NCT03321266已完成不适用
A Retrospective Review of the Use of the Cook Biodesign® Fistula Plug (C-FPS-0.2, C-FPS-0.4, and C-FPS-0.7) to Treat Anorectal Fistulas
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 4
- 主要终点
- Rate of fistula closure
研究概览
简要总结
The study is a retrospective review of the use of the Biodesign® Fistula Plug (C-FPS-[X]). A total of 73 patients will be enrolled who have had a fistula plug placed to treat anorectal fistulas and will therefore be eligible for statistical analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have had surgery to treat anorectal fistula where the Biodesign® Fistula Plug was placed during the procedure
排除标准
- •Patients not receiving the Biodesign® Fistula Plug for treatment of their anorectal fistula
结局指标
主要结局
Rate of fistula closure
时间窗: up to 2 years
Absence of drainage from the external fistula opening with complete epithelialization of the external fistula opening upon clinical exam.
次要结局
未报告次要终点
研究者
研究点 (4)
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