1. Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial)
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Ernst Jan Spillenaar Bilgen, Arnold van de Laar, Willem A Bemelman, Richard van Hillegersberg, Sjoerd D J van der Werf, Donald L. van der Peet, Rosalie C Mallant, C. Janneke van der Woude, Pascal E P Dekkers, Henricus B Stockmann, Annet M C J Voorburg, B W Marcel Spanier, A W Marc van Milligen de Wit, Juda Vecht, Huib A. Cense, Esther C. J. Consten, Liekele Oostenbrug, Quirijn A. J. Eijsbouts, Maarten J Boom, Menno A. Brink, Robert E G J M Pierik, Henk A van Heukelem, Willem A. Marsman, Martin H M G Houben, Bas Oldenburg, Mirjam A. G. Sprangers, Rogier M P H Crolla, Karien F Bruin, Clemens Bolwerk, Jan van den Brande, Michael F. Gerhards, Ad A. van Bodegraven, Dirk J. de Jong, Warner Bruins Slot, Andreas Marinelli, Hubert A Prins, Bart A. van Wagensveld, Robert P. Bleichrodt, Meindert N. Sosef, Djuna Cahen, Edwin S. van der Zaag, Laurents P. S. Stassen, Nancy A M van Ooteghem, Jeroen M Jansen, Paul H. P. Davids, Emma J. Eshuis, T Hauwy Goei, Theo J.M. van Ditzhuijsen, Anna A. W. van Geloven, Anne-Marie van Berkel, Patrick M.M. Bossuyt, Johan F. Lange, Pieter C. F. Stokkers, Rob J. Lieverse, John Maring, Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Surgery, Cancer Center Amsterdam, Amsterdam Public Health, Medical Psychology, Epidemiology and Data Science, Other departments, Public Health, Gastroenterology & Hepatology, Gastroenterology and hepatology, Medical oncology, Internal medicine, and Other Research
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musculoskeletal diseases ,110 027 Speech Training Project ,Tissue engineering and reconstructive surgery [UMCN 4.3] ,medicine.medical_specialty ,Colon ,Anti-Inflammatory Agents ,lcsh:Surgery ,law.invention ,Study Protocol ,Crohn Disease ,Quality of life ,Randomized controlled trial ,Refractory ,Ileum ,Recurrence ,law ,Colon surgery ,Multicenter trial ,medicine ,Humans ,Ileitis ,skin and connective tissue diseases ,Crohn's disease ,business.industry ,Antibodies, Monoclonal ,General Medicine ,lcsh:RD1-811 ,Nutrition and Health [UMCN 5.5] ,medicine.disease ,Infliximab ,Surgery ,Pathogenesis and modulation of inflammation [N4i 1] ,stomatognathic diseases ,140 000 Learning & Plasticity ,Quality of Life ,140 003 Learning processes ,Laparoscopy ,business ,medicine.drug - Abstract
Contains fulltext : 69534.pdf (Publisher’s version ) (Open Access) BACKGROUND: With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction.The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohn's disease of the distal ileum with respect to quality of life and costs. METHODS/DESIGN: The study is designed as a multicenter randomized clinical trial including patients with Crohn's disease located in the terminal ileum that require infliximab treatment following recent consensus statements on inflammatory bowel disease treatment: moderate to severe disease activity in patients that fail to respond to steroid therapy or immunomodulatory therapy. Patients will be randomized to receive either infliximab or undergo a laparoscopic ileocolic resection. Primary outcomes are quality of life and costs. Secondary outcomes are hospital stay, early and late morbidity, sick leave and surgical recurrence. In order to detect an effect size of 0.5 on the Inflammatory Bowel Disease Questionnaire at a 5% two sided significance level with a power of 80%, a sample size of 65 patients per treatment group can be calculated. An economic evaluation will be performed by assessing the marginal direct medical, non-medical and time costs and the costs per Quality Adjusted Life Year (QALY) will be calculated. For both treatment strategies a cost-utility ratio will be calculated. Patients will be included from December 2007. DISCUSSION: The LIR!C-trial is a randomized multicenter trial that will provide evidence whether infliximab treatment or surgery is the best treatment for recurrent distal ileitis in Crohn's disease. TRIAL REGISTRATION: Nederlands Trial Register NTR1150.
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- 2008
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