THERMAL ABLATION VERSUS LOOP ELECTROSURGICAL EXCISION PROCEDURE (LEEP)IN TREATMENT OF CERVICAL INTRAEPITHELIAL NEOPLASIA CIN 2&3 :AN EXPLORATORY TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate acceptability effectiveness and side effects in women of CIN 2 3 lesions treated with Thermal coagulation and LEEP.
研究概览
简要总结
PRIMARY OBJECTIVE
-
To evaluate acceptability, effectiveness and side effects in women of CIN 2 & 3 lesions treated with Thermal coagulation and LEEP.
-
Comparing the results in the two treated groups, one by loop electrosurgical excision procedure (LEEP) and one by thermal ablation, in terms of acceptability, efficacy, complications, disease recurrence/ persistence and on follow up of 6 months.
SECONDARY OBJECTIVES
**1.**To examine and compare the effect of Thermal ablation and LEEP on overall sexual satisfaction and other specific aspects of sexual function in women in CIN 2 & 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Women with age group 25-55 years 2.Women who have histologically confirmed CIN 2 & 3 lesions 3.Women who have been screened positive (positive with high risk HPV or visual inspection with acetic acid / VIA) in a screen-and-treat strategy.
- •4.Women with abnormal cytology (High-grade Squamous Intra-epithelial Lesion / HSIL) 5.Transformation zone (TZ) is fully visible, whole lesion is visible and it does not extend into the endocervix, or the lesion is type 1 TZ; or the lesion is type 2 TZ where the probe tip will achieve complete ablation of the SCJ epithelium, i.e., where it can reach the upper limit of the TZ.
排除标准
- •â€¢Women with obvious growth on cervix.
- •â€¢Women with high index of suspicion of invasive cancer cervix .
- •â€¢Women with lesion occupying more than two quadrants of cervix or with vaginal and/or endocervical extension.
- •â€¢Lesion is type 3 TZ (TZ is not fully visible because it is endocervical); or lesion is type 2 TZ where the SCJ is out of reach of the probe tip.
- •â€¢Pregnant women •Women with severe debilitating disease •Women with history of pelvic irradiation.
结局指标
主要结局
To evaluate acceptability effectiveness and side effects in women of CIN 2 3 lesions treated with Thermal coagulation and LEEP.
时间窗: 1,3,6 months
2. Comparing the results in the two treated groups, one by loop electrosurgical excision procedure (LEEP) and one by thermal ablation, in terms of acceptability, efficacy, complications, disease recurrence persistence and on follow up of 6 months.
时间窗: 1,3,6 months
次要结局
- To examine and compare the effect of Thermal ablation and LEEP on overall sexual satisfaction and other specific aspects of sexual function in women in CIN 2 & 3.(6months)