Moderate to severe active ulcerative colitis refractory against basic therapy.
Conditions
Interventions
Group 1: Group 1: Study Group
Intervention: Appendectomy
Prospective, non-randomised, according to Propensity-Matching
Group 2: Group 2: Control Group
Intervention: Vedolizumab
according to the scient
Sponsors
Ev. Krankenhaus Kalk
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Complete colonoscopy within 4 weeks, macroscopically and histologically demonstrating moderately active ulcerative colitis (regardless of the pattern of involvement) - MAYO score between =6 and =10 - Clinical refractoriness to at least 4 weeks of therapy with mesalazine and/or corticosteroids - Decision by the treating physician to escalate therapy with biologics or small molecules - Negative stool culture including C. difficile - Negative detection of CMV (histology)
Exclusion criteria
Exclusion criteria: - Patients with a history of appendectomy - Crohn's disease - History of immunosuppression up to 4 weeks prior to study start or currently (except glucocorticosteroids) - Major abdominal surgeries that would hinder a simple appendectomy or Risk factors include: severe (toxic) ulcerative colitis that makes emergency colectomy likely; contraindications for vedolizumab; severe symptomatic extraintestinal manifestations; severe (treatable) comorbidity of the kidneys, liver, lungs, heart, or other organ systems; active (treatable) cancer; and pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical steroid-free remission at week 24 (Remission MAYO Score =2, no subscore >1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical remission at week 24 (remission MAYO score =2, no subscore >1) regardless of corticosteroid use. Clinical improvement at week 24 (FAS) definition: Improvement of the MAYO score (Table 1) by at least 3 points and an improvement of at least 30% compared to the baseline score, with a decrease in the rectal bleeding subscale of at least 1 point or an absolute bleeding score of 0 or 1, respectively. | — |
Countries
Germany
Contacts
Public ContactWolfgang Kruis
Ev. Krankenhaus Kalk
Outcome results
None listed