A Comparative Study of Pipelle Versus Manual Vacuum Aspiration Cannula for Endometrial Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Diagnostic Yield for Endometrial Pathology
研究概览
简要总结
women globally, often requiring endometrial tissue sampling for accurate evaluation and diagnosis. Traditional office-based sampling techniques like Pipelle are widely used, but the disposable instruments can be relatively expensive in resource-limited settings. Manual Vacuum Aspiration (MVA) using a flexible cannula is an inexpensive, reusable alternative, but clinical data comparing its performance directly to Pipelle remains limited.
The objective of this randomized clinical trial is to compare Pipelle endometrial biopsy and Manual Vacuum Aspiration (MVA) cannula in terms of sample adequacy, patient satisfaction, and post-procedure complications in women presenting with abnormal uterine bleeding. Participants will be randomly assigned to undergo endometrial sampling using either a 4 mm MVA cannula or a Pipelle device without anesthesia or cervical dilation. Samples will be analyzed for histopathological diagnosis, and outcomes such as procedure pain, adequacy of tissue, and complications will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
All endometrial biopsy specimens will be evaluated independently by a consultant histopathologist who will be blinded to the participants' group allocation.
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Married women aged 35 years and above.
- •Presentation with abnormal uterine bleeding (AUB), including but not limited to metrorrhagia, menorrhagia, or postmenopausal bleeding.
- •Clinical indication for endometrial sampling for diagnostic evaluation of abnormal uterine bleeding.
- •Patient fit for both MVA and Pipelle procedures, with no contraindications to either method.
排除标准
- •Pregnancy or suspicion of pregnancy.
- •Acute pelvic inflammatory disease or active genital tract infection.
- •Current use of anticoagulant therapy or presence of bleeding disorders that pose a risk for excessive bleeding during endometrial sampling.
结局指标
主要结局
Diagnostic Yield for Endometrial Pathology
时间窗: At the time of histopathological assessment (within 7 days post-procedure)
Proportion of patients receiving a definitive histopathological diagnosis (differentiating benign vs. malignant/premalignant conditions) based on microscopic evaluation by a blinded consultant histopathologist.
次要结局
未报告次要终点
研究者
DR. IZAM AFZAL
Principle Investigator
University of Health Sciences Lahore