Cryotherapy for Human Papillomavirus Clearance in Biopsy-confirmed Cervical Low-grade Squamous Intraepithelial Lesions: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of Patients With Human Papillomavirus Clearance
研究概览
简要总结
Persistent human papillomavirus (HPV) infections is the single necessary cause of cervical cancer. Cervical cancer is still the major health problem in the developing countries. It has been the first rank women's cancer in Thailand for many decades. Approximately 10-20% of Thai women have the high-risk HPV (HR-HPV) infections in their cervices. This will frequently lead to low-grade squamous intraepithelial lesions (LSILs) (10%), high-grade squamous intraepithelial lesions (HSILs) (0.8%), and finally, cervical cancers (0.16%) within 10-20 years. The treatment options for LSILs are either observation or ablative surgery. However, in our institute, cryotherapy, which is the one of ablative surgery, is more frequently used to comfort our women. It is not only effective but safe with only minimal side effects; watery leukorrhea for 2-4 weeks, and local cervical infection not more than 1%. Contraindication to this procedure are active cervical infection, lesion of 2 mm-larger than probe, lesion inside cervical os and suspected cervical cancer. Additionally, in developing countries such as Thailand, this treatment is safe, acceptable, feasible and effective. Patients with LSILs could also have this treatment in some rural area from the 10-days trained nurses. Fortunately, recent reports showed that cryotherapy has abilities not only in clearing LSILs but also clearing the HPV infections, its necessary cause. However, there are no randomized controlled trial compared its clearing ability between observation and cryotherapy. Therefore, a randomized controlled trial is needed to demonstrate that. Findings from this trial will contribute enormously to older women who already get infected by HPV. Aside from preventing cervical cancer in treated woman, cryotherapy could also give her relief from worrying about having a time-bomb like HPV infection in her cervix.
详细描述
This will be a hospital-based, parallel, assessor-blinded, randomized controlled trial. Study subjects refer to LSIL patients, more than 30 years-old, with positive HPV testing who do not have any contraindication of performing cryotherapy. Therefore, after recruitment LSIL patients whose age more than 30 years-old, we will exclude only those who have negative HPV testing or any contraindications of performing cryotherapy. The primary outcome is HPV clearance (negative HPV testing for the baseline HPV type) at 12 months after the treatment. Subjects will be randomly allocated to be treated by cryotherapy or observation only by using block randomization with varied block size of 2, 4, and 6. The sample size of at least 25 for each arm was planned to have the power of 80% to detect 20% difference rates of HPV clearance after 12 months of treatment between the two arms, with significance level of 0.05, two-sided test.
Study population:
Biopsy-confirmed LSIL patients, age more than 30 years-old, referred to either Srinagarind Hospital's, Khon Kaen Hospital's, or Roi Et Hospital's colposcopic clinics.
Inclusion criteria:
- Baseline HPV testing is positive.
- Be able to give their informed consent to this study.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Biopsy-confirmed LSIL patients
- •Age more than 30 years-old
- •Baseline HPV testing is positive.
- •Be able to give their informed consent to this study.
排除标准
- •Having active cervical infection
- •Having lesion of 2 mm-larger than probe
- •Having lesion inside cervical os
- •Having suspected cervical cancer lesion
结局指标
主要结局
Number of Patients With Human Papillomavirus Clearance
时间窗: 12 months
At 12 months after treatment, a patient with negative results for HPV testing of previous types was considered as a clearance.
次要结局
未报告次要终点
