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

Academic Medical Center0 个研究点目标入组 126 人开始时间: 2013年7月25日最近更新: 2019年2月28日

试验速览

暂无简介。

•- = 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)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 116
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 10

•- 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

发起方

Academic Medical Center