Treatment of Anal Fistula With Laser Mediated Heat Coagulation Using Fistula Laser Closure (FiLaC)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- Region Skane
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Healing
研究概览
简要总结
The purpose of this study is to determine whether treatment with laser coagulation is an effective and safe treatment option for patients with anal fistula
详细描述
Treatment of anal fistula remains a challenge - the only truly effective treatment available (fistulotomy) involves very high rates of anal incontinence if performed on the majority of patients, and a vast number of alternative, sphincter-preserving treatments have been developed and evaluated in the past decades. The treatment of anal fistula with laser coagulation causes the fistula to collapse and subsequently heal, without having to add any external materials. The available published studies show that the treatment is safe regarding infection and incontinence, and that a majority of the patients treated show complete healing. There is however a need for more prospective studies to ascertain these preliminary facts.
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
- 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
- •Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
- •Subject must be at least 18 years of age
- •Subject must have a verified anal fistula (by transanal ultrasound performed by treating surgeon)
- •Subject must have a clean and infection-free fistula tract (no cavities seen on transanal ultrasound)
- •Subject must be able to comply with study and study follow-up requirements.
排除标准
- •Subject with anorectal fistula due to Crohn's disease
- •Subject has an undrained abscess in fistula tract (cavities as seen on transanal ultrasound)
- •Subject has fistula with side tracts (as seen on transanal ultrasound)
- •Subject is unable or unwilling to provide informed consent.
研究组 & 干预措施
Laser coagulation
Treatment of anal fistulae meeting the inclusion criteria
干预措施: Laser Coagulation (Procedure)
结局指标
主要结局
Healing
时间窗: 12 months
Fistula closure success at 12 months is defined as complete healing of the fistula tract and external opening at clinical examination and on a transanal ultrasound performed by the examining surgeon (yes/no).
次要结局
- Incontinence(12 months)
- Infection(12 months)