inflammatory bowel disease Ulcerative colitis
Conditions
Interventions
Patients will be randomized to laparoscopic appendectomy or to no appendectomy
in day care setting.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Aged 18 years and older - Established diagnosis of ulcerative colitis (any extent of disease) - Disease relapse within 12 months of randomisation medically treated until remission - Clinical (Mayo score
Exclusion criteria
Exclusion criteria: - Prior appendectomy or other major abdominal surgery precluding safe appendectomy - Any suspicion of Crohn's disease - Disease recently treated with biologicals within 3 months prior to inclusion - Severe disease ever treated with biologicals and stopped due to secondary non-response - Toxic megacolon or severe ongoing colitis at time of randomimsation - Patients with active extra-intestinal infections, liver or kidney failure, mayor lung and heart co-morbidity. - Insufficient command of Dutch or cognitively unable to complete Dutch questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The one year UC relapse rate (defined both clinically and endoscopically as Mayo-score >=5 with endoscopy score of 2 or 3). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of relapses per patient 2. Time to first relapse. 3. Health related quality of life (EQ-5D, EORTC-QLQ-C30-QL, IBDQ and a 'global change question'). 4. Disease activity, as measured with fecal calprotectin and the Mayo score. 5. Number of colectomies | — |
Countries
Netherlands
Outcome results
None listed