Efficacy, Acceptability, and Safety of Laser Ablation in the Treatment of High-grade Cervical Lesions: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 308
- 主要终点
- the rate of HSIL recurrence
研究概览
简要总结
Cervical laser ablation is an effective, minimally invasive treatment with a low incidence of perinatal complications and minimal impact on fertility. Research has confirmed that laser ablation treatment of cervical HSIL (including CIN2 and CIN3) is effective and feasible and is useful for young CIN3 patients who wish to get pregnant in the future. There have been no randomized clinical trials of laser ablation therapy for cervical HSIL in Chinese women. This study focuses on the application of laser ablation in the treatment of cervical HSIL, explores the efficacy, feasibility, and safety of laser ablation in the treatment of cervical HSIL, and strives to promote the reasonable application of laser ablation in the treatment of cervical HSIL.
详细描述
- Background This study focuses on the application of laser ablation in the treatment of cervical HSIL, explores the efficacy, feasibility, and safety of laser ablation in the treatment of cervical HSIL, and strives to promote the reasonable application of laser ablation in the treatment of cervical HSIL.
- Research objects Young patients with cervical HSIL underwent colposcopic evaluation, completed cervical biopsy, and were pathologically confirmed to be eligible for ablation.
- Methods 3.1 Sample size This study was a randomized controlled trial with parallel design. HSIL recurrence rate was the primary endpoint. According to previous literature reports, it is estimated that the recurrence rate of HSIL in the laser treatment group is 15%. The recurrence rate of HSIL in the resection group was 5%. Let α=0.05 (both sides), hold =0.80. Using PASS 11 software, the sample size of both groups was 138 cases. Assuming that the loss of follow-up rate of the study subjects was 10%, the sample size of each group was 138÷0.9=154 cases. Therefore, 308 patients were intended to be included in the study.
3.2 Statistical methods SPSS 24.0 software will be used for statistical analysis of all data. Measurement data with normal distribution will be described by mean ± standard deviation. Independent sample t-test or rank sum test will be used for inter-group comparison, and paired sample t-test will be used for intra-group comparison before and after treatment. Counting data will be expressed as examples or percentages (%), and the Chi-square test will be used for comparison between groups. The Kaplan-Meier method will be used to calculate the recurrence rate, and the rank sum test will be used to evaluate the difference between the two groups. Cox regression model will be used to analyze the factors influencing prognosis. P < 0.05 will be considered statistically significant. 4. Results The primary endpoint is the HSIL recurrence rate at 12 months after treatment.
Other subjects were secondary study endpoints shown as follows:
Intraoperative and postoperative complications and side effects, including bleeding, pain, infection, cervical secretions, and healing; Psychological state change; Satisfaction; Cervical length; Recurrence rate; Fees
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
- None
入排标准
- 年龄范围
- — 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •< 40-year-old
- •Cervical HSIL confirmed by colposcopic biopsy pathology
- •Cervical transformation zone type 1 or 2
- •The lesion is completely visible and does not extend into the cervical canal, and the lesion area is less than 50% of the cervical surface area
- •Colposcopic evaluation ruled out invasive cancer
- •Voluntary participation in the study with full and informed consent
排除标准
- •Cervical transformation zone type 3
- •Glandular epithelial lesions
- •Lesions greater than 50% of cervical surface area, or with vaginal and vulvar intraepithelial lesions
- •The upper margin of the lesion was not visible or extended into the cervical canal
- •Cervical tube sampling was diagnosed with CIN2+ or CIN that could not be graded
- •Cervical biopsy is not sufficient to confirm a tissue diagnosis
- •Suspected invasive cancer
- •History of cervical surgery
- •Pregnancy or planning a pregnancy during study participation
- •Autoimmune or immune deficiency diseases
- •Long-term use of immunosuppressive drugs
结局指标
主要结局
the rate of HSIL recurrence
时间窗: 12 months after treatment
12 months after the treatment, TCT, HPV, colposcopy, and biopsy will be tested again. If the result of the biopsy is HSIL again, we will record it as HSIL recurrence.
次要结局
- the satisfaction with the treatment(8 weeks and 12 months after treatment)
- Psychological state change related to the treatment(8 weeks and 12 months after treatment)
- the length of the cervix(8 weeks and 12 months after treatment)