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临床试验/NCT04319861
NCT04319861已完成不适用

Long-term Clinical Results With the Use of an Anal Fistula Plug for the Treatment of Trans-sphincteric Anal Fistulas

Zhen Jun Wang1 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2008年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
207
试验地点
1
主要终点
Healing rate

研究概览

简要总结

In this study, we retrospectively reviewed clinical data of patients who were treated with an anal fistula plug for trans-sphincteric anal fistulas, and evaluated the long-term therapeutic effect of an anal fistula plug and the risk factors impacting anal fistula healing. In addition, we assessed the effects of post-operative changes on anal function, as well as the risk factors affecting anal function.

详细描述

Treatment of anal fistulas, especially involving significant anal sphincters, continues to represent a challenge for surgeons. Surgery has been the mainstay of treatment, and the ideal goal of anal fistula treatment is to obliterate the fistulous tract, while preserving the anal sphincter and avoiding fecal incontinence. The anal fistula plug is a sphincter-sparing procedure that uses biological substances to close an anorectal fistula. Several studies have preliminarily shown that the anal fistula plug had advantages of simple and repeatable application, preservation of sphincter integrity, minimal patient discomfort, and subsequent surgical options if needed. The healing rate of anal fistula plug varied widely, which range from 14% to 88%, and no significant effect on anal function in the short term. Therefore, long-term observation and a large sample size are needed to evaluate the long-term healing rate of an anal fistula plug, and the effect on anal function. The aim of this study is to assess the long-term therapeutic effect of an anal fistula plug in patients with trans-sphincteric fistula-in-ano, as well as the impact on anal function.

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
15 Years 至 69 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with trans-sphincteric anal fistula.
  • The case information was complete.
  • Not receive other treatment previously.

排除标准

  • Fistulas related to Crohn's disease, ulcerative colitis or anorectal tumors.
  • Underwent surgical incision and drainage for acute perianal infections within 3 months.
  • Multiple fistula tracts >
  • Poor underlying condition and unable to tolerate surgery.

结局指标

主要结局

Healing rate

时间窗: 8 years postoperatively

The healing rate of anal fistula plug in 8 years postoperatively

次要结局

  • Anal function(8 years postoperatively)

研究者

发起方
Zhen Jun Wang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhen Jun Wang

Professor

Beijing Chao Yang Hospital

研究点 (1)

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