Hysteroscopic endometrial biopsy is one of the most common procedures in gynecology. For patients with atrophic or hypotrophic endometrium, typical of menopausal women, the "chip biopsy" technique is often preferred as it provides adequate tissue samples for accurate histological examination. Recently, the "rail biopsy" technique has also been adopted at IRCCS AOUBO for biopsies in similar cases. Currently, the choice between these techniques depends largely on operator preference and experience, as there is no strong evidence favoring one over the other in terms of efficacy, safety, or tolerability.
This observational, single-center, cross-sectional, prospective, non-profit study aims to compare the procedure duration of "chip biopsy" versus "rail biopsy" in patients requiring endometrial biopsy of atrophic or hypotrophic endometrium. The study is expected to last approximately 14 months. Approximately 156 patients will be enrolled.
Age ≥ 48 years and ≤ 75 years
Women with atrophic endometrium, candidates for endometrial biopsy
Informed consent obtained for participation in the study and for the processing of personal data
Presence of intrauterine fibroids, polyps, and adhesions;
Current or recent (< 3 months) use of anticoagulant drugs and/or Selective Estrogen Receptor Modulators (SERMs);
Previous confirmed diagnosis of endometrial cancer;
Suspected active pelvic inflammation or history of recent pelvic inflammation (< 6 months);
The recruitment of the study population will take place at the Hysteroscopy Outpatient Clinic of the Unit of Gynecology and Human Reproduction Physiopathology, IRCCS AOUBO. Patients referred to this clinic with an indication for diagnostic and/or operative hysteroscopy will undergo a thorough preliminary clinical evaluation to assess their eligibility for study enrollment (women with atrophic or hypotrophic endometrium requiring endometrial biopsy).
Cohort
Prospective
Not listed
To compare the duration of procedures performed using two different techniques for endometrial biopsy in patients requiring sampling of hypotrophic or atrophic endometrium: 'chip biopsy' and 'rail biopsy'
Time required to perform the hysteroscopic endometrial biopsy technique, measured in seconds from entry into the uterine cavity to completion of the procedure itself (excluding the time needed for removal of the resected tissue), during hysteroscopy
To compare the safety of the procedure between the two endometrial biopsy techniques.
Adverse events (e.g., vasovagal syndromes, bleeding, uterine perforations, or other injuries to the uterus and surrounding organs)
To compare the adequacy of the tissue obtained for histological analysis between the two endometrial biopsy techniques.
Pathologist's assessment regarding specific factors (e.g., tissue quantity, absence of crushing and/or tearing and/or electrocautery artifacts and/or improper fixation)
To compare the need for additional accessory instruments between the two endometrial biopsy techniques.
Number of instruments used
Pain intensity assessed by Visual Analog Scale (VAS)
Pain intensity measured using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain.
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