Evaluating 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
- 86
- 试验地点
- 2
- 主要终点
- Cure rate based on VIA and colposcopy assessment
研究概览
简要总结
Longitudinal study in Burundi 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 an abnormal VIA test or an abnormal colposcopy examination. A total of 86 women with lesions eligible to ablative treatment were counselled and treated by thermal ablation. Informed consent was signed by each participant. Just after treatment, they were inquired about the level of pain during the procedure, and their level of satisfaction with the treatment. They were followed-up at 6 weeks for any complication and re-assessed by VIA and colposcopy 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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women residing in Burundi and referred to the tertiary hospital after a positive VIA test
排除标准
- •Lesion occupying the 4 quadrants of the cervix
- •Not visible squamous columnar junction (not Type 1 TZ)
- •Vaginal or endocervical lesion
- •Lesion subjective of cervical cancer
结局指标
主要结局
Cure rate based on VIA and colposcopy assessment
时间窗: 1 year
Effectiveness is measured by the cure rate after 1 year based on VIA and colposcopy assessment.
Acceptability of thermal ablation
时间窗: At day 1
Measured by the satisfaction level using a nine-level Likert scale (from 1. Very unsatisfied to 9. very satisfied).
Safety of thermal ablation
时间窗: 1 year
Measured by existence of severe adverse events during the follow-up period.
次要结局
未报告次要终点