These 10 patients were
      excluded from the study leaving 90 patients eligible for final analysis .

      Definitive management was later performed in the form of total abdominal hysterectomy,
      bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection and
      histopathological examination.
    

Intervention name(s): Hysteroscopic guided fractional curretage; total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection
Intervention type(s): Procedure; Procedure
Intervention description(s): Under general anaesthesia , evaluation of the endometrial cavity was done followed by biopsy of the whole endometrial tissue; Through abdominal incision , removal of the whole uterus , both tubes and ovaries and in some cases pelvic lymph nodes removal was done
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic