CO2 LASER Vaporization vs Electrosurgical Fulguration for the Surgical Management of Perianal Condyloma: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- Recurrence of Anal Condyloma
研究概览
简要总结
Perianal condyloma are skin- colored and fleshy lesions caused by various variants of Human Papilloma Virus (HPV), most commonly 6 and 11. The treatment modalities available include topical options like podophyllin, imiquimod cream, trichloroacetic acid and cryotherapy, injectable options like interferon and 5-fluoroucil, and surgical options like excision, fulguration, cryotherapy, and laser removal. However, the treatment is usually short-lived, and the patients are subjected to multiple repeat procedures because of high recurrence and low clearance rates. Surgical management has the highest clearance rate. There are several surgical modalities including excision, electrosurgical fulguration (ESF), and LASER vaporization. LASER techniques work directly to destroy/transect the lesion, cause necrosis of infected keratinocytes and induce local inflammation. LASER treatment is also reported to have minimal local surrounding tissue injury and sphincter injury, and less pain and discomfort. For this reason, LASER therapy has been increasingly used to remove anogenital warts, and is a standard of care treatment of condyloma. We hypothesize that LASER vaporization is effective to treat perianal condyloma and may have clinical benefits over ESF. We will compare postoperative outcomes such as pain, healing, cosmesis and recurrence following either treatment method.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (>18) treated in our CRS department for perianal condyloma, not previously treated surgically, English speaking patients.
排除标准
- •<18, intra-anal condyloma, previously treated for condyloma, other skin diseases in the perianal region, limited English proficiency.
- •Adults unable to consent- exclude
- •Individuals who are not yet adults (infants, children, teenagers)- exclude
- •Pregnant women- exclude
- •Prisoners- exclude
结局指标
主要结局
Recurrence of Anal Condyloma
时间窗: 6 months
Comparison of recurrence of anal condyloma within 6 months among LASER group and ESF group.
次要结局
- Incidence of Treatment-Emergent complications(6 months)
- Comparison of Postoperative Pain and associated outcomes(6 months)
研究者
Gerald Gantt
Principal Investigator
University of Illinois at Chicago
