Atrophic or Hypotrophic Endometrium
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
48 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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); * Presence of severe stenosis or obliteration of the cervical canal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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' | During hysteroscopy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare the safety of the procedure between the two endometrial biopsy techniques. | During hysteroscopy | 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. | Upon delivery of the histological report (within 1 month from hysteroscopy) | 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. | During hysteroscopy | Number of instruments used |
| Pain intensity assessed by Visual Analog Scale (VAS) | administered after hysteroscopy (within 24 hours) | 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. |
| Pain quality assessed by McGill Pain Questionnaire (MPQ) | administered after hysteroscopy (within 24 hours) | Pain quality measured using the McGill Pain Questionnaire (MPQ), with total scores ranging from 0 to 78, where higher scores indicate greater pain severity. |
| Anxiety and depression assessed by Hospital Anxiety and Depression Scale (HADS) | administered after hysteroscopy (within 24 hours) | 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. |
Countries
Italy
Contacts
CONTACTPaolo Casadio, MD
Outcome results
None listed