跳至主要内容
临床试验/NCT04161469
NCT04161469Unknown不适用

Laser Closure of Anal Fistula (FiLaC); Do we Need to Close Internal Orifice?

Surp Pırgiç Armenian Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Change from perianal fistula disease severity score at 6 months

研究概览

简要总结

Laser closure of the perianal fistula is the minimally invasive and low complication rate procedure which is a life-saving way for complex fistulas, preserving anal sphincter injury. Unfortunately, wide range success rate reported before (30-80%), the investigators are searching to reach better rates. Internal closure of the fistula orifice offered by some authors. The investigators are aimed to identify the efficiency of this.

详细描述

Despite the developments in the surgical field, the treatment of anal fistula is still a challenging problem, especially in complex, transsphincteric cases. The surgical treatment aims to avoid recurrences and also to preserve normal sphincter functions. The FiLaC procedure was recently reported non-invasive technique in perianal fistulas for treatment and preserving anal sphincter function with a good success rate. In 2018, one of our colleagues published a 40% complete healing rate by using only FiLaC technique in 103 consecutive perianal fistula patients (Prof. Cem Terzi). Some authors advocated that the closure of the internal orifice increasing the success rate. Therefore, the investigators decided to modify the surgical technique focusing closure of the internal opening associated with the FiLaC procedure.

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

入选标准

  • complex anal fistula
  • high anal fistulas
  • recurrent anal fistulas

排除标准

  • superficial anal fistulas
  • multibranching anal fistulas

结局指标

主要结局

Change from perianal fistula disease severity score at 6 months

时间窗: 6th month after the surgery

0: no active disease or complete healing, 1. slight drainage with minimal symptoms, 2. persistent symptomatic drainage, 3. painful symptomatic drainage, 4. severe perianal disease potentially requiring diversion

次要结局

未报告次要终点

研究者

发起方
Surp Pırgiç Armenian Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kursat Serin

Asistant Profesor

Surp Pırgiç Armenian Hospital

研究点 (1)

Loading locations...

相似试验