CTRI/2025/05/087641尚未招募2 期
Role of thermal ablation in the management of symptomatic cervical ectropion.
medical education and research cellpgimer1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月26日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of patients reporting symptomatic relief
研究概览
简要总结
women with complain of recurrent or persistent vaginal discharge with cervical ectropion on per speculum examination will be recruited in the study after meeting eligibility criteria. thermalablation will be performed using wisap thermoablator ,which is a hand held device. the tip of probe will be placed at ectropion area for 40 sec and ablation will be performed. women with infective discharge will be first treated and then thermalablation will be performed. After ablation women will be followed at 6wks and 3m for symptom improvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 30.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Multiparous Cervical ectropion on per speculum examination Persistent or recurrent vaginal discharge Normal cervical cancer screening test Normal or inflammatory cervical cytology Willing to participate.
排除标准
- •Unmarried Nulliparous women Postmenopausal women Abnormal screening test (cytology or hr-HPV DNA) Previous cervical ablation procedure or loop electrosurgical excision procedure LEEP Past history of CIN Immunocompromised Immunosuppressant Pregnancy or Lactation Warts/ any other acute vulvovaginal infection Distorted shape of cervix due to old tears.
结局指标
主要结局
Proportion of patients reporting symptomatic relief
时间窗: assessed at 6wks and 3months.
Change in symptom assessed through visual analog scale
时间窗: assessed at 6wks and 3months.
次要结局
- adverse effect(time taken for resolution of symptoms)
研究者
研究点 (1)
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