Comparison Between Two Hysteroscopic Biopsy Techniques in the Outpatient Setting for Sampling Hypotrophic or Atrophic Endometrium: 'Rail Biopsy' Versus 'Chip Biopsy'
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- 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'
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 48 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
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'
时间窗: 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
次要结局
- To compare the safety of the procedure between the two endometrial biopsy techniques.(During hysteroscopy)
- 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))
- To compare the need for additional accessory instruments between the two endometrial biopsy techniques.(During hysteroscopy)
- Pain intensity assessed by Visual Analog Scale (VAS)(administered after hysteroscopy (within 24 hours))
- Pain quality assessed by McGill Pain Questionnaire (MPQ)(administered after hysteroscopy (within 24 hours))
- Anxiety and depression assessed by Hospital Anxiety and Depression Scale (HADS)(administered after hysteroscopy (within 24 hours))