NL-OMON20965已完成不适用
Surgical closure versus anti-TNF in the treatment of perianal fistulas in Crohn’s Disease (PISA-II): a comprehensive cohort design
Crohns and Colitis Foundation and ZonMw0 个研究点目标入组 116 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
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
入选标准
- •= 18 years
- •-Active perianal fistula
- •- High perianal fistula tract (intersphincteric, transsphincteric, suprasphincteric) located in the upper two-thirds of the external sphincter or puborectal muscle.
- •-Fistula with one internal opening (based on MRI imaging). The number of external fistulas does not have to be taken into account.
- •-Written informed consent
排除标准
- •- Proctitis (defined as any active mucosal inflammation or ulcer > 5mm in the rectum)
- •- Anorectal stenosis (defined as the impossibility to introduce a proctoscope)
- •- Submucosal fistulas & low intersphincteric fistulas (lower one-third of external sphincter)
- •- Rectovaginal fistula
- •- Multiple internal openings
- •-Previous failure of anti-TNF treatment for perianal fistula
- •- Patients with a stoma
- •- Dementia or altered mental status that would prohibit the understanding and giving of informed consent
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