NCT03776825Unknown不适用
Use of Permacol Paste in Perianal Crohn's Disease
Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年2月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Perianal fistula closure rate
研究概览
简要总结
The purpose of this study is to collect data about the efficacy of Permacol Paste treatment in perianal Crohn's Disease.
详细描述
This is an observational prospective cohort study aimed to assess the efficacy of Permacol Paste treatment in perianal Crohn's Disease, by evaluating the healing rate and quality of life of 20 patients prospectively indicated to Permacol Paste treatment during one year.
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
- •Age > 18, any sex
- •Diagnosis of CD at least 6 months earlier in accordance with clinical, endoscopic, histological an/or radiological criteria
- •Presence of perianal fistulas with maximum 3 external openings and a maximum of 2 internal openings, assessed by physical examination and MRI
- •Non-active or mildly active luminal CD defined by a CDAI < 220
排除标准
- •CDAI > 220
- •Dominant luminal active CD requiring immediate surgical or medical therapy
- •Fistula with > 3 external openings and > 2 internal openings
- •Severe active proctitis and/or rectal stenosis
- •Abscess or pelvic collection > 2 cm diameter
- •Concomitant rectovaginal fistulas
- •Concomitant steroid treatment or treated with steroids in the last 4 weeks
结局指标
主要结局
Perianal fistula closure rate
时间窗: 12 months
Complete fistula closure will be defined as absence of spontaneous suppuration or suppuration on applying gentle pressure
次要结局
- Patients quality of life(12 months)
- Patients continence(12 months)
研究者
研究点 (1)
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