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Completed

NCT Number: NCT03917147

Correlation Between Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"

Naples, 80131, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • abnormal uterine bleeding in post-menopause
  • ultrasonographic detection of endometrial thickening in pre-menopause
  • ultrasonographic detection of endometrial thickening in post-menopause
  • follow-up after Tamoxifen-based therapy regimens

Exclusion criteria

  • severe urinary symptoms
  • history of severe comorbidities (autoimmune disorders, chronic diseases and severe cardiac disease)

Treatment and study plan

Office hysteroscopy

Procedure

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.

Primary outcomes

  1. Sensitivity For Endometrial Hyperplasia

    Time frame: 12 months

  2. Correlation between histopathological and cllinical diagnosis for Endometrial Hyperplasia

    Time frame: 12 months

Secondary outcomes

  1. Negative Predictive value

    Time frame: 12 months

  2. Positive Predictive value

    Time frame: 12 months

  3. Likelihood ratio

    Time frame: 12 months

  4. Positive and negative post test probability

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

Correlation Between Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination: a Prospective Cohort Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 16, 2019
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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