Visual Inspection With Acetic Acid of The Cervix Versus Colposcopy in Screening and Detection of Cervical Intraepithelial Neoplasia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- VIA Versus Colposcopy in terms of in terms of sensitivity and specificity
研究概览
简要总结
The aim of this study is to compare the effectiveness of visual inspection with acetic acid (VIA) versus colposcopy in terms of sensitivity and specificity in diagnosis of pre-malignant cervical lesions among women, and to assess the awareness of women regarding cervical cancer screening methods.
详细描述
Method of study:
Medical and surgical history of the patients will be taken, clinical examinations of the patients will be performed and routine laboratory investigations will be done.
Patients will be asked to empty their bladder and positioned in the lithotomy or dorsal supine position on the examination table. Standard infection control measures will be followed, including hand hygiene and use of sterile gloves and speculum.
Visual Inspection with Acetic Acid (VIA) VIA will be conducted by trained gynecology residents under consultant supervision. A 5% acetic acid solution will be applied to the cervix, and after one minute, the cervix will be inspected under adequate light. The appearance of acetowhite areas will be considered VIA positive, indicating possible precancerous changes.
Colposcopy Women who are candidate for colposcopy assessment or with abnormal Pap smear will be referred for colposcopic evaluation using a binocular colposcope (magnification: 5×, 10×, and 20×) with a green filter to assess vascular patterns.
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age from 25 to 65 years.
- •Patient undergoing cervical cancer screening using VIA and colposcopy.
- •Women with symptoms such as white discharge, post-coital bleeding, and intermenstrual bleeding.
- •Women with the clinically unhealthy cervix (erosion, bleeding on touch, simple leukoplakia, keratinization)
- •Women with Pap smear showing dysplasia.
排除标准
- •• Pregnant women (if VIA or colposcopy is contraindicated).
- •Women with obvious invasive cervical cancer diagnosed previously.
- •Women who refuse to provide informed consent or are unable to cooperate with the examination.
- •Women having active vaginal bleeding.
- •Any past treatment for cervical lesions.
结局指标
主要结局
VIA Versus Colposcopy in terms of in terms of sensitivity and specificity
时间窗: 2 weeks
Patients will be observed for any immediate discomfort or minor complications such as spotting, mild cramping, or vaginal irritation following VIA, colposcopy, or biopsy. All patients will be advised on post-procedure care, including avoiding vaginal do
sensitivity and specificity in diagnosis of pre-malignant cervical lesions among women
时间窗: From enrollment to the the result at 14 days
Patients will be observed for any immediate discomfort or minor complications such as spotting, mild cramping, or vaginal irritation following VIA, colposcopy, or biopsy. All patients will be advised on post-procedure care, including avoiding vaginal douching, sexual activity, or use of tampons for a few days, if a biopsy will be performed. Results of the VIA, colposcopy, and histopathology will be explained to the patients, and appropriate follow-up or referral will be arranged for those with CIN 2, CIN 3, or carcinoma. Patients will be instructed to report any unusual bleeding, pain, or discharge immediately to the clinic.
次要结局
未报告次要终点
研究者
Bassam Mahmoud Abdallah
Bassam Mahmoud Abdallah Mahmoud
Sohag University