Carbon Dioxide Laser Ablation Versus Electrocoagulation - a Prospective, Randomized Single-center Trial Comparing Two Surgical Treatments in Women Undergoing Therapy for Condyloma Acuminata
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Cosmetic result
研究概览
简要总结
In a randomized clinical trial of 114 women undergoing Treatment for condyloma acuminata, two surgical methods, the carbon dioxide laser Ablation and the excision by electrocoagulation, will be compared. The primary outcome of the study is the cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step numerical rating scale (NRS), secondary outcomes are intervention time, operative complications, subjects and users satisfaction, postoperative pain and recurrence of genital warts.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •informed consent
- •women with anogenital affection of condyloma acuminata
排除标准
- •significant language barrier
- •pregnancy
- •unwillingness to participate
- •the use of blood thinner or known coagulation disorder
- •the use of immunosuppressive medicament
- •HIV-Infection
- •malignant diseases
- •local therapy within 8 weeks before Treatment
- •wound healing disorder
研究组 & 干预措施
Carbon dioxide Laser ablation
Excision of genital warts using a carbon dioxide laser, ie CO2 Laser
干预措施: Carbon dioxide Laser ablation (Device)
Electrocoagulation
Excision of genital warts using a superficial electrical coagulation mode, ie spray coagulation
干预措施: Electrocoagulation (Device)
结局指标
主要结局
Cosmetic result
时间窗: 6 weeks
Cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step numerical rating scale (NRS)
次要结局
- Operation time(20 minutes)
- Recurrence of genital warts(12 months)
- Operative complications(14 days)
- users satisfaction(30 minutes)
- Postoperative pain(5 hours)
- Subjects satisfaction(12 weeks)
- Cosmetic result(12 weeks)
- Subjects satisfaction(6 weeks)
- Recurrence of genital warts(12 weeks)
研究者
Clemens Tempfer, MD
Principal Investigator
Ruhr University of Bochum