perianal fistula
Conditions
Interventions
Group I: chronic seton (seton drainage for 1 year) and 6MP
Group II: anti-TNF (seton for 6 weeks under anti-TNF, followed by seton removal
with continuation of medication for 1 year) and 6MP
Group II
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - * 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)
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter is the number patients needing fistula-related re-intervention(s). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are the number of patients with closed fistulas and the percentage of closed fistulas (based on MRI) after 18 months, and the number of antibiotic courses that was required during treatment. Furthermore we evaluate the Perianal Disease Activity Index, quality of life, and costs. | — |
Countries
Netherlands
Outcome results
None listed