Efficacy and Acceptability of Thermal Ablation in the Treatment of Cervical Neoplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Cure rate based on colposcopy and histology assessment
研究概览
简要总结
Longitudinal study in two referral centers in Morocco to evaluate the effectiveness, the acceptability and safety of thermal ablation in the treatment of cervical neoplasia.
详细描述
The study population consisted of women with a positive Visual Inspection with Acetic Acid (VIA) screening test referred for ablative treatment. A total of 119 women with lesions eligible to ablative treatment were counselled and treated by thermal ablation. Informed consent was signed by each participant. Just after treatment, the patients were inquired about the level of pain during the procedure, and their level of satisfaction with the treatment. The women were followed-up at 6 weeks for any complication and re-assessed by colposcopy and biopsy at 12 months for any persistent or recurrent lesion and for any adverse event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women having been screened positive at VIA at the primary health center and referred to the diagnosis centre of Fez and Taza for ablative treatment by thermal ablation
排除标准
- •Lesion occupying the 4 quadrants of the cervix
- •Not visible squamous columnar junction (not Type 1 TZ (transformation zone))
- •Vaginal or endocervical lesion
- •Lesion subjective of cervical cancer
研究组 & 干预措施
Thermal ablation Arm
Treatment of cervical neoplasia by thermal ablation
干预措施: Treatment of cervical neoplasia by thermal ablation (Procedure)
结局指标
主要结局
Cure rate based on colposcopy and histology assessment
时间窗: 1 year
Cure rate is assessed after 1 year of treatment by colposcopy. Persistent or recurrent lesions are treated by thermal ablation, excision or hysterectomy according to the lesion size and characteristics.
次要结局
- Acceptability of thermal ablation in terms of adverse events(1 year)
- Acceptability of thermal ablation in terms of satisfaction level(Within one hour after procedure)
- Safety of TA in terms of major adverse events(1 year)