A comparison of endometrial pipelle aspiration versus hysteroscopy guided biopsy in determining etiopathology of postmenopausal bleeding in a tertiary care centre in Thrissur
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- To compare the efficacy of endometrial pipelle sampling and hysteroscope guided biopsy in determining histopathology of patients with postmenopausal bleeding.
研究概览
简要总结
Even though for Abnormal Uterine Bleeding, pipelle is found to be as effective as hysteroscopy, there are not many studies comparing the two in postmenopausal bleeding and it is unclear of the efficacy of pipelle endometrial sampling in detecting significant endometrial pathologies. This study is designed to compare the outcomes of endometrial pipelle aspiration and hysteroscopic biopsy in women presenting with postmenopausal bleeding
**RESEARCH HYPOTHESIS -**There is a change in efficacy between endometrial pipelle sampling and hysteroscopy guided biopsy in histopathological evaluation of postmenopausal bleeding.
Sampling Procedure -
The procedure will be done in Operation Threatre under Anaesthesia.
Patient will be positioned, painted and draped under aseptic precautions .
Endometrial pipelle will be introduced into the uterus and sampling sone. The endometrial sampling specimen will be sent for HPE. This is followed by the hysteroscopic procedure and sample will be sent for HPE.
The Histopathology Report of both will be compared to assess the concurrence and also the corelation with endometrial thickness will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women presenting with symptoms of postmenopausal bleeding Ultrasonogram showing endometrial thickness ≥4mm Women with recurrent postmenopausal bleeding irrespective of ultrasonogram endometrial thickness Women who are fit for hysteroscopy.
排除标准
- •Lower genital tract infections Pelvic inflammatory disorders Coagulation disorders Patient who has Cervical pathology/ Vaginal pathology.
结局指标
主要结局
To compare the efficacy of endometrial pipelle sampling and hysteroscope guided biopsy in determining histopathology of patients with postmenopausal bleeding.
时间窗: The histopathology results are sought 10 days after the procedure. The histopathology reports of both the procedures are compared.
次要结局
- Hysteroscope as a better investgation of choice for postmenopausal bleeding(The secondary outcome is obtained at time of procedure upto 10 days after procedure when histopathology results are sought.)
研究者
JOEL KOLANKANNI JOY
AMALA INSTITUTE OF MEDICAL SCIENCES