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The Effect of Appendectomy on the Clinical Course of Ulcerative Colitis, the ACCURE trial.


- candidate number9408
- NTR NumberNTR2883
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-mei-2011
- Secondary IDs 
- Public TitleThe Effect of Appendectomy on the Clinical Course of Ulcerative Colitis, the ACCURE trial.
- Scientific TitleThe Effect of Appendectomy on the Clinical Course of Ulcerative Colitis: A prospective randomized multicenter trial.
- ACRONYMACCURE-trial
- hypothesisLaparoscopic appendectomy ameliorates the disease course and prevents colectomies, corticosteroid use and immunomodulation in newly diagnosed ulcerative colitis.
- Healt Condition(s) or Problem(s) studiedInflammatory bowel disease, Ulcerative Colitis
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2011
- planned closingdate30-dec-2013
- Target number of participants182
- InterventionsElective laparoscopic appendectomy in day care setting.
- Primary outcomeThe one year cumulative UC relapse rate (defined both clinically and endoscopically as Mayo-score ≥5 with endoscopy score of 2 or 3).
- Secondary outcome1. 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.
- TimepointsBoth patient groups will be followed for one year. In the 2nd half 2012 the clinical study will start, the total inclusion is scheduled to take place within 2 years.
- Trial web sitehttp://ibd-amc.nl/clinical-trials-in-ibd/accure-trial/
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD candidate M.E. Stellingwerf
- CONTACT for SCIENTIFIC QUERIES T.J. Gardenbroek
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryThe suspicion of an inverse relationship between ulcerative colitis (UC) and appendectomy originates from the observation in 1987 that the rate of prior appendectomy was significantly lower in UC patients compared to healthy controls. Since then, evidence has been accumulating indicating that the appendix has an immunomodulatory role in ulcerative colitis. Several case series have reported on the reduction of colectomy rates following appendectomy in UC patients. If an appendectomy can protect diagnosed UC patients from future steroid usage, immunosuppression and colectomy, this simple intervention may improve the course of the disease and the quality of life in these patients tremendously and reduce costs for medications and surgeries to an important extent. The annual incidence of ulcerative colitis amounts to 6-8 new cases per 100,000. The majority of these patients currently needs lifelong treatment with medication including biologicals and 10-20 per cent of the patients requires colectomy within one year. Up to 30%-40% of patients with UC ultimately require surgery. The purpose of the current study is to assess prospectively whether laparoscopic appendectomy alters the course of ulcerative colitis and to study histological and immunological characteristics of the resected appendices from UC patients compared to several control groups. The study is a multicenter study comparing patients between 18 and 80 years with newly diagnosed mild to moderate ulcerative colitis that have been treated medically for their first relapse with 5ľASA preparations and/or corticosteroids. Once clinical and endoscopic remission has been attained, patients will be randomized (1:1) to undergo an elective and ambulatory laparoscopic appendectomy in day care setting. The primary endpoint is the one year cumulative UC relapse rate in both groups.
- Main changes (audit trail)11-Jul-2012: There have been several changes to the protocol - NM
Previous inclusion criteria:
1. Age in between 18 and 60 years;
2. Newly diagnosed ulcerative colitis;
3. Clinical (Mayo score <3) and endoscopic (Mayo score 0 or 1) remission;
4. Negative stool culture (including Gonorrhea and Chlamydia);
5. Obtained informed consent;
6. A completed IBDQ and EQ-5D before randomization.
Old secondary outcomes:
1. Time to relapse;
2. Health related quality of life (Euroqol and IBDQ);
3. Disease activity, as measured with the Mayo score.
Old timepoints:
Both patient groups will be followed for one year or until relapse. In the 2nd half 2011 the clinical study will start, the total inclusion is scheduled to take place within 2 years.
- RECORD3-mei-2011 - 22-jun-2016


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