Comparison of thermoablation with cryotherapy for the treatment of symptomatic cervical ectropion:A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in the size of the cervical ectropion 6 & 12 weeks after colposcopic guided thermoablation.
研究概览
简要总结
Although most occurrences of cervical ectropion are asymptomatic,it can occasionally cause vaginal discharge,post coital bleeding ,amd intermenstrual bleeding. The most pouplar form of treatment for this condition is cryotherapy, however it has drawbacks such as excessive watery discharge and li,ited application in larger lesions.A relatively recent technique called thermoablation is quick and capable of treating larger lesions . However there is paucity of studies that show it’s effectiveness in treating cervical ectropion. This study is hence being undertaken to study the effect of thermoablation on the size of ectropion, symptomatology and quality of life (QOL) in women with symptomatic cervical ectropion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women >21 years of age with symptomatic cervical ectropion including persistent discharge ,post coital bleeding and intermenstrual bleeding.
- •Persistence of atleast 1 symptom for 3 months or recurrence of symptoms twice in 3 months despite obtaining medical treatment.
- •Normal PAP smear.
- •Visible cervical ectropion >0.5 cm from the external os.
- •Willingness of the patient to participate in the study.
- •Women understanding spoken or written hindi.
排除标准
- •Women with diagnosed Carcinoma Cervix or pre-invasive lesion of cervix in the past.
- •Previous cervical ablation procedures and loop electrosurgical excision procedure (LEEP).
- •Pregnant women.
- •Women with active vaginal infection.
- •Women currently using oral contraceptive pills.
结局指标
主要结局
Change in the size of the cervical ectropion 6 & 12 weeks after colposcopic guided thermoablation.
时间窗: Baseline | 6 weeks | 12 weeks
次要结局
- Change in the WHOQOL-BREF questionnaire score.
- Change in the severity of symptoms assessed with the VAS analogue scale.
- Percentage of women experiencing side effects at 6 weeks & 12 weeks post procedure