NCT01584752终止不适用
Clinical Multicenter Study of the Efficacy of Gore-BioA Fistula Plug in High Transsphincteric Perianal Fistulas
Central Finland Hospital District4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Healing of the fistula
研究概览
简要总结
This is a prospective clinical study on the efficacy of Gore-BioA fistula plug in high transsphincteric fistulas. Follow-up time is six months
详细描述
Inclusion criteria for the study is a patient with ultrasound or MRI proven high transsphincteric perianal fistula. Patients with Crohns disease, immunosuppressive medication, anovaginal fistula, radiation therapy or chemotherapy are excluded. A Seton is placed in the fistula track for two months before the application of the plug. Patients are followed up for six months. Symptoms of fecal incontinence before and after intervention are monitored with the Cleveland clinic incontinence score.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years, male or female
- •High cryptoglandular perianal fistula
- •Written approval for the study
- •Sufficient co-operation for the study
- •Localization of the fistula by ultrasound or MRI
排除标准
- •Crohns disease
- •Immunosuppressive treatment
- •Anovaginal fistula
- •Radiation therapy 6 months before study
- •Chemotherapy 6 months before study
- •Low- or intersphincteric fistula
结局指标
主要结局
Healing of the fistula
时间窗: 6 months
次要结局
- Symptoms of fecal incontinence(6 months)
研究者
研究点 (4)
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