Randomized Conrtolled Study: Fistula Laser Closure (FiLaC™) vs Monopolar Coagulation for Treatment of Complex Anal Fistulae.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Rate of healing
研究概览
简要总结
This is a randomized, controlled, parallel study to compare the results of treatment for patients with transsphincteric fistulas-in-ano.
详细描述
We are planning to eroll 120 patients in this study,the duration of the stady be 3 years. Each of two groups will include 60 people. Pationts in the first group will be assigned to get treatment of the fistula-in-ano by laser thermo-obliteration (FiLAC™), patietns of the second group will forego monopolar coagulation of the fistulas tract with suturing the internal fistulas opening.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent to the study;
- •Patients with high transsphincteric fistula (>1/3), suprasphincteric fistula whithout abscesses;
- •The presence of a formed fistulous tract > 2 cm in length.
排除标准
- •Suprasphincteric fistula with abscesses or infiltrates;
- •Extrasphincteric fistula;
- •Length of fistula tract < 2 cm;
- •The presence of sever scars in the region of internal fistula opening, wide fistula opening > 5 mm;
- •Crohn's fistulae
研究组 & 干预措施
Fistula-tract laser closure (FiLAC™)
The treatment technique consists of laser coagulation of fistulous tract walls with a diode laser with a wavelength of 1470 nm, which leads to thermo-obliteration of the fistulous tract.
干预措施: Fistula-tract laser closure (FiLAC™) (Procedure)
Fistula monopolar cogulation
The treatment technicque consists of monopolar coagulation of fistulous tract walls with suturing the internal fistulas opening.
干预措施: Monopolar coagulation of fistulous tract (Procedure)
结局指标
主要结局
Rate of healing
时间窗: 60 days
healing
次要结局
未报告次要终点