NCT01602081已完成不适用
Ligation of the Intersphincteric Fistula Tract With Tissue Graft Placement for Treatment of Persistent Trans-sphincteric Anal Fistula
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 8
- 主要终点
- Closure of the anal fistula
研究概览
简要总结
The LIFT+Biodesign® study is a post-market observational study to evaluate the rate of fistula closure in patients with persistent trans-sphincteric anal fistula who receive the Biodesign® Tissue graft as part of their LIFT procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Persistent primary or recurrent trans-sphincteric anal fistula
排除标准
- •Patients with prior fistulotomy, fistulectomy, LIFT, cutting seton or advancement flap procedure
- •Fistula with multiple tracts
- •Recto-vaginal fistula
- •Active infection in the anal fistula
- •Physical allergies or cultural objections to porcine products
- •Patient is not medically fit to undergo the LIFT procedure as judged by the treating physician
- •Previous diagnosis of collagen disorder
- •History of Crohn's Disease, Irritable Bowel Syndrome, radiation therapy in the rectoanal region
结局指标
主要结局
Closure of the anal fistula
时间窗: 6 months
次要结局
- Closure of the anal fistula(12 months)
研究者
研究点 (8)
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