CTRI/2024/05/067002尚未招募Phase 3 4
Efficacy of chromo-hysteroscopy vs conventional hysteroscopy in detection of endometrial pathology in abnormal uterine bleeding
Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月15日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- to compare the efficacy of chromohysteroscopy with conventinal hysteroscopy in detecting endometrial abnormalities in cases of AUB
研究概览
简要总结
- abnormal uterine bleeding affects 5-35% women visiting the gynaecology outpatients department in hospitals and affects the daily life of the woman.
- endometrial sampling is required to reach the final diagnosis. Traditionally, AUB has been investigated with blind conventional procedures like D and C, fractional endometrial biopsy etc., but now, diagnostic hysteroscopy with hysteroscopic guided biopsy has become the gold standard diagnostic tool for evaluation of AUB. Although hysteroscopy facilitates adequate visualization of the uterine cavity and detection of intracavitary lesions, a normal appearance of endometrium in conventional diagnostic hysteroscopy does not ensure a normal histology.
- Endometrial pathology in these normal looking areas may be detected by chromo hysteroscopy. Chromoendoscopy with iodine has been widely used in gastrointestinal imaging to identify mucosal abnormalities by enhancing tissue characterization and differentiation.
- Based on this technique, Methylene blue can be applied to the endometrium during conventional hysteroscopy to detect endometrial pathology that may not be seen by the naked eye during hysteroscopy. This led to the existence of the technique of chromo hysteroscopy. Chromo hysteroscopy, may help to decrease the subjective error and increase the sensitivity as compared to simple diagnostic hysteroscopy, and thus, is being studied for diagnosing AUB in this study.
- Diagnostic hysteroscopy would be performed using a 4.2mm hysteroscope in OT under anesthesia. The uterine cavity would be visualized and any abnormal area would be noted. For chromo hysterography, 10ml of 5% Methylene blue dye would be instilled through the water inlet channel. The endometrial staining would be classified into two types - diffuse light blue staining and focal dark blue staining. Endometrial biopsies would be taken from the dark and diffusely stained areas and the abnormal and normal areas visualized on conventional hysteroscopy.
- At the end of examination, dilatation & curettage would be done. The obtained samples would be subjected to histopathological examination. The histopathology report would be compared between the samples retrieved by conventional hysteroscopy and chromo hysteroscopy.
- the aim is to evaluate and compare the efficacy of chromo hysteroscopy with conventional hysteroscopy in detecting endometrial pathology in cases of AUB
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.age above 18 years 2.consenting 3.vitally stable 4.no gross findings on systemic and lab examination 5.fit for anesthesia.
排除标准
- •1.minor 2.not consenting 3.patients with gross abnormality on clinical examination or radiological investigations 4.diagnosed case of Ca endometrium/ cervix.
结局指标
主要结局
to compare the efficacy of chromohysteroscopy with conventinal hysteroscopy in detecting endometrial abnormalities in cases of AUB
时间窗: at the first surgical sitting
次要结局
- 1.To classify the causes of Abnormal Uterine Bleeding based on hysteroscopy & histopathological findings of the endometrial samples retrieved(2.To correlate the hysteroscopic finding with the histopathological findings of the endometrial samples retrieved.)
研究者
Megha Neelesh Karnik
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research (DU)
研究点 (1)
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