CTIS2022-502263-38-00招募中1 期
Infliximab for non-Crohn Anal Fistulas
Aarhus University Hospital0 个研究点目标入组 44 人开始时间: 2022年11月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •1.Complex (i.e. intershincteric or low transsphincteric fistulas with extension, high transsphincteric- ,supra- or ekstrasphincteric fistulas cryptoglandular fistulas that persist in spite of 6 months seton drainage and repeated curettage every 8- 12 weeks and where the presence of extensions and/or inflammatory activity contradicts surgical closure of the fistula, 2.Not diagnosed with Crohn´s disease implying a.Normal ileocolonoscopy < 6 months b.Normal capsule endoscopy of the small bowel < 6 months c.No granulomas in tissue samples from external fistula opening, 3.Age 18-65 years, 4.Speaks and understands Danish, 5. Received surgical standard treatment (repeated curettage and seton) for at least 6 months
排除标准
- •1.Pregnancy, 2.Colostomy, 3.Smoker or non-smoker for < 8 weeks, 4.Anti-TNFa treatment contradicted (chronic infections or malignancy), 5. MRI-scan contradicted, 6. Females of child-bearing age not using contraception
研究者
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