The Effect of Appendectomy on the Clinical Course of Ulcerative Colitis, the ACCURE trial.
Recruiting
- Conditions
- <p>Ulcerative Colitis, Inflammatory Bowel Disease</p>
- Registration Number
- NL-OMON22414
- Lead Sponsor
- Academic Medical Center Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 182
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);
Exclusion Criteria
1. Prior appendectomy or other abdominal surgery;
2. Any suspicion of Crohn's disease;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The one year cumulative UC relapse rate (defined both clinically and endoscopically as Mayo-score =5 with endoscopy score of 2 or 3).</p>
- Secondary Outcome Measures
Name Time Method <p>1. Number of relapses per patient;<br>2. Time to first relapse;<br>3. Health related quality of life and costs (EQ-5D, EORTC-QLQ-C30-QL and IBDQ);<br>4. Disease activity, as measured with the Mayo score;<br>5. Number of semesters in remission since beginning of disease and current relapse;<br>6. Number of colectomies.</p>