Anal fistula
Conditions
Brief summary
Improvement in fistula disease after 15 months of treatment to a degree where it enables surgical closure of fistula
Detailed description
Drop in Perianal Disease Activity index > 2 after 6, 12 and 15 months of treatment, Improvement evaluated by MRI after 15 and 30 months of treatment or prior, Improvement of Quality of Life (CAF-QOL-score) after 6, 12, 15 and 30 months, Patients who fulfill primary endpoint and achieve fistula healing 3, 6 and 12 months after fistula closure, Time from treatment start to achieved primary endpoint, Changes in fistula classification and activity, Complications to the medical treatment
Interventions
DRUGAZATHIOPRINE
DRUGINFLIXIMAB
DRUGSALINE
DRUG8 mm kalktablet indkapsuleret i gelatine
Sponsors
Aarhus University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in fistula disease after 15 months of treatment to a degree where it enables surgical closure of fistula | — |
Secondary
| Measure | Time frame |
|---|---|
| Drop in Perianal Disease Activity index > 2 after 6, 12 and 15 months of treatment, Improvement evaluated by MRI after 15 and 30 months of treatment or prior, Improvement of Quality of Life (CAF-QOL-score) after 6, 12, 15 and 30 months, Patients who fulfill primary endpoint and achieve fistula healing 3, 6 and 12 months after fistula closure, Time from treatment start to achieved primary endpoint, Changes in fistula classification and activity, Complications to the medical treatment | — |
Countries
Denmark
Outcome results
None listed