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.
Study Type
OBSERVATIONAL
Enrollment
156
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy
RECRUITINGTo 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
Time frame: 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)
Time frame: During hysteroscopy
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)
Time frame: Upon delivery of the histological report (within 1 month from hysteroscopy)
To compare the need for additional accessory instruments between the two endometrial biopsy techniques.
Number of instruments used
Time frame: During hysteroscopy
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.
Time frame: administered after hysteroscopy (within 24 hours)
Pain quality assessed by McGill Pain Questionnaire (MPQ)
Pain quality measured using the McGill Pain Questionnaire (MPQ), with total scores ranging from 0 to 78, where higher scores indicate greater pain severity.
Time frame: administered after hysteroscopy (within 24 hours)
Anxiety and depression assessed by Hospital Anxiety and Depression Scale (HADS)
Anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS), consisting of two subscales (anxiety and depression), each ranging from 0 to 21, where higher scores indicate greater symptom severity.
Time frame: administered after hysteroscopy (within 24 hours)
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