Efficacy of Topical 95% Trichloroaceteic Acid in the Treatment of CIN 1 or Less After Low-grade Abnormality of Screening Test: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of participants with cytologic examination, HPV testing and colposcopic examination with biopsy ( Efficacy of 95%Trichloroacetic acid in the treatment of CIN1 or less)
研究概览
简要总结
To evaluate the efficacy of topical 95% TCA in the treatment of CIN 1 or less after low grade abnormality of screening test
详细描述
The patients meeting inclusion criteria were initially divided into two groups which are no lesion and having lesion at cervix on colposcopic examination.
Participant in no lesion group were divided into two group, recieving 95% Trichloroacetic acid (intervention) plus aceteic acid (commonly apply at cervix during colposcopic examination) applying to the cervix at T-zone and Acetic acid alone group.
We follow-up each group for 6 months to evaluate the outcome using cytologic examination, HPV testing and colposcopic examination (also biopsy if lesion is seen) compare to previous result (before treatment)
In the group having lesion at cervix, we initially biopsy the lesion and wait for pathologic result. If the pathologic results are high-grade lesion e.g. HSIL, we exclude them from this study. On the contrary, if the pathologic result s are low-grade lesion, we divided them into two group, normal pathologic exam and low-grade abnormality on pathologic examination. Both of them are divided into two groups and follow-up for 6 months, similar to the no lesion group
* During colposcopic examination, we also repeat cytologic examination and HPV testing as well
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who have low-grade abnormality result such as ASC-US, LSIL, HPV 16/18 positive, persistent HPV infection after cervical cancer screening test
- •No history of endometrial or cervical cancer
- •Pregnancy test negative
- •Good communication in Thai language
- •Vouluntarily participate to the study
排除标准
- •Pregnancy test positive after participate in the study
- •Pathologic result from colposcopic biopsy (before intervention) is high-grade abnormality such as HSIL, CIN2-3 or AIS
研究组 & 干预措施
TCA plus acetic acid 1
No lesion group,
干预措施: Trichloroacetic acid (Drug)
TCA plus acetic acid 2
Having lesion with normal pathologic examination
干预措施: Trichloroacetic acid (Drug)
TCA plus acetic acid 3
Having lesion with low-grade abnomality on pathologic examination,
干预措施: Trichloroacetic acid (Drug)
结局指标
主要结局
Number of participants with cytologic examination, HPV testing and colposcopic examination with biopsy ( Efficacy of 95%Trichloroacetic acid in the treatment of CIN1 or less)
时间窗: 6 months after intervention
using cytologic examination, HPV testing and colposcopic examination with biopsy (if having lesion) compare to previous results If all of the test's results are normal, we consider it as remission of CIN1 or less \*normal means: Cytologic examination = Negative for intraepithelial lesion or malignancy HPV testing = no HPV detected Colposcopic examination not seen any lesion = normal (not perform biopsy) Colposcopic examination with biopsy = normal pathlogic result
次要结局
- Having abnormal vaginal bleeding or not? which is recorded by questionnaire(immediately after intervention, up to 2 weeks after intervention)
- Having leukorrhea or not? which is recorded by questionnaire(immediately after intervention, up to 2 weeks after intervention)
- Pain after treatment which evaluated by using visual analogue scale(immediately after intervention, up to 2 weeks after intervention)