Crohn's disease Digestive System Crohn's disease [regional enteritis]
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged greater than or equal to 18 years, either sex 2. Ileal stenosis or stricture due to Crohn's disease with indication for ileocaecal resection or right hemicolectomy 3. First perianastomotic relapse of bowel inflammation with indication for surgical resection
Exclusion criteria
Exclusion criteria: 1. Other intestinal inflammation due to Crohn's disease 2. Aged less than 18 years 3. Pregnancy 4. Given or assumed indication for post-operative medication with azathioprine 5. Impossibility of post-operative dose reduction for cortisone medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endoscopic proven perianastomotic relapse of bowel inflammation one year after surgical resection (using an endoscopic relapse score). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Endoscopic proven perianastomotic relapse of bowel inflammation three years after surgical resection (using an endoscopic relapse score): one and three years after randomisation 2. Symptomatic perianastomotic relapse (diarrhoea, pain, fever, weight reduction, increasing inflammation parameters in blood): one and three years after randomisation 3. Relapse with indication for surgical resection: one and three years after randomisation 4. Anastomotic leaks: day of discharge from the hospital | — |
Countries
Germany