Multimodal treatment of perianal fistulas in Crohn's disease: seton vs anti-TNF vs advancement plasty - PISA-trial

Academisch Medisch Centrum0 个研究点目标入组 42 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

Trial is onging in other countries

•- * 18 years;- Written informed consent;- High tract (intersphincteric, transsphincteric, suprasphincteric) perianal fistula located in the upper ;two-thirds of the external sphincter ;- Fistula with one internal opening (based on MRI imaging). The number of external fistulas does not ;have to be taken into account;- Both new fistulas or recurrent active fistula (defined as any producing fistula)

•- 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;- Seton in situ for more than 3 months;- Use of Anti-TNF medication during last 3 months;- Previous Anti-TNF medication without any effect on perianal fistulas;- Previously demonstrated allergy for anti-TNF medication. If this allergy only concerns the chimeric ;monoclonal mouse-antibody infliximab, the patient could be randomised for adalumimab;- Patients with a stoma;- Immunocompromised patients (i.e. haematological malignancies, HIV/AIDS, bone marrow ;transplantation, splenectomy, genetic disorders such as severe combined immunodeficiency, ;chemotherapy, dialysis, solid organ transplant and long term immunosuppressant use such as ;corticosteroids in patients with rheumatoid arthritis);- Life expectancy < 2 years;- The inability of reading/understanding and filling in the questionnaires;- Dementia or altered mental status that would prohibit the understanding and giving of informed ;consent

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