Ulcerative Colitis, Inflammatory Bowel Disease
Conditions
Interventions
Elective laparoscopic appendectomy in day care setting.
Sponsors
Academic Medical Center Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age in between 18 and 60 years; 2. Established diagnosis of ulcerative colitis, diagnosed less than 1 year prior to randomisation (any extent of disease); 3. Recent disease relapse less than 4 months prior to randomisation medically treated until remission; 4. Treatment of UC only with 5-ASA (oral and/or topical) and/or with a maximum of 1 steroid course; 5. Clinical (Mayo score <3) and endoscopic (Mayo score 0 or 1) remission; 6. Negative stool culture (including Gonorrhea and Chlamydia); 7. Obtained written informed consent.
Exclusion criteria
Exclusion criteria: 1. Prior appendectomy or other abdominal surgery; 2. Any suspicion of Crohn's disease; 3. Severe colitis (defined as: disease treated with immunomodulators or biologicals, disease not reactive to a maximum of one course of steroids, remission not achieved by steroids and 5-ASA therapy in <=8 weeks, disease requiring hospitalisation, toxic megacolon); 4. Patients with active extra-intestinal infections, liver or kidney failure, mayor lung and heart co-morbidity; 5. Insufficient command of Dutch or cognitively unable to complete Dutch questionnaires.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The one year cumulative 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 and costs (EQ-5D, EORTC-QLQ-C30-QL and IBDQ); 4. Disease activity, as measured with the Mayo score; 5. Number of semesters in remission since beginning of disease and current relapse; 6. Number of colectomies. | — |
Contacts
Public ContactM.E. Stellingwerf
AMC
Outcome results
None listed