NCT00545441已完成不适用
A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 7
- 主要终点
- Healing Success
研究概览
简要总结
The purpose of this study is to determine whether the Surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap 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
- 否
入选标准
- •Over eighteen years old
- •Clinical diagnosis of primary anal fistula categorized as transsphincteric, suprasphincteric, or extrasphincteric in nature
- •Pre-placement of seton required for at least 6 weeks prior to surgical treatment
- •Willing to sign informed consent and share data with study sponsor and Surgisis AFP manufacturer
排除标准
- •Recurrent fistula tracts
- •J-pouch fistulas
- •Superficial fistulas
- •Fistulas with active abscess, infection, or acute inflammation
- •History of Chron's Disease
- •History of Ulcerative Colitis
- •History of HIV or other immune system disease
- •History of collagen disease
- •History of radiation to the anorectal region
- •Allergies to pig tissue or pig products
- •Religious or cultural objection to the use of pig tissue
结局指标
主要结局
Healing Success
时间窗: 12 months
Healing was defined as "closure of external opening with absence of abscess, drainage and pain."
次要结局
未报告次要终点
研究者
研究点 (7)
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