inflammatory bowel disease Ulcerative colitis
Conditions
Interventions
Laparoscopic appendectomy in day-care setting
Sponsors
Academisch Medisch Centrum
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Age 16 years and older - Established diagnosis of ulcerative colitis - Active disease (defined both clinically and endoscopically as Mayo-score >=5 with endoscopy score of 2 or 3) despite standard step-up treatment including optimized biological treatment - Obtained written informed consent
Exclusion criteria
Exclusion criteria: - Prior appendectomy or other abdominal surgery. - Any suspicion of Crohn*s disease. - Toxic megacolon - 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 - Daily dosage of oral prednison equal to or higher than 20 mg - History of dysplasia and/or cancer in bowel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Steroid-free remission rate (total mayo score | — |
Secondary
| Measure | Time frame |
|---|---|
| - Time to remission - Endoscopic disease activity after 6 and 12 months, measured with the Mayo score - Reduction of medical therapy including corticosteroids - Failure (upscaling of medication, start trial medication or colectomy) - Biological free remission - Global, health related, and disease specific quality of life (EORTC-QLQ-C30-QL, EQ-5D-5L, and IBDQ) - Patient self-reported assessment of symptomatology (MYMOP score) - Percentage of patients interested in appendectomy after counselling - Cost-effectiveness - Radiological analysis of preoperative ultrasound images of the appendix to determine characteristics predictive of response. The main - Pathological analysis of coecal biopsies and resection specimen to determine histological characteristics predictive of response. | — |
Countries
Netherlands
Outcome results
None listed